First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism (NCT03927508), a na phase 1 study. The primary outcome is Safety: Number of Participants With Major Bleeding Events.

2. Clinical Question

3. Trial Design

This was a phase 1, first-in-man study of the Bashir™ Endovascular Catheter for acute pulmonary embolism. The registry lists a single group, BEC Treatment, and an enrollment of 9. The study status is completed. Its recorded start date is 2019-03-14, and its primary completion date is 2019-12-19.

The device is described as intended for localized infusion of therapeutic agents into the pulmonary artery. The arm description specifies localized infusion into the pulmonary artery, while the intervention listing names both the device and r-tPA. The primary endpoint's observation window is tied to initiation of r-tPA administration.

The record lists allocation as NA and masking as none. This was not a randomized comparison: there is no control group against which to compare outcomes. Consequently, the study can describe events recorded among participants in the treatment group, but it cannot provide a like-for-like estimate of how those outcomes compare with a different treatment or with no treatment.

The registry lists one outcome measure and no analyses. It does not report a sample-size justification, a statistical analysis plan, interim analyses, or analysis-population definitions. The sample-size illustrations associated with the record are planning scenarios, not the study's own design justification or evidence of observed power. Their assumptions do not change the underlying single-group design.

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 Safety: Number of Participants With Major Bleeding Events, measured over Within 72 hours of initiation of r-tPA administration..

The primary endpoint is the number of participants with major bleeding events, with participants as the unit. It concerns events occurring within 72 hours of initiation of r-tPA administration. The registry defines major bleeding using International Society of Thrombosis and Hemostasis criteria for non-surgical patients: fatal bleeding; symptomatic bleeding in a critical area or organ, including intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial bleeding, or intramuscular bleeding with compartment syndrome; or bleeding causing a fall in hemoglobin of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.

Counting affected participants makes the endpoint a participant-level binary outcome: each participant is classified according to whether the specified event occurred during the observation window. This differs from counting every event, since a participant-level count does not indicate how many episodes an affected participant experienced.

In general, a safety endpoint of this kind is used to characterize serious harm observed during a defined period after treatment begins. The timeframe makes the period of observation explicit, while the definition gives a consistent rule for classifying events. The endpoint's purpose is not to establish a comparative treatment effect in a single-group study. The primary endpoint result itself is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

The primary outcome is a count of participants who meet a defined event criterion, not a total count of bleeding episodes. In general, a participant-level binary outcome records whether each person had the event during the specified observation window. This keeps the unit of analysis clear: repeated events in one participant are not automatically equivalent to events in separate participants.

The registry specifies the event definition and the window, which are essential parts of interpreting a safety endpoint. A major bleed is defined using the listed International Society of Thrombosis and Hemostasis criteria, and the relevant period begins at initiation of r-tPA administration and lasts through the stated 72-hour timeframe. The primary endpoint result is not reported in the registry record, so no participant count can be interpreted for this endpoint.

Why does the design matter?

This is a single-group study, not a randomized comparison. In general, a single-group count can describe the experience recorded in the treated group, but it does not estimate a comparative effect. Without a control group, the outcome under the study intervention cannot be directly contrasted with an outcome under an alternative. Differences that might otherwise be attributed to treatment cannot be separated from other differences between groups, because there is no second group in the design.

The record lists allocation as NA and masking as none. These design details matter when judging how outcomes could be affected by assignment or by knowledge of treatment. The record does not describe further procedures for outcome assessment, so no additional safeguards or methods should be inferred.

What can a confidence interval tell a reader?

In general, a confidence interval expresses statistical uncertainty around an estimate. A narrower interval indicates greater precision under the model and assumptions used; a wider interval indicates more uncertainty. Intervals do not correct for limitations in study design, measurement, or missing data. The registry does not report a confidence interval for the primary endpoint, and it reports no analyses. Therefore the precision of a primary endpoint estimate cannot be evaluated from the posted record.

Likewise, a p-value would address compatibility between data and a specified statistical model under a null hypothesis; it would not establish clinical importance or prove causation. No p-value or inferential analysis is reported for the primary endpoint. There is consequently no basis in the registry record for describing the primary safety result as statistically significant or not statistically significant.

