LiquID Guide Catheter Extension Safety Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for LiquID Guide Catheter Extension Safety Study (NCT05406596), a na na study. The primary outcome is The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE).

2. Clinical Question

3. Trial Design

The LiquID Guide Catheter Extension Safety Study (NCT05406596) is listed as completed. Its start date is 2022-10-13, and its primary completion date is 2023-10-12. The registry lists an enrollment of 86, a single-group model, and no masking. The phase and allocation fields are listed as NA.

The brief summary characterizes the study as single arm, open label, historically controlled, and multicenter. The intervention is LiquID GCE Use, categorized as a device. No separate arm description is entered. While the summary uses the phrase “historically controlled,” the registry record does not identify a historical control group, describe how it was selected, or report outcomes for such a group. The available record therefore supports describing the study as a single-group device study, not as a direct comparison with a concurrent control.

The primary outcome is a participant count for in-hospital MACE, with follow-up through 48 hours or discharge, whichever comes first. A secondary outcome is also listed: the number of participants with a device-oriented clinical outcome. The registry lists two outcome measures, but the outcome results and their statistical analyses are not reported in the registry record. The record also does not report the protocol’s planned statistical methods, sample-size justification, or any interim-analysis plan.

These design features matter to interpretation. An open-label, single-group study can describe events recorded among participants who received the device, but it cannot by itself isolate the device’s effect from other influences or establish a comparative difference. The historically controlled description does not change that limitation in the absence of defined comparator data.

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

Analysis population for the primary outcome, as defined in the registry: All participants were analyzed for any adverse events that may have occurred.

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: Participants who were successfully screened

6. Primary Endpoint

The registry lists the primary outcome as The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE), measured over 48 hours or discharge (whichever comes first).

The primary endpoint counts participants with in-hospital major adverse cardiac events (MACE) by 48 hours or discharge, whichever comes first. Its listed components include device-caused events—target vessel dissection, longitudinal stent deformation, and proximal collar stent stripping—as well as cardiac death, stroke, and peri-procedural myocardial infarction. The MI definition refers to participant symptoms, ECG changes and/or the SCAI definition if cardiac enzymes are available.

A composite endpoint brings specified events into one outcome measure. In general, this can provide a concise way to describe several clinically important types of events, but the combined count does not show how often each component occurred. Components can also differ in nature and severity, so interpretation depends on knowing the component-level results as well as the overall endpoint. Those primary endpoint results are not reported in the registry record.

The endpoint’s short in-hospital timeframe focuses on events during the specified period. It does not describe outcomes beyond that period. The registry says all participants were analyzed for any adverse events that may have occurred, but further details about endpoint ascertainment and handling of incomplete follow-up are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is the primary endpoint?

The primary endpoint is a binary participant-level outcome: each participant either meets the endpoint definition during the specified follow-up period or does not. A count of participants with an event is a natural descriptive summary for this type of outcome. To understand the frequency in a group, readers also need the relevant denominator and a clearly defined follow-up period. The registry specifies the endpoint timeframe as 48 hours or discharge, whichever comes first, and identifies all participants as the adverse-event analysis population. However, the primary endpoint count itself is not reported in the registry record.

General statistical explanation: a proportion summarizes how common an event is in a defined group, while a confidence interval conveys uncertainty around that estimate. The interval depends on the data and the statistical method. Without the primary endpoint count and its analysis, neither an event proportion nor its precision can be assessed from the record.

What can a single-group design estimate?

The study is listed as single group, with no masking, and its brief summary calls it open label and historically controlled. A single-group analysis can describe outcomes observed among participants in that group. It cannot, on its own, distinguish an intervention-related effect from other explanations for the observed outcomes. A comparative analysis would require a defined comparison group and comparable outcome information. Although the summary uses the term historically controlled, comparator details and comparator results are not reported in the registry record.

General statistical explanation: comparisons are most interpretable when groups and outcome definitions are sufficiently comparable. Historical comparisons can be affected by differences in participant selection, clinical practice, follow-up, and event ascertainment. The registry does not report information needed to assess these issues for this study. No adjusted comparison or unadjusted comparison is reported.

How should event counts be read?

