Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial (NCT05172934), a na phase 2 study. The primary outcome is Incidence of Any Intracranial Hemorrhage and Neurologic Worsening.

2. Clinical Question

The clinical question is thus a feasibility-oriented, early safety question about giving IA TNK after a specified level of reperfusion in participants who have already undergone MT. This design can document what happened in the treated group and support further study planning. It cannot estimate a comparative treatment effect against MT alone because the registry does not report a control arm.

3. Trial Design

NCT05172934 is listed as a completed phase 2 pilot trial of adjunctive intra-arterial tenecteplase following mechanical thrombectomy. The registry identifies ischemic stroke as the condition and ProMedica Health System as the sponsor. The recorded start date is 2022-04-11, and the primary completion date is 2023-09-12.

The study is described as prospective, single-center, and non-randomized. Its model is single group, with no masking. Participants were to receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard-of-care MT. The registry reports enrollment of 20. Since all participants received the intervention and there is no concurrent comparator, the design is descriptive rather than a randomized comparison of treatment strategies.

The primary outcome is assessed within 24 hours (+/- 8 hours) after IA TNK. Its definition combines intracranial hemorrhage with neurologic worsening of at least 4 NIHSS points according to ECASS-II criteria; the registry says imaging by NCCT or MRI within the timeframe was used for all enrolled study participants. The record also lists secondary outcomes: Ordinal Modified Rankin Scale Score, Final Revascularization Grade, Incidence of Any Asymptomatic Intracranial Hemorrhage, Number of Boluses, and Mortality Rate at Discharge. The registry lists six outcome measures overall, but the record does not provide analysis records for them.

Participants were followed for 3 months after treatment according to the brief summary. The follow-up duration does not establish that every listed outcome was measured at every point during that period; outcome-specific timing is not reported in the registry record beyond the primary outcome timeframe. The record does not report a protocol-level rationale for the sample size, detailed eligibility criteria, or a full statistical analysis plan. Those omissions limit assessment of how the pilot’s design choices were made.

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.

Before assignment: 218 MT AI patients assessed for eligibility. Excluded 95 patients with mTICI 3 and 16 patients with mTICI 0, 1, 2a. Excluded 87 patients on demographic and/or other inclusion/exclusion criteria.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 20 participants were included in the analysis for this outcome. Out of which only 1 participant experienced PH-1 subarachnoid hemorrhage, which may be 'possibly' due to the study drug, admitting disease, or treatment.

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.

Population: Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the 2nd European-Australasian Acute Stroke Study (ECASS II) criteria within 24 (+/- 8) hours of treatment with Intra-arterial TNK.

6. Primary Endpoint

The registry lists the primary outcome as Incidence of Any Intracranial Hemorrhage and Neurologic Worsening, measured over 24 hours (+/- 8 hours) post-treatment with intra-arterial Tenecteplase.

The primary endpoint is a participant count for intracranial hemorrhage and neurologic worsening. The registry defines the event using ECASS-II criteria and neurologic worsening of at least 4 points on the NIHSS, with assessment within 24 hours (+/- 8 hours) after IA TNK. Imaging by NCCT or MRI within this timeframe was used for all enrolled study participants, according to the record.

This type of early safety endpoint is used to identify clinically important events occurring soon after an intervention. The neurologic-worsening component provides a clinical measure, while imaging helps identify hemorrhage. As a general statistical point, a clearly defined timeframe and event criterion make outcome interpretation more consistent, but they do not establish that the intervention caused an event.

The registry reports 20 participants in the analysis for this outcome and states that one participant experienced PH-1 subarachnoid hemorrhage. It describes the possible relationship to the study drug, admitting disease, or treatment as uncertain. The record does not separately report how many participants met each component of the composite definition, or provide an independently stated numerator for the endpoint aside from that description. A composite outcome can combine different types of events; without component-level reporting, the contribution of each component cannot be evaluated separately.

