AGIR Study: Angio-Seal in Interventional Radiology: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for AGIR Study: Angio-Seal in Interventional Radiology (NCT01911403), a randomized na study. The primary outcome is Number of Patients With Mobilization Time Between 0-4 Hours.

2. Clinical Question

3. Trial Design

The AGIR Study (NCT01911403) is a randomized, parallel-group clinical study of Angio-Seal versus manual compression for femoral-artery access closure during interventional radiology procedures. The record lists the study phase as not applicable and identifies Abbott Medical Devices as the sponsor. It lists enrollment of 123 and a terminated status. The recorded start is 2010-12, and primary completion is recorded as 2014-08. The reason for termination and the timing of the status change are not reported in the registry record.

The registry describes the study as designed to demonstrate superiority of Angio-Seal with an unchanged risk profile. It does not report the original sample-size assumptions, a protocol-level definition of superiority, or the statistical plan used for the sponsor’s analysis. The comparison is randomized, but the method used to generate or conceal the allocation sequence is not reported in the registry record. Masking is listed as none. The record does not specify whether outcome assessment was blinded or whether procedures differed in other ways beyond the assigned closure approach.

The primary outcome is a count of patients with mobilization time between 0–4 hours at discharge. The posted results identify 61 participants in the Angio-Seal group and 62 in the manual-compression group. The status of a trial as terminated does not, by itself, explain whether enrollment, follow-up, or outcome collection was complete. A reason for termination, a participant flow account, and details about the analysis population are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Number of Patients With Mobilization Time Between 0-4 Hours, measured over At discharge.

The primary endpoint counts participants whose mobilization time was between 0–4 hours, assessed at discharge. The registry defines mobilization time as the time when a patient receives authorization to flex the leg, sit, or walk. It is therefore a threshold-based count: a participant either meets the stated time window or does not, according to the endpoint definition. The registry does not give a separate measure of actual walking, the duration of mobilization, or the precise procedure for determining the authorization time.

This endpoint addresses an aspect of recovery after femoral-artery access closure: how soon the participant is authorized to move. Comparing the count in each group describes how frequently the specified early-mobilization outcome was recorded under each closure procedure. It does not, on its own, describe all aspects of recovery, access-site safety, or the overall risk profile. Those questions require other outcomes and sufficiently detailed definitions and analyses.

The outcome is recorded as a participant count rather than a continuous time measurement. That makes the comparison about the proportion meeting a prespecified interval, not about the average time to mobilization. The registry record does not report the rationale for choosing the 0–4-hour interval, whether the threshold was established before enrollment, or how missing endpoint observations were handled.

7. Results Posted in the Registry

• Manual Compression: 22.6% (14/62) versus 85.2% (52/61) on control; risk difference -62.7 percentage points (95% CI -76.4 to -49.0), risk ratio 0.26 (0.17–0.42); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Patients With Mobilization Time Between 4-48 Hours

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Manual Compression: 77.4% (48/62) versus 14.8% (9/61) on control; risk difference 62.7 percentage points (95% CI 49.0 to 76.4), risk ratio 5.25 (2.83–9.73); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Manual Compression than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Number of Patients With Any Complications

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Manual Compression: 9.7% (6/62) versus 9.8% (6/61) on control; risk difference -0.2 percentage points (95% CI -10.6 to 10.3), risk ratio 0.98 (0.34–2.88); unadjusted two-proportion z-test p = 0.976.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Manual Compression and the control. The interval gives the range of effects that remain compatible with the data.

Number of Patients With Time to Hemostasis Between 0-4 Minutes

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Manual Compression: 1.6% (1/62) versus 88.5% (54/61) on control; risk difference -86.9 percentage points (95% CI -95.5 to -78.3), risk ratio 0.02 (0.00–0.13); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Manual Compression than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcomes span mobilization, complications, hemostasis, discharge timing, and device deployment success. Among the outcomes with numerical results, the pattern is directionally consistent with more participants in the Angio-Seal group meeting the early-mobilization and short-time-to-hemostasis definitions, while the recorded counts for any complications are the same in the two groups. This gives context to the primary endpoint, but it does not make the different measures interchangeable: each has its own definition, assessment time, and potential sources of measurement variation.