The adverse-event record gives participant counts for serious and other adverse events, with 86 listed as at risk for each category. It also lists 0 deaths and several serious-event terms with percentages. These entries are descriptive. The registry does not report a statistical test or uncertainty interval for these figures, nor does it provide a complete breakdown of the primary MACE endpoint by component.

General statistical explanation: event data can be sparse, and estimates based on few events may be imprecise. An event count alone does not describe that uncertainty. In some analyses, over-dispersion—greater variability than a statistical model expects—can make standard errors too small if the model does not account for it. The registry record does not report a model or analysis that would allow assessment of over-dispersion, and this concept should not be mistaken for a finding about this study.

What statistical plan is available?

The registry record lists 0 analyses. A statistical analysis plan, the method used for the primary endpoint, any covariate adjustment, interim analyses, and a sample-size justification are not reported in the registry record. These omissions mean that readers cannot determine from the posted record whether a planned inferential procedure was used or how it handled the outcome data.

The site’s planning illustrations are not observed trial results. In general, sample-size calculations depend on assumptions about the event frequency or effect to detect, the significance level, allocation, and statistical method. The stated illustration assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. They are planning assumptions, not evidence that this single-group study had a particular power. Sample-size illustrations must not be interpreted as observed power or as a substitute for the missing endpoint estimate.

What does a missing analysis mean?

When a registry entry names an outcome but supplies no result or analysis, the appropriate statistical conclusion is that the result is unavailable in the registry record. It is not appropriate to infer an event count, assume that the endpoint was met by no participants, or infer a favorable or unfavorable result. For this study, that distinction is especially important because the primary endpoint is specified in detail while its observed result is not reported.

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("LiquID GCE Use")
n      <- c(86)
events <- c(2)
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  LiquID GCE Use  86  2  2.3  0.3  8.1  0.6  8.1  0.7  8.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and a secondary outcome, and reports two outcome measures in total. It does not provide outcome results or analyses for either measure. A statistical plan describing how the primary and secondary outcomes were analyzed, or whether any multiplicity adjustment was planned, is not reported in the registry record.

In general, multiplicity arises when several outcomes or statistical tests are considered. The more tests used to support a conclusion, the more important it is to know which outcome was primary and how the analysis addressed the possibility of chance findings. The registry identifies the primary endpoint, but that designation alone does not reveal the analysis plan or any adjustment procedure. No inference about such procedures can be made from the record.

The primary endpoint description says all participants were analyzed for any adverse events that may have occurred. That statement identifies an analysis population for adverse events, but it does not explain how missing outcome information, withdrawals, or incomplete follow-up were handled. The registry record does not report the number of participants with missing endpoint data, reasons for missingness, imputation methods, or sensitivity analyses. It also does not report a separate analysis population for the secondary outcome.

In general, missing data can affect both the estimated event frequency and its uncertainty, particularly if the reasons for missingness relate to participant outcomes. Without details about the extent and handling of missing data, readers cannot assess whether the available outcome information represents the intended analysis population. The reported adverse-event counts should therefore be read as the entries in the registry, not as proof that outcome ascertainment was complete for every participant.

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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: dissection (1.2%), dissection/mi (1.2%), chest pain (1.2%), palpitations, dizziness (1.2%).

The adverse-event record lists 4 participants affected by serious adverse events among 86 at risk, and 15 affected by other adverse events among 86 at risk. It lists 0 deaths. These are group-level descriptive entries. The record does not provide a causal assessment that would establish whether the device caused an event, and the counts should not be read as a comparative safety estimate.

Four serious-event terms are listed: Dissection, Dissection/MI, Chest Pain, and Palpitations, dizziness. Each is accompanied by a reported value of 1.2%. The registry does not provide further detail in this entry to establish how the terms relate to the participant-level serious-event count. Do not add the term percentages or treat them as mutually exclusive categories; the record does not report whether terms overlap.

The adverse-event figures are not a replacement for the primary endpoint result. The primary endpoint has a specific definition and follow-up period, while the safety listing is presented as adverse-event information. The record does not provide the primary MACE count, a confidence interval, or a comparator analysis. These figures describe reported safety entries, not proof of benefit or harm.

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

The registry record documents a completed, single-group, open-label study of LiquID Guide Catheter Extension use in participants with coronary artery disease. It specifies in-hospital MACE as the primary endpoint and gives its component events and follow-up timeframe. It also reports adverse-event counts, serious-event terms, and 0 deaths. These details help identify what was studied and what safety information the registry lists.