The endpoint is relevant to the pilot’s early safety and feasibility focus, but it is not a measure of comparative benefit. With no control group, the observed outcome cannot show how often the same event would have occurred under another treatment strategy.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the study model as single group, with non-randomized allocation and no masking. These design features determine what statistical conclusions are available. A single-group study can count outcomes after an intervention, but it does not directly estimate a difference between intervention and control. Randomization is not reported, and there is no like-for-like control arm. Statistical methods cannot recover a missing comparison simply by re-expressing the observed count.

What does a participant count mean?

The primary outcome is described as a count of participants meeting the event definition. Counts are useful for reporting how many people in the analyzed group experienced an outcome. The registry states that 20 participants were included in the primary outcome analysis and reports one participant with PH-1 subarachnoid hemorrhage. It does not report a separate count for every component of the composite endpoint. No percentage or rate needs to be inferred to understand the basic report: the record gives a count and an analysis population, while leaving component-level detail unreported.

In general, an estimate based on a count is subject to sampling uncertainty: another group of participants from a similar setting could yield a different count. A confidence interval is a statistical way to express uncertainty around an estimated quantity. The registry record does not report a confidence interval for the primary result. Without an interval or additional analysis, the precision of the observed count cannot be assessed from the record as a formal estimate. The small pilot enrollment is particularly important when interpreting rare or uncommon outcomes, because a limited number of observations can leave substantial uncertainty about how often an event may occur elsewhere.

Why does the absent comparator matter?

A comparative trial estimates how outcomes differ between groups, subject to its design and analysis. This study reports one treatment group. Its outcomes may reflect the study drug, the admitting disease, mechanical thrombectomy, other care, or combinations of these influences. The record itself says the reported PH-1 subarachnoid hemorrhage may be possibly due to the study drug, admitting disease, or treatment. That attribution is not resolved by counting the event. A before-and-after comparison is not reported as a substitute, and no adjusted comparative analysis is listed.

As a general concept, adjustment for measured characteristics can address some observed differences between groups in certain designs, but it cannot create a concurrent control group when none is present. The registry lists no analysis records, so it does not report adjusted estimates or a specified model for the primary outcome. No claims about covariate adjustment, hypothesis testing, or model assumptions can be made from the record.

How should the planning illustrations be read?

Any sample-size illustrations associated with the posted results are planning illustrations, not observed power and not evidence about what this pilot was designed to detect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is expressed as a fraction of the observed effect. Those assumptions describe a hypothetical two-arm planning framework. They do not match the reported single-group, non-randomized design, which has no control arm. A sample-size illustration under those assumptions should not be read as a calculation of the trial’s achieved power or as the trial’s own sample-size justification. The registry record does not report that justification.

In general, a significance level is a threshold used in a planned hypothesis test, and power is a design property tied to a specified effect and analysis. Neither is a substitute for the observed outcome, nor does a planned power value quantify the certainty of a result after data collection. Because no analysis records are listed, there are no posted p-values or confidence intervals from a comparative analysis to interpret. The stated illustration assumptions alone do not supply such results.

Why can over-dispersion matter?

Over-dispersion is a general statistical issue in count data: observed variation can exceed what a simple model assumes. It can affect uncertainty estimates and model-based inference when repeated or clustered counts are being analyzed. The primary endpoint is recorded as a participant count, and the registry does not report a model for repeated counts or an over-dispersion assessment. It would therefore be inappropriate to claim that over-dispersion was tested or corrected. More broadly, the record does not say whether a particular distribution, variance assumption, or inferential method was prespecified.

These distinctions separate descriptive reporting from statistical inference. The posted primary outcome is a descriptive account of the event reported in the treated group. The study’s single-group design and absence of analysis records mean that comparative precision and statistical significance are not available in the registry record. Any further inference would require information that the registry does not report, including a detailed analysis plan and appropriate comparative data.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Intra-arterial Tenecteplase")
n      <- c(20)
events <- c(1)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intra-arterial Tenecteplase  20  1  5.0  0.1  24.9  0.9  23.6  1.2  23.8

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, including the primary endpoint and secondary outcomes covering modified Rankin Scale score, final revascularization grade, asymptomatic intracranial hemorrhage, number of boluses, and mortality at discharge. The record does not report analysis records for these outcomes. It therefore does not show which outcomes were analyzed, whether all planned outcomes were reported, or what methods were used for any analyses beyond the primary outcome description.