The registry lists six secondary outcomes. Numerical results are posted for early mobilization, any complications, and hemostasis within 0–4 minutes. Results for mobilization between 4–48 hours are also posted. Numerical results for time to discharge from the interventional radiology department and Angio-Seal deployment success are not reported in the registry record. No secondary reported analyses are listed for the outcomes whose results are posted.

Unadjusted secondary results carry less weight because multiple outcomes create more opportunities for apparently notable findings to occur by chance. The registry does not report a multiplicity plan or adjusted p-values. Secondary outcomes can be useful for describing patterns and generating questions, but they should not be treated as if each were a separately confirmed primary finding. The posted outcome pattern does not establish a combined benefit-harm conclusion or replace the primary endpoint analysis.

The outcomes also differ in what they capture. An interval for mobilization or hemostasis reflects whether a participant met a threshold; discharge time concerns a different stage of care; deployment success applies specifically to Angio-Seal. Interpretation across these measures requires outcome definitions and analysis details that are not all reported. Their results are best considered alongside the primary outcome, the uncertainty in each comparison, and the incomplete reporting of some listed secondary outcomes.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Patients With Mobilization Time Between 4-48 Hours
• Number of Patients With Any Complications
• Number of Patients With Time to Hemostasis Between 0-4 Minutes
• Number of Patients With Time to Hemostasis Between 4-60 Minutes
• Time to Discharge From Interventional Radiology Department
• Percentage of Patients With Angio-Seal™ Deployment Success

9. Statistical Interpretation

10. Statistical Methods Explained

What does a risk difference describe?

General statistical explanation: A risk difference subtracts the event proportion in one group from the event proportion in another. Its sign depends on the order used for subtraction. In the posted primary comparison, the difference is expressed as manual compression relative to Angio-Seal. A negative value therefore corresponds to a lower recorded proportion in the manual-compression group for this event, while a positive value would correspond to a higher recorded proportion in that group. The measure is expressed on the probability scale, not as a relative ratio.

The primary endpoint is a binary outcome: each participant is counted according to whether mobilization time falls within the specified 0–4-hour interval. The posted arm counts allow the comparison to be read in terms of the observed participants and group sizes. The registry also reports the risk difference and its confidence interval. It does not report the statistical test procedure or an adjusted model for the primary result, so those should not be inferred from the displayed estimate.

How should the confidence interval be read?

General statistical explanation: A confidence interval describes the range of effect estimates compatible with the data under the method used to calculate it. A narrow interval indicates greater precision than a wide interval, but the interval does not assign a probability that the true effect lies within its particular endpoints. If an interval for a risk difference includes zero, the data are compatible with no difference under the interval’s assumptions. If the interval lies on one side of zero, the estimates in that interval share a direction. Neither situation, by itself, establishes clinical importance.

The registry gives confidence intervals for the posted comparisons, but the method used to calculate them is not reported in the registry record. The intervals should therefore be interpreted as reported, without assuming a particular adjustment, stratification, or small-sample procedure.

What does the p-value add?

General statistical explanation: A p-value describes how unusual the observed data, or data more extreme, would be under a specified null model. It is not the probability that the null hypothesis is true, and it is not a measure of the size or importance of an effect. The primary comparison has an unadjusted p-value of <0.001. The comparison for any complications has an unadjusted p-value of 0.976. These values are reported without a multiplicity adjustment in the registry record.

A small p-value for the primary result is evidence against a no-difference model under the calculation used, but it does not resolve concerns about endpoint selection, incomplete reporting, bias, or clinical relevance. A large p-value for complications is not proof that the groups have the same risk. The estimate and interval are important to read alongside the p-value.

Why do randomization and masking matter?

General statistical explanation: Random allocation is intended to make assigned groups comparable, on average, with respect to measured and unmeasured factors at baseline. It does not guarantee balance in a particular trial, nor does it prevent bias from missing outcomes, deviations from assigned procedures, or selective reporting. This registry identifies the study as randomized and parallel-group, but it does not describe sequence generation, allocation concealment, adherence, or an analysis by assigned treatment.