However, the record does not report the primary endpoint’s observed participant count or a statistical analysis of it. It does not report an effect estimate, confidence interval, or p-value for the primary endpoint. The record therefore cannot establish how frequently the primary outcome occurred or how precisely it was estimated.

The study’s single-group design does not provide a concurrent, like-for-like control comparison. The brief summary’s reference to historical control does not include comparator outcomes or details that would support a comparative estimate. Thus, the posted information cannot establish a difference between the device and a control, or attribute an outcome to device use.

These limits do not mean that the study contains no useful information. The endpoint definition, timeframe, study design, and adverse-event entries are relevant descriptive information. But a defined endpoint is not itself an endpoint result, and descriptive counts do not answer a comparative question. The appropriate interpretation is bounded by the outcomes and analyses actually reported in the registry record.

No conclusion about clinical effectiveness or overall safety can be drawn from the missing primary outcome analysis. The reported adverse-event figures should not be converted into a claim that the device works or does not work. They are registry entries that require context from complete outcome reporting and a suitable study design for the question being asked.

14. Why This Trial Matters Statistically

This study illustrates why outcome definitions and outcome results must be considered separately. The registry provides a detailed definition of in-hospital MACE, including device-related and cardiac events, yet does not report the primary endpoint count or its analysis. Readers can identify what the investigators intended to measure without being able to estimate the observed result.

It also illustrates the distinction between a within-group description and a comparative treatment effect. A single-group study can document events among participants who received a device. A historical-control description, without comparator definitions and results, does not supply the information needed to make a like-for-like comparison. This distinction is central when interpreting safety and performance claims.

The registry’s adverse-event entries show why counts require careful context. Counts describe recorded events or affected participants, but they do not by themselves establish causality, comparative risk, or precision. Component-level detail, follow-up completeness, and an analysis plan can all affect interpretation. Those details and the primary endpoint analysis are not reported in the registry record.

General statistical practice emphasizes transparent reporting of the analysis population, missing data, uncertainty, and prespecified outcomes. Such reporting allows readers to assess whether an estimate answers the stated question and how much uncertainty remains. This record names the primary and secondary outcomes, but does not report their results or analyses. Statistically, recognizing that boundary is as important as interpreting the descriptive safety entries that are available.

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 for interpretation is that the registry record does not report the observed primary MACE count or its analysis. It therefore provides no primary endpoint estimate or measure of its precision. The secondary outcome is named, but its result is also not reported in the registry record.

The study is listed as single group and unmasked. Although the brief summary calls it historically controlled, the record does not identify a comparator group or report comparator outcomes. This prevents a like-for-like treatment comparison and leaves the historical-control description unevaluable from the posted information.

The registry does not report detailed eligibility criteria, participant characteristics, endpoint ascertainment procedures, or a statistical analysis plan. A sample-size justification, interim-analysis plan, and methods for handling missing data are also not reported in the registry record. These gaps limit assessment of the target population, precision, and risk of bias.

The adverse-event entries are descriptive and do not establish causation. The record does not explain whether the listed serious-event terms overlap, or provide a complete component-level analysis for the primary endpoint. The reported adverse-event information should not be treated as a substitute for the missing primary outcome results or as a comparative safety estimate.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: LiquID Guide Catheter Extension Safety Study — NCT05406596.
• Registry record last updated 2024-05-23; status last verified 2024-04.
• Results first posted 2024-05-08.
• 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

NCT05406596, the LiquID Guide Catheter Extension Safety Study, is listed as completed. The registry reports an enrollment of 86, a single-group model, and no masking. The brief summary describes an open-label, historically controlled, multicenter study. The intervention is LiquID GCE Use, categorized as a device.

The primary endpoint is the number of participants with in-hospital MACE by 48 hours or discharge, whichever comes first. A device-oriented clinical outcome is listed as secondary. The primary endpoint definition and timeframe are reported, but endpoint results and analyses are not reported in the registry record.

The adverse-event entry lists 4 participants affected by serious events and 15 by other events, with 0 deaths. These figures are descriptive and do not provide a comparison with a control group. The record does not include the statistical plan or missing-data methods.