Multiplicity arises when several outcomes or statistical tests are considered: the chance of at least one apparently notable finding can increase if many tests are conducted without an appropriate plan. As a general statistical principle, a prespecified strategy can clarify which outcomes are primary and how secondary analyses should be interpreted. The registry lists a primary outcome and secondary outcomes, but a multiplicity adjustment or a hierarchy for testing them is not reported in the registry record. No claim about adjusted or unadjusted testing can be made.

Missing-data methods are also not reported in the registry record. The primary outcome description says 20 participants were included in its analysis and that imaging was performed within the timeframe for all enrolled study participants. That does not establish whether other outcome data were complete, how missing values were handled, or whether any participants were excluded from secondary analyses. The record does not describe imputation, sensitivity analyses, or a missing-data assumption.

The analysis population is stated for the primary outcome, but the registry does not report a broader analysis-population definition, such as whether analyses followed an intention-to-treat principle or how protocol deviations were handled. These details matter because the group included in an analysis can affect the interpretation of its results. In their absence, conclusions should remain confined to the outcome information explicitly recorded.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: carotid stenosis (10.0%), hi 1 hemorrhagic transformation (5.0%), cholecystitis (5.0%), left ventricle thrombus (5.0%), neurological decline (5.0%).

The registry’s adverse-event record lists 20 participants at risk for serious adverse events and 9 affected; for other adverse events, it lists 20 at risk and 12 affected. It also records 3 deaths. These are safety summaries for the IA TNK group. They do not establish that the drug caused the events or deaths, and the registry record does not provide a comparison group for estimating how the figures differ from another treatment strategy.

The listed serious-event terms include carotid stenosis (10.0%), HI 1 hemorrhagic transformation (5.0%), cholecystitis (5.0%), left ventricle thrombus (5.0%), neurological decline (5.0%), and aspiration pneumonia (5.0%). These labels and percentages are reported as event terms. They should not be read as a causal assessment. The record does not state whether event categories overlap, whether each participant had one or multiple events, or how event severity and timing were adjudicated.

Serious adverse events and other adverse events are separate registry categories, but the record does not clarify whether individuals appear in both. The affected counts therefore should not be added or treated as a count of unique participants. Deaths are reported separately, and the record does not specify their causes or relationship to treatment. The safety information is descriptive, with attribution and comparative risk not reported.

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

The trial documents a pilot experience with IA TNK administered after standard-of-care MT achieved mTICI 2b or 2c reperfusion. Its primary outcome is an early safety measure based on intracranial hemorrhage and neurologic worsening of at least 4 NIHSS points under ECASS-II criteria. The registry reports one participant with PH-1 subarachnoid hemorrhage among the 20 participants included in the primary outcome analysis, and notes that the event may be possibly due to the study drug, admitting disease, or treatment.

This result is a record of what was observed in this study group. It is not a comparison with MT alone, placebo, or another treatment, because none is reported. Without a control group, the event cannot be attributed to IA TNK based on this study alone. The same limitation applies to the adverse-event figures and deaths: they describe events recorded during the trial, but do not establish their cause or show how event frequency would compare under another approach.

The study also does not report a confidence interval, p-value, or comparative effect estimate in the registry record. Consequently, the precision of the outcome estimate and any statistical evidence for a difference between strategies are not available. The count should not be generalized as a precise risk estimate for other participants or settings.

The findings do not demonstrate that IA TNK is effective, ineffective, safe, or unsafe. They also do not rule out uncommon outcomes or establish how the intervention compares with care without IA TNK. The pilot can inform questions for further study, but such questions require a design and analysis capable of making a valid comparison. Any sample-size illustrations based on assumed two-arm comparisons are planning tools, not an estimate of this trial’s observed power.