Masking is listed as none. In a procedural comparison, participants and clinical staff may know which closure approach is used. Knowledge of allocation can potentially influence care, recording, or outcome assessment, depending on how an outcome is measured. The record does not report whether the assessment of mobilization authorization or complications was performed by masked assessors. Those details should remain unknown rather than being assumed.

What is not established by the registry methods?

The registry record does not report a detailed statistical analysis plan, the original design assumptions, the method for handling missing observations, a prespecified analysis population, or the approach to multiple comparisons. It lists six secondary outcomes but does not provide reported analyses for all of them. The posted comparison results are therefore interpretable as the registry presents them, but there is not enough information to reconstruct the full planned analysis or determine whether all planned analyses were reported.

General statistical explanation: Over-dispersion is relevant when count data vary more than a model expects. It is not a central concern for this primary endpoint because the posted outcome is a binary participant count, not a repeated count or a continuous measure. The registry does not identify a model or report a dispersion parameter. More broadly, statistical methods should match outcome type and trial design; the exact methods used by the sponsor are not reported in the registry record.

11. Confidence Intervals and Precision

The primary risk-difference confidence interval lies entirely below zero, consistent with the direction of the posted primary estimate under the comparison’s stated ordering. The interval is the principal guide to the range of effect sizes compatible with the reported data, rather than the p-value alone. Its numerical endpoints are part of the posted result; they should be read on the risk-difference scale and not as relative risks or percentages.

The complication comparison has a confidence interval that includes zero. This indicates uncertainty about the direction and size of the difference in the recorded complication outcome. The unadjusted p-value of 0.976 is consistent with the absence of a clear statistical separation, but it does not establish equivalence. The record does not give an equivalence margin or a non-inferiority analysis.

Precision depends on both the observed counts and the method used to calculate an interval. A confidence interval can be wide even when the point estimate is near zero, and a point estimate alone does not show how uncertain the comparison is. For any complication, the posted counts are equal while the group denominators differ; the comparison should therefore be interpreted using its reported estimate and interval, rather than assuming equal risk from equal counts.

The registry does not report the confidence-interval method, adjusted intervals, or intervals accounting for multiple secondary comparisons. The available intervals quantify uncertainty for the reported comparisons under the methods used, but the record does not contain enough detail to evaluate all assumptions behind that precision. They also do not address uncertainty arising from missing outcome information or selective reporting.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for the binary outcomes in this trial. They are not total event counts. The sample-size illustrations assume a two-sided significance level of 0.05, equal allocation between the groups, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The original trial-design assumptions are not reported in the registry record, so these illustrations should not be mistaken for the assumptions used to plan the trial.

The column for 80% power gives the participants per arm estimated to provide an 80% chance of detecting the specified effect under those planning assumptions, if that effect is present and the assumptions hold. The 90% power column uses a higher target chance of detection. These are design-planning quantities, not guarantees about the result of a future or completed study. The figures are illustrations based on the observed effect, not observed power.

Rows describing 100%, 75%, and 50% of the observed effect ask what planning would look like if the target effect were the full observed effect or a smaller fraction of it. A smaller effect is harder to distinguish from random variation, so it generally requires more participants per arm for the same power target. The displayed values can change substantially with the assumed target effect, particularly when the observed difference is small. The very large planning figures for the complication comparison reflect that feature of the calculation; they do not show that such a study was planned or conducted.

