This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction (NCT02312856), a na na study. The primary outcome is Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02312856 |
| Phase | NA |
| Condition | Intracranial Aneurysms |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pulsar Vascular |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled participants undergoing treatment for bifurcation basilar or carotid terminus aneurysms. The condition is listed as intracranial aneurysms. One enrolled participant had MRA rather than angiography and was excluded from Raymond Score analysis.
Intervention
The intervention was PulseRider, listed as a device. The arm description refers to endovascular treatment of intracranial aneurysms.
Comparator
The record describes a single-group study. It does not report a separate comparison group, so the clinical question is not a randomized comparison of PulseRider with another treatment or with no device.
Primary question
At 180 days post procedure, how many participants achieved Raymond Score I or II, or experienced neurological death? The outcome title joins these events, while the description distinguishes aneurysm occlusion from death and stroke.
The registry summary says the study was designed to evaluate PulseRider safety in participants undergoing treatment for bifurcation basilar or carotid terminus aneurysms. The listed primary outcome also includes an angiographic measure of aneurysm occlusion. These are different clinical concepts: Raymond Score grades the degree of occlusion, whereas death is a safety outcome. The record does not explain how the two elements in the outcome title were combined into an analysis rule, or how stroke was handled in the endpoint calculation. The question that can be stated from the record is therefore limited to the outcome wording and its 180-day timeframe; the actual result and its analytic definition are not reported in the registry record.
3. Trial Design
The record identifies this as a completed, single-group study of PulseRider, a device used in endovascular treatment of intracranial aneurysms. It lists an enrollment of 34 and no separate comparator group. Allocation and phase are listed as NA, and masking is listed as none. The sponsor is Pulsar Vascular. The recorded start date is 2014-10-31, and the primary completion date is 2015-10-13.
The clinical focus was safety in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms. The intervention arm is described as endovascular treatment of intracranial aneurysms. Because the study is single-group, the record does not support a like-for-like comparison against another intervention. It also does not report a randomized allocation process or masking of participants or investigators.
The record lists one outcome measure and no analysis entries. It does not report a protocol, statistical analysis plan, sample-size justification for the trial, interim analyses, or a comparison strategy. Those design details should not be inferred from the completion status or the listed enrollment. A planning illustration based on an observed effect is not evidence that the study was designed around that effect, and it does not turn this single-group study into a two-arm comparison.
The Raymond Score analysis had a specific population qualification: one enrolled participant had MRA performed instead of an angiogram and was excluded from that analysis. The record does not report further details about the analysis population, handling of other missing measurements, or whether all enrolled participants contributed to each safety summary.
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
| Stage | PulseRider |
|---|---|
| STARTED | 34 |
| COMPLETED | 30 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | PulseRider |
|---|---|
| Death | 1 |
| Lost to Follow-up | 3 |
Analysis population for the primary outcome, as defined in the registry: One enrolled participant had MRA performed instead of an angiogram and is excluded from Raymond Score analysis.
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: Male and female subjects, ≥18 years of age with a wide neck (≥ 4 mm or dome to neck ratio \< 2) basilar or carotid terminus aneurysm located at a bifurcation. Subjects with acutely ruptured aneurysms were excluded from the study. The aneurysm parent vessel measurements were required to be between 2.7 mm and 4.5 mm to be suitable for the procedure.
| Characteristic | Unit | PulseRider |
|---|---|---|
| Participants analysed | 34 | |
| Age, Continuous: Age | year | 60.9 (SD 13.4) |
| Sex: Female, Male: Female | Participants | 29 |
| Sex: Female, Male: Male | Participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death, measured over 180 days post procedure.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled as the number of participants who achieved Raymond Score I or II or experienced neurological death, with assessment at 180 days post procedure. The record describes the Raymond Scale as an angiographic classification for grading occlusion of endovascularly treated intracranial aneurysms. Score I means complete obliteration; Score II means residual neck. Score III means residual aneurysm, with IIIa describing contrast opacification within coil interstices and IIIb describing opacification outside the coil interstices along the residual aneurysm wall.
The scale is used to describe the angiographic result of aneurysm treatment. The record notes that Raymond I is typically associated with better outcomes, but the score itself assesses occlusion and is not a measure of death. The description says the primary outcome looked at safety, including death or stroke, and aneurysm occlusion, while also stating that these are different outcomes. This distinction matters: an occlusion grade and a safety event do not represent the same kind of clinical result.