What do the planning illustrations mean?

In general, sample-size calculations are forward-looking planning tools. They describe the number of participants a hypothetical design might require under specified assumptions about effect size, significance level, allocation, and statistical method. The record's illustrations are explicitly planning scenarios based on a fraction of the observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. They are not the study's own sample-size justification, and they do not indicate the power actually achieved by this single-group study.

The record states that the illustrations give participants per arm except for time-to-event calculations, which give total events. That convention concerns the interpretation of the planning scenarios; it does not turn this study into a two-arm trial. Since the study has one group and no reported primary endpoint analysis, the illustrations should not be used as evidence that the study had adequate power or that an effect was detected.

Why can over-dispersion matter?

In general, over-dispersion occurs when outcome variability is greater than a statistical model expects. It can make standard errors too small if the model assumes less variability than the data contain, which in turn can make uncertainty appear lower than it is. The registry record does not report a model-based analysis or an over-dispersion assessment. This concept is therefore general background, not a claim about a method used in this study.

For a binary participant-level endpoint, the key descriptive elements would ordinarily include the number assessed, the number meeting the event definition, and an uncertainty estimate if an analysis is reported. The registry supplies the endpoint definition and the enrollment count, but not the primary outcome count or an inferential analysis. No recalculated estimate should be substituted for the absent sponsor analysis; there is no posted primary endpoint analysis to recalculate.

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("BEC Treatment")
n      <- c(9)
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  BEC Treatment  9  1  11.1  0.3  48.2  2.0  43.5  2.5  44.5

11. Multiplicity, Missing Data and Analysis Populations

Multiplicity concerns the risk of misleading statistical conclusions when several hypotheses or outcomes are tested. In general, if many tests are conducted, a prespecified approach may be needed to interpret them jointly. The registry lists one outcome measure and no analyses. It does not report a multiplicity strategy, a hierarchy of outcomes, or whether additional outcomes were tested. With no analyses reported, the record does not permit evaluation of how multiple testing was handled.

Missing-data methods are also not reported in the registry record. The enrollment count is 9, but the record does not state how many participants contributed data to the primary endpoint, whether any endpoint observations were unavailable, or how missing observations would be handled. It is therefore not possible to determine whether the primary endpoint count reflects all enrolled participants.

Analysis populations are not described. The record does not say whether the analysis included all enrolled participants, only participants who received the intervention, or another defined group. Such definitions matter because they explain who contributes to an outcome estimate and how departures from the intended treatment are handled. No population definition should be assumed from the enrollment figure alone.

These reporting gaps are distinct from the adverse-event summary, which lists participants at risk and participants affected for its categories. That summary does not supply the missing primary endpoint result or analysis-population rules. The registry record also does not report interim analyses or a statistical analysis plan, so neither should be inferred.

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: hematoma (11.1%).

The adverse-event summary lists 1 participant with serious adverse events and 4 participants with other adverse events in the BEC Treatment group. It lists 9 participants at risk for each category and 0 deaths. Hematoma appears among the top serious terms, with 11.1%. These values describe the adverse-event summary and should be kept distinct from the primary endpoint, which counts participants with major bleeding according to a specified definition and timeframe.

A serious adverse event is not automatically the same as a major bleeding event. The endpoint requires the stated bleeding criteria and occurrence within 72 hours of initiation of r-tPA administration. The registry does not report the primary endpoint count, nor does it state that the serious adverse event count or the hematoma term corresponds to participants who met that endpoint definition.

In general, adverse-event summaries are descriptive. They do not by themselves establish that an event was caused by a device or drug. The record does not report causal attribution in the posted summary. The figures should therefore be read as recorded event information, not as a comparative estimate of safety or proof of causation.

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

The registry record documents a phase 1, first-in-man, single-group study of the Bashir™ Endovascular Catheter in acute pulmonary embolism. It identifies the intended device use, names r-tPA, and defines a primary safety endpoint focused on major bleeding within 72 hours of initiation of r-tPA administration. It also reports adverse-event summary counts for the BEC Treatment group.