The plotted planning curve should be read as an illustration of how the required group size changes with the assumed effect and power target. It is not a record of recruitment or an estimate of the study’s achieved power. The registry does not report the original sample-size justification or whether enrollment was stopped according to a prespecified rule.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.852; treatment proportion p₁ = 0.226; average p̄ = 0.539.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7049 = 1.3817.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.5483 = 0.4614.
4. n = (1.3817 + 0.4614)² / (-0.6267)² = 8.7, rounded up to 9 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.852459016393443                          # control proportion
p1 <- 0.225806451612903                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(1911403)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 9 (80% power), 12 (90% power)
 75% of observed effect: n per arm = 16 (80% power), 21 (90% power)
 50% of observed effect: n per arm = 33 (80% power), 44 (90% power)
power.prop.test: 8.7 
Simulated power at n = 9 per arm: 0.810 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple secondary outcomes in addition to the primary endpoint. It does not report whether a hierarchy among those outcomes was prespecified, whether a family-wise error or false-discovery approach was used, or whether any p-values or confidence intervals were adjusted for multiple comparisons. The posted p-values are labeled unadjusted. When many outcomes are tested, the chance of at least one apparently unusual result can increase even if none represents a real difference. This is why secondary findings generally require cautious interpretation and should not be treated as independent confirmation without a prespecified multiplicity strategy.

The record lists six secondary outcomes, but results are not reported for every listed measure. It does not explain whether those results were not collected, were unavailable, or were omitted from the registry entry. The registry also does not provide a participant-flow account, reasons for missing outcome data, imputation methods, or sensitivity analyses. It is therefore not possible to assess from the record whether missingness could have affected the comparisons.

The registry does not identify an intention-to-treat, per-protocol, or other analysis population. It gives group sizes alongside outcome counts, but does not state how participants who deviated from their assigned procedure, withdrew, or lacked an endpoint assessment were handled. The denominator used for each posted result is available in the outcome data; the reasons for any differences between enrollment and analysis are not reported in the registry record.

The study status is terminated, but the record does not state why. Termination alone does not show whether follow-up was incomplete, whether the planned enrollment was reached, or whether any stopping rule was used. Interim analyses, stopping boundaries, and the rationale for termination are not reported in the registry record. These unknowns limit assessment of the completeness and prespecification of the reported analyses.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hematoma (1.6%), minor stroke (1.6%), vessel stenosis (1.6%), deterioration of general condition (1.6%), bleeding (1.6%).

The serious adverse event figures report 3 affected participants among 61 at risk in the Angio-Seal group and 6 among 62 at risk in the manual-compression group. The other adverse event figures report 7 among 61 and 2 among 62, respectively. These are participant counts as recorded; the record does not explain whether an individual could contribute to more than one event category or how event relatedness was assessed.

The listed serious event terms include Hematoma, Minor Stroke, Vessel stenosis, Deterioration of general condition, Bleeding, and Superficial Perforation femoral artery, each reported as 1.6%. The registry does not provide additional detail about severity grading, timing, duration, outcomes, or attribution for these terms. Death counts are not reported in the registry record.

These figures describe the reported adverse-event entries; they do not establish that the groups have the same overall safety profile. The registry summary does not provide a prespecified safety margin, a comparative safety analysis, or sufficient detail to judge the completeness of event ascertainment. The study summary’s stated intention to assess an unchanged risk profile should not be read as proof of unchanged risk based on these counts alone.

16. What the Result Does, and Does Not, Mean

The posted primary result shows a difference between the groups in the count meeting the early-mobilization definition at discharge. The reported risk-difference interval lies below zero for manual compression relative to Angio-Seal, and the unadjusted p-value is <0.001. These statistics describe the primary outcome as recorded in the registry. They do not establish the size or importance of effects on outcomes that were not measured or reported.

The primary measure is authorization to flex the leg, sit, or walk within a stated interval. It is not equivalent to actual activity, discharge readiness, or a broader recovery measure. The secondary outcomes provide additional but incomplete information about mobilization, hemostasis, complications, discharge timing, and deployment success. The registry does not report numerical results for every listed secondary outcome or a multiplicity plan.

The comparison for any complications does not show a clear difference in the posted data, but that is not the same as demonstrating equal risk. A claim of equivalence or non-inferiority would require an appropriate design, a prespecified margin, and an analysis supporting that question. Those details are not reported in the registry record. Serious and other adverse-event counts should likewise be viewed as recorded event summaries, not as a complete demonstration of comparative safety.

