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 Proximal Protection With The Mo.Ma Device During Carotid Stenting (NCT00744523), a na na study. The primary outcome is Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00744523 |
| Phase | NA |
| Condition | Carotid Artery Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 262 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medtronic Endovascular |
| Results posted | Yes |
2. Clinical Question
Population
Patients at high surgical risk for carotid endarterectomy who undergo carotid artery stenting with cerebral protection using the Mo.Ma device. The record describes a roll-in population and a pivotal population; its ITT description is incomplete.
Intervention
The Mo.Ma cerebral protection device, described as a proximal flow blockage cerebral protection device used during carotid stenting.
Comparator
No separate comparator group is listed. The study is recorded as single-group, and allocation is listed as NA. The roll-in and pivotal groups are not like-for-like control arms.
Primary question
How many participants had one or more major adverse cardiac and cerebrovascular events, defined as myocardial infarction, stroke, or death, through 30 days after the procedure?
ARMOUR was intended to evaluate the safety and effectiveness of the Mo.Ma device in the context of carotid artery stenting for people at high surgical risk for carotid endarterectomy. Its primary endpoint focuses on whether participants experienced at least one event in a combined clinical outcome during the period after the procedure. The endpoint includes cardiac and cerebrovascular events as well as death.
The registry record does not describe a randomized comparison or another control group. Its single-group design therefore addresses the recorded outcome among participants treated within the study, rather than a direct contrast between the device and a different treatment or protection strategy. The registry lists 262 participants as the enrollment and identifies roll-in and pivotal groups in the adverse-event record. Those group labels do not establish a treatment comparison.
The registry record does not report the primary endpoint result. Consequently, it does not establish from the posted primary outcome whether, or how often, participants experienced MACCE through 30 days. The clinical question and the recorded outcome definition can be described, but the primary outcome findings cannot be interpreted from the information in the registry record.
3. Trial Design
ARMOUR is recorded as a completed, single-group study of the Mo.Ma cerebral protection device during carotid stenting. The registry lists 262 participants as the enrollment. The study objective concerns safety and effectiveness among patients at high surgical risk for carotid endarterectomy who undergo carotid artery stenting. Carotid artery disease is the listed condition.
The record identifies one device intervention, the Mo.Ma cerebral protection device. It does not list a separate control intervention. Allocation is recorded as NA, and the model is single-group. Masking is recorded as none. These design entries do not describe a randomized, blinded comparison. The record lists the study phase as NA rather than naming a phase.
The record distinguishes MO.MA Roll-In Cases from MO.MA Pivotal Subjects in its adverse-event data. The roll-in group has 37 participants at risk in those data, and the pivotal group has 225. These are group descriptions within the study, not independent treatment arms for estimating a comparative effect. The registry record does not provide enough detail to characterize how the roll-in phase related to the conduct or analysis of the pivotal participants.
The study start is recorded as 2007-09, primary completion as 2009-03, and status as completed. The registry lists seven outcome measures and one analysis. It names device success, technical success, procedural success, restenosis at 30 days, target lesion revascularization at 30 days, and access site adverse events as secondary outcomes. The primary endpoint is MACCE through 30 days after the procedure.
The registry record does not report a sample-size justification, detailed protocol, or full statistical analysis plan. The sample-size calculations associated with the posted results are planning illustrations, not a description of the design used to determine the study enrollment.
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.
Procedure
| Stage | MO.MA Roll-In Cases | MO.MA Pivotal Subjects |
|---|---|---|
| STARTED | 37 | 225 |
| COMPLETED | 37 | 225 |
| NOT COMPLETED | 0 | 0 |
30 Days After the Procedure
| Stage | MO.MA Roll-In Cases | MO.MA Pivotal Subjects |
|---|---|---|
| STARTED | 37 | 225 |
| COMPLETED | 37 | 220 |
| NOT COMPLETED | 0 | 5 |
Reasons for not completing this period:
| Reason | MO.MA Roll-In Cases | MO.MA Pivotal Subjects |
|---|---|---|
| Insufficient follow-up | 0 | 5 |
Analysis population for the primary outcome, as defined in the registry: Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent 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.
| Characteristic | Unit | MO.MA Roll-In Cases | MO.MA Pivotal Subjects | Total |
|---|---|---|---|---|
| Participants analysed | 37 | 225 | 262 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 | 37 | 43 |
| Age, Categorical: >=65 years | Participants | 31 | 188 | 219 |
| Age, Customized: < 80 years | participants | 26 | 160 | 186 |
| Age, Customized: >= 80 years | participants | 11 | 65 | 76 |
| Age, Continuous | years | 74.28 (SD 10.38) | 74.66 (SD 8.54) | 74.61 (SD 8.80) |
| Sex: Female, Male: Female | Participants | 12 | 75 | 87 |
| Sex: Female, Male: Male | Participants | 25 | 150 | 175 |
| Region of Enrollment: United States | participants | 37 | 147 | 184 |
| Region of Enrollment: Europe | participants | 0 | 78 | 78 |
| History of Diabetes: Yes | participants | 15 | 83 | 98 |
| History of Diabetes: No | participants | 21 | 141 | 162 |
| History of Diabetes: No Response | participants | 1 | 1 | 2 |
| History of Hypertension: Yes | participants | 32