The record does not report the primary endpoint result. That omission means it is not possible to say how many participants met the major-bleeding definition, or to assess the precision of that endpoint estimate. The adverse-event summary cannot fill this gap because serious adverse events and the defined major-bleeding endpoint are not necessarily the same classification. In particular, the listed hematoma term is not shown to meet the endpoint criteria.

The study's single-group design also determines what its data can mean. In general, outcomes from one treated group can be described, but they cannot establish a comparison with an alternative treatment or isolate the contribution of the device from r-tPA and other influences. No control group is listed, and no comparative treatment effect is reported.

The record does not report a statistical analysis plan, analysis populations, missing-data methods, or interim analyses. These gaps limit assessment of how the endpoint was analyzed and who contributed to the analysis. The sample-size illustrations are planning scenarios and are not observed power. Overall, the record gives a design and an adverse-event snapshot, but it does not provide a reported result for the primary safety question or the comparative evidence needed to draw a treatment-effect conclusion.

14. Why This Trial Matters Statistically

First-in-man device studies raise an important statistical challenge: the initial clinical experience may be useful for describing feasibility and safety events, while the amount of information available for estimating event rates is limited. This study enrolled 9 participants in a single group. The small enrollment makes clear why event counts and their uncertainty need to be interpreted carefully, but the record does not provide a primary endpoint count or an interval estimate.

The endpoint definition is statistically important because safety counts depend on consistent event classification. The registry specifies the major-bleeding criteria and the observation window, making the intended outcome explicit. Yet a definition alone is not a result: the count of participants meeting that definition is not reported in the registry record. This distinction is central to reading registry results responsibly.

The study also illustrates the difference between descriptive safety summaries and comparative evidence. Adverse-event counts can describe what was recorded in the treated group, while a single-group design cannot estimate how those counts differ from a comparator. The device and r-tPA are both part of the intervention context, so the record cannot isolate their separate contributions to outcomes.

Finally, the planning illustrations should not be confused with evidence about the study's achieved power. They are hypothetical calculations using stated assumptions, whereas the registry reports no primary endpoint analysis. Keeping planning assumptions, observed counts, and inferential conclusions separate is an important statistical discipline in interpreting early device studies.

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 direct limitation is that the primary endpoint result is not reported in the registry record. The endpoint is defined, but without its participant count there is no reported primary safety outcome to interpret. The registry lists no analyses, so there is no associated estimate, confidence interval, or inferential result for that endpoint.

The study is single-group and has no randomized comparator. Therefore, even if event counts are described, they cannot establish a difference from another treatment or identify the effect attributable to the catheter alone. The intervention listing includes r-tPA, which further means the registry's design does not separate device-related outcomes from outcomes associated with the accompanying treatment context.

The adverse-event summary is not a substitute for the primary endpoint. It reports serious and other adverse-event counts and lists Hematoma at 11.1% among top serious terms, but it does not establish that those events meet the primary endpoint definition. Causal attribution is not reported in the adverse-event summary.

Additional methodological details are not reported in the registry record: the sample-size justification, statistical analysis plan, interim analyses, missing-data handling, and analysis populations. These omissions limit assessment of how outcomes were selected, analyzed, and handled when data were unavailable. The planning illustrations are not a substitute for these design details and do not represent observed power. The record should consequently be interpreted as a limited descriptive account rather than a complete statistical report of the primary safety outcome.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism — NCT03927508.
• Registry record last updated 2023-03-30; status last verified 2023-03.
• Results first posted 2023-03-30.
• 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

This completed phase 1 study, NCT03927508, assessed the Bashir™ Endovascular Catheter in acute pulmonary embolism. It was a first-in-man, single-group study with 9 participants enrolled. The registry records a start date of 2019-03-14 and a primary completion date of 2019-12-19.

The primary endpoint was the number of participants with major bleeding within 72 hours of initiation of r-tPA administration, using the stated International Society of Thrombosis and Hemostasis criteria. The primary endpoint result is not reported in the registry record, and the record lists no analyses.

The separate adverse-event summary lists 1 participant with serious adverse events, 4 with other adverse events, 0 deaths, and Hematoma at 11.1% among top serious terms. These descriptive figures do not establish the primary endpoint count or a comparative treatment effect. A sample-size justification, statistical analysis plan, missing-data methods, and analysis populations are not reported in the registry record.