The title’s use of “or” appears to join the occlusion category and neurological death, but the registry record does not report the precise analysis rule for that combination. It also does not report the number achieving each category or the number experiencing neurological death under this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes that 34 participants were enrolled in a single-group study of PulseRider and that the primary outcome was intended for assessment 180 days post procedure. It does not report a primary-outcome count, an effect estimate, a confidence interval, or a statistical test. The record lists one outcome measure but no analysis entries. Consequently, the posted registry information does not show how many participants met the stated outcome or how precisely any estimated rate was measured.
The outcome wording requires caution. Raymond Score I or II represents an angiographic occlusion category, whereas neurological death is a safety event. The outcome description also mentions death or stroke as safety outcomes and says that safety and occlusion are different. The registry record does not report a detailed rule explaining how these elements were combined, whether they were analyzed separately, or how the stroke component was incorporated. Without that definition and the outcome counts, a numerical interpretation of the primary endpoint is not possible.
The adverse-event summary lists 12 participants affected by serious adverse events among 34 at risk and 27 affected by other adverse events among 34 at risk. These are descriptive counts in a single group, not a comparison with a control group. The serious-event terms include Stroke at 14.7% and Death at 2.9%, among other listed terms. The group summary separately lists 0 deaths. The registry record does not explain the apparent difference between the serious-event term for Death and the group-level death count, so those entries should be reported as recorded rather than reconciled by assumption.
These observations describe events recorded in the registry; they do not establish whether an event was caused by the device or procedure. A single-group record cannot distinguish the observed event experience from what would have occurred under a different treatment. The listed counts also do not, by themselves, establish comparative effectiveness, safety relative to an alternative, or the size of a treatment effect.
In general, a confidence interval communicates the range of values reasonably compatible with an estimate under the analysis assumptions. No interval for the primary outcome is reported in the registry record. In its absence, the precision of the primary-outcome estimate cannot be judged from these entries. The completion status indicates that the study is recorded as completed; it does not supply missing outcome results or analytical details.
9. Statistical Methods Explained
The primary outcome is a binary participant-level outcome as described in the record: participants are counted according to whether the stated event criterion is met. The registry lists the outcome parameter as a number of participants. It does not provide the observed number meeting the criterion or an analysis entry. A count alone, even when available, would not convey precision unless paired with an appropriate denominator and uncertainty estimate.
In general, binary outcomes distinguish whether an event occurred for each participant, rather than measuring a continuous quantity such as a laboratory value. A proportion or rate can be estimated from a participant count and a defined analysis population. Such an estimate should be accompanied by information about uncertainty, commonly a confidence interval. No primary-outcome estimate, denominator for that endpoint, or confidence interval is reported in the registry record. The enrollment count should not be treated as the analysis denominator without confirmation that all enrolled participants were included in that outcome analysis.
The Raymond Score is an ordered angiographic classification, with the record describing classes I, II, and III and subcategories IIIa and IIIb. The primary title groups I and II together, but the record does not report the number in either class or the analytic handling of the combined category. One participant had MRA rather than an angiogram and is specifically excluded from Raymond Score analysis. The record does not describe how that participant was handled for the rest of the primary outcome or whether other measurements were unavailable.
In general, a confidence interval for a binary outcome reflects both the observed result and the amount of information available. An interval is useful because the point estimate alone can conceal substantial uncertainty. The record has no reported primary-outcome interval, and no statistical test or model is listed. Therefore, there is no reported inferential result from which to discuss statistical significance, precision, or compatibility with a particular benchmark.
The sample-size assumptions associated with planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. The assumptions specify total events for time-to-event illustrations using Schoenfeld and participants per arm for other illustrations. These are planning calculations based on an observed effect, not the trial’s own design. In particular, the registry describes a single-group study, so the equal-allocation, two-arm setup is not a description of its enrolled design. Such illustrations do not represent observed power. The record does not report the trial’s own sample-size justification or design assumptions.
In general, a planning calculation estimates the amount of information a future study might need under chosen assumptions. It depends on the target effect, significance level, allocation, outcome type, and analysis method. When the target is expressed as a fraction of an observed effect, it is a hypothetical planning target, not evidence that the original study was powered to detect it. The record does not provide the primary endpoint result needed to assess the relation between a planning target and the observed outcome.
Over-dispersion is a general concern when the variability in observed counts exceeds what a model assumes. If present, it can make standard errors too small and confidence intervals too narrow unless the analysis accounts for it. The primary outcome is recorded as a binary participant count, but no model or dispersion estimate is reported. It would therefore be inappropriate to claim that over-dispersion was tested, found, or handled in this study.