The study is randomized, which is relevant to interpreting between-group comparisons, but the record lacks details about allocation procedures, missing data, analysis populations, and outcome assessment. The terminated status has no reported explanation. These limitations constrain what can be concluded from the registry entry and prevent a broader claim about treatment effectiveness or safety beyond the posted outcomes and their stated definitions.

In short, the posted data support a statistical difference on the defined primary mobilization outcome, while other dimensions of clinical performance and risk remain less certain or incompletely reported. The result should not be generalized beyond the participants, procedures, setting, and outcome definitions represented in the registry record.

17. Why This Trial Matters Statistically

This trial illustrates why an endpoint’s operational definition matters. The primary outcome is not a general measure of recovery; it is a count of participants authorized to flex the leg, sit, or walk within the 0–4-hour window at discharge. A clear numerical difference on that threshold-based outcome answers a narrower question than whether the overall care pathway or risk profile differs.

It also shows why effect estimates, confidence intervals, and p-values should be read together. The p-value addresses compatibility with a no-difference model under the statistical calculation, while the risk difference describes the comparison on an absolute scale and the interval conveys uncertainty. For the complication outcome, a large p-value does not prove equivalence. That distinction is important whenever a trial summary describes an unchanged risk profile without reporting a formal equivalence or non-inferiority framework.

The registry’s planning illustrations show how sample-size requirements depend on the effect assumed for planning. A calculation anchored to an observed effect is not the same as the original design rationale, and a large estimated sample size for a small observed difference should not be interpreted as a record of what investigators planned. The record does not report the original sample-size justification.

Finally, secondary outcomes and safety counts require attention to multiplicity and completeness. Multiple outcomes can create selective emphasis, and several listed outcomes lack posted results. The terminated status also lacks an explanation. These features make transparent reporting of the analysis plan, missing data, participant flow, and outcome results particularly important for assessing how far the posted findings can be trusted and generalized.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry does not report a reason for termination, a participant-flow diagram, or the completeness of follow-up. It is not possible to determine from the status alone whether outcome collection was finished as planned or whether any participants lacked assessments. Missing-data handling and the analysis population are not reported in the registry record.

Randomization is listed, but sequence generation and allocation concealment are not described. Masking is listed as none; the record does not clarify whether outcome assessors were masked. This matters because mobilization authorization and complication ascertainment can involve judgment or clinical recording. The record does not provide enough detail to assess the potential for measurement or performance bias.

The primary endpoint definition is specific, but the registry does not report why the 0–4-hour threshold was chosen or whether it was prespecified. The summary’s reference to an unchanged risk profile is not accompanied by a reported definition, margin, or formal analysis. The posted complication comparison therefore cannot establish equivalent safety.

There are multiple secondary outcomes, no reported multiplicity approach, and no secondary reported analyses. Numerical results are absent for some listed outcomes. The record does not explain whether these omissions reflect noncollection, unavailable results, or incomplete reporting. The methods for the reported confidence intervals and p-values are also not detailed.

Finally, the study population is described broadly as patients undergoing an intervention requiring femoral-artery access. Further eligibility criteria, procedural details, and information about settings or participant characteristics are not reported in the registry record. These limits make it difficult to assess applicability beyond the recorded clinical context.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: AGIR Study: Angio-Seal in Interventional Radiology — NCT01911403.
• Registry record last updated 2019-02-19; status last verified 2019-02.
• Results first posted 2015-03-11.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT01911403, the AGIR Study, is a randomized, parallel-group comparison of Angio-Seal and manual compression for femoral-artery access closure in interventional radiology. Abbott Medical Devices is listed as sponsor; the registry records enrollment of 123, a start of 2010-12, primary completion in 2014-08, and terminated status. The reason for termination is not reported in the registry record.

The primary outcome counts participants with mobilization time between 0–4 hours at discharge. The posted counts are 52 among 61 for Angio-Seal and 14 among 62 for manual compression; the unadjusted p-value is <0.001. The record lists six secondary outcomes, with results not reported for all listed measures. It does not report the original sample-size assumptions, analysis population, missing-data methods, multiplicity approach, or a formal analysis demonstrating an unchanged risk profile.