14. Why This Trial Matters Statistically

This trial matters statistically because it illustrates the distinction between documenting outcomes and estimating a treatment effect. A prospective pilot can record whether an intervention was given after a specified procedural result and describe events within a defined timeframe. Those observations can be useful in characterizing the experience of a treated group. But a single-group design cannot separate the intervention’s contribution from the influence of the underlying stroke, thrombectomy, or other treatment and care.

The primary outcome combines an imaging-defined hemorrhage criterion with neurologic worsening. Such endpoints can capture more than one aspect of an early safety concern, but interpretation depends on clear component-level reporting. The registry gives an overall event description that includes one participant with PH-1 subarachnoid hemorrhage; it does not separately quantify the endpoint components. That makes it important to distinguish the stated endpoint definition from the detail actually available about its result.

The record also highlights why event attribution and comparative evidence are different questions. The registry explicitly leaves open whether the reported hemorrhage was related to the study drug, admitting disease, or treatment. A descriptive event count cannot resolve that uncertainty. A concurrent comparison and prespecified analysis would be needed to estimate differences between treatment strategies, with appropriate attention to uncertainty.

Finally, registry entries can identify important gaps in reporting, including analysis methods, missing-data handling, and multiplicity plans. Those gaps do not erase the observations that are recorded, but they constrain what can be inferred from them. In this pilot, the main statistical contribution is descriptive: it records early outcomes and safety experience after adjunctive IA TNK, while leaving comparative effectiveness and causal safety questions unanswered.

15. 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 most consequential limitation is the single-group, non-randomized design. There is no concurrent control arm, so the registry cannot support a like-for-like estimate of outcomes with IA TNK versus outcomes without it. The report’s own wording about the possible cause of the PH-1 subarachnoid hemorrhage underscores that attribution remains uncertain.

The registry reports enrollment of 20 and includes 20 participants in the primary outcome analysis. A pilot of this size provides limited information about less common outcomes and the precision of event estimates. The record does not provide a confidence interval for the primary result or a formal precision target. It also does not report the sample-size rationale, so the intended scope of inference cannot be assessed from the registry.

The primary endpoint description does not separately report the count for each component. While the record gives the event definition and reports one participant with PH-1 subarachnoid hemorrhage, it does not provide a component-level breakdown or a separate account of neurologic worsening. That restricts interpretation of the composite outcome.

Other limitations include the absence of reported analysis records and a detailed statistical analysis plan. The registry does not report methods for missing data, analysis-population rules beyond the primary outcome population, multiplicity handling, or the causes and treatment relationships of deaths. The study is described as single-center, which also limits the extent to which its descriptive experience represents other settings. These limitations are specific to the information recorded and should not be filled by assumptions about the protocol or conduct.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial — NCT05172934.
• Registry record last updated 2026-08-06; status last verified 2026-04.
• Results first posted 2026-08-06.
• 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.

19. Record Summary

NCT05172934 is a completed phase 2, prospective, single-center, non-randomized pilot study of intra-arterial tenecteplase after standard-of-care mechanical thrombectomy in participants with ischemic stroke. Participants received IA TNK after achieving mTICI 2b or 2c reperfusion. The registry reports enrollment of 20 and follow-up for 3 months after treatment.

The primary outcome concerns intracranial hemorrhage and neurologic worsening of at least 4 NIHSS points within 24 hours (+/- 8 hours), assessed under ECASS-II criteria. The record states that 20 participants were included in the primary outcome analysis and reports one participant with PH-1 subarachnoid hemorrhage, with possible attribution to the study drug, admitting disease, or treatment. Safety listings include serious and other adverse events and 3 deaths, without a control group or reported causal attribution.

The record lists secondary outcomes but no analysis records. It does not report comparative effect estimates, confidence intervals, statistical tests, missing-data methods, or a detailed statistical analysis plan. The results are therefore descriptive and cannot establish comparative benefit or harm.