Multiplicity is a general issue when several outcomes, time points, or subgroup tests are examined: repeated testing can increase the chance of at least one apparently notable result. The registry record lists one outcome measure, but does not report a statistical analysis plan, a testing hierarchy, or any multiplicity adjustment. The number of outcome measures listed does not establish how many analyses were planned or performed. No conclusion about multiplicity control can be drawn from the record.
Finally, the distinction between an outcome definition and an outcome result is important. The registry describes what the primary measure was intended to capture and provides a timeframe, but it does not report a result or analysis. General statistical methods can explain what an estimate, confidence interval, or planning calculation means; they cannot fill in those unreported values or resolve the endpoint’s unspecified combination rule.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure and no analysis entries. It does not report a statistical analysis plan, a hierarchy of outcomes, interim analyses, or a multiplicity adjustment. The listing of one measure does not establish that only one analysis was planned or conducted, and there is not enough information to determine how multiple outcomes, time points, or subgroup analyses were handled.
For the Raymond Score analysis, the record states that one enrolled participant had MRA rather than an angiogram and was excluded. It does not report the resulting analysis denominator, the participant’s handling in any combined endpoint, or whether other primary-outcome data were missing. The record also does not describe an imputation method, a sensitivity analysis, or a missing-data assumption. These details are not reported in the registry record.
The registry identifies enrollment of 34 and provides safety counts, but those entries do not establish that every enrolled participant was included in each analysis. The record does not define a full analysis population, a per-protocol population, or another analysis population. It is therefore not possible to determine whether the reported safety summaries and the Raymond Score outcome used the same participants.
In general, missing-data methods matter because exclusions or unavailable measurements can affect both the estimated outcome and its uncertainty. The extent of that effect depends on why data are missing and how the analysis handles them. The record does not provide enough information to assess those issues beyond the stated MRA-related exclusion from Raymond Score analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Number | 12 | 34 | 35.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Number | 0 of 34 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2.9% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Number | 27 of 34 |
Most frequent serious adverse event terms
| Event term | Organ system | Number |
|---|---|---|
| Stroke | Cardiac disorders | 5 of 34 |
| Death | Cardiac disorders | 1 of 34 |
| Cauda Equina Syndrome | Nervous system disorders | 1 of 34 |
| Coil perforation of aneurysm | Surgical and medical procedures | 1 of 34 |
| Anemia | Blood and lymphatic system disorders | 1 of 34 |
| Possible seizure | Nervous system disorders | 1 of 34 |
| Leg Fracture | Musculoskeletal and connective tissue disorders | 1 of 34 |
| Weakness | Musculoskeletal and connective tissue disorders | 1 of 34 |
| Femoral Occlusion | Vascular disorders | 1 of 34 |
| Hypotension | Blood and lymphatic system disorders | 1 of 34 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Number |
|---|---|---|
| Headache | Vascular disorders | 10 of 34 |
| Respiratory problems | Respiratory, thoracic and mediastinal disorders | 7 of 34 |
| Nausea | General disorders | 4 of 34 |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | 3 of 34 |
| Depression | Psychiatric disorders | 2 of 34 |
| Constipation | General disorders | 2 of 34 |
| Ecchymosis | General disorders | 2 of 34 |
| Hematoma | General disorders | 2 of 34 |
| Urinary Tract Infection | Infections and infestations | 2 of 34 |
| Itching | Skin and subcutaneous tissue disorders | 1 of 34 |
Serious events with the highest arm-level rate: stroke (14.7%), death (2.9%), cauda equina syndrome (2.9%), coil perforation of aneurysm (2.9%), anemia (2.9%).
The safety summary lists 12 participants with serious adverse events among 34 at risk, and 27 participants with other adverse events among 34 at risk. These are participant counts in a single-group study, not rates compared with a control group. The serious-event terms listed include Stroke at 14.7%, Death at 2.9%, Cauda Equina Syndrome at 2.9%, Coil perforation of aneurysm at 2.9%, Anemia at 2.9%, and Possible seizure at 2.9%.
The group summary also lists 0 deaths. The registry record does not explain how that entry relates to the serious-event term Death at 2.9%. It is not appropriate to reconcile the two entries by assuming they refer to the same definition, reporting period, or participant set; those details are not reported in the registry record.
In general, an adverse event recorded during a study is not, by itself, evidence that the intervention caused it. The registry record does not report a comparison group or provide an attribution analysis for these terms. The counts describe events recorded in the study group; they should not be read as estimates of excess risk or as comparative safety effects.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed, single-group study of PulseRider in endovascular treatment of intracranial aneurysms, with an enrollment of 34. It identifies a primary outcome at 180 days post procedure and provides a description of the Raymond Scale. It also provides safety-event counts. These details describe the study’s stated focus and selected recorded information.
The record does not report the primary-outcome result, a confidence interval, a statistical test, or an analysis entry. It therefore does not establish the number of participants who achieved Raymond Score I or II, the number who experienced neurological death under the endpoint definition, or the precision of an estimated outcome rate. The endpoint wording combines an occlusion category with neurological death, while the description distinguishes occlusion from safety outcomes; the record does not report the rule that connects them.
The serious and other adverse-event counts are descriptive summaries, not comparisons. With no separate control group, they cannot show how the observed event experience differs from an alternative treatment or from no treatment. The record does not report causal attribution for listed adverse events, so the event counts alone do not establish that PulseRider caused any particular event.
In general, statistical evidence is most interpretable when the outcome definition, analysis population, estimate, and uncertainty are all available. A study’s completion status does not substitute for those results. The information in the registry can identify what was studied and which safety events were listed, but it cannot answer comparative questions or support a conclusion about the magnitude or precision of the primary outcome.
13. Why This Trial Matters Statistically
This study raises several statistical issues that are common in device evaluations. First, the record is single-group, so its outcome and safety counts are descriptive rather than comparative. Without a control group, observed events cannot be separated statistically from the event experience that might have occurred under another treatment or under different conditions. This limits the kinds of conclusions the design can support.
Second, the primary outcome joins two clinically distinct types of information: angiographic occlusion and neurological death. The record explains that Raymond Score measures aneurysm occlusion and is not used to assess death. An analysis needs a clear operational definition for combining such components. The registry record does not report that rule, so the outcome cannot be interpreted as a fully specified composite from the description alone.
Third, the record illustrates why a result needs more than an outcome label and an enrollment count. A primary estimate, a clearly defined analysis population, and an uncertainty measure would be needed to understand the observed result and its precision. Those primary-outcome results are not reported in the registry record. The stated exclusion of one participant from Raymond Score analysis also underscores the importance of knowing which participants contributed to each outcome.
Finally, planning calculations should not be confused with evidence from the enrolled study. The assumptions describe two-arm planning illustrations, whereas the registry identifies a single-group design. Such calculations may illustrate how planning depends on assumptions, but they do not establish the trial’s original design or observed power. Together, these points show why registry descriptions, outcome definitions, analysis details, and results need to be read separately.
14. 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 principal limitation for statistical interpretation is that the registry record does not report a primary-outcome count, estimate, confidence interval, or analysis. Although the record identifies a 180-day timeframe and describes the Raymond Scale, the result for the stated endpoint cannot be assessed. The endpoint title also combines Raymond Score I or II with neurological death, while the description says that occlusion and safety outcomes are different. The method for combining them is not reported.
The single-group design has no like-for-like control comparison. Consequently, the adverse-event counts cannot establish comparative safety or attribute events to PulseRider. The record lists 12 participants with serious adverse events and 27 with other adverse events, but does not report a control-group experience or event-attribution analysis.
The analysis population is not fully described. One participant with MRA instead of angiography was excluded from Raymond Score analysis, but the record does not report the resulting denominator or how this participant contributed to the rest of the endpoint. The handling of any other missing measurements is not reported in the registry record.
The serious-event list includes Death at 2.9%, while the group summary lists 0 deaths. The record does not explain this difference. In addition, the statistical plan, sample-size justification, interim analyses, and multiplicity approach are not reported. The planning assumptions described for illustrations do not establish the study’s own design calculations. These limitations prevent a complete assessment of the primary result, its precision, and the analytic choices behind it.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction — NCT02312856.
- Registry record last updated 2019-04-17; status last verified 2019-04.
- Results first posted 2019-03-26.
- 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.
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18. Record Summary
This completed, single-group study evaluated PulseRider in endovascular treatment of intracranial aneurysms. The registry lists an enrollment of 34, no masking, and a primary outcome assessed 180 days post procedure. One participant who had MRA rather than angiography was excluded from Raymond Score analysis.
The outcome title refers to Raymond Score I or II or neurological death. The description distinguishes aneurysm occlusion from safety outcomes, but the rule for combining them is not reported. The registry lists one outcome measure and no analysis entries, and does not report the primary-outcome result or its precision.
The safety summary lists 12 participants with serious adverse events and 27 with other adverse events among 34 at risk, along with serious-event terms and percentages. The group summary lists 0 deaths, while Death also appears as a serious-event term at 2.9%; the record does not explain the difference. No comparator is reported, so the safety counts are descriptive rather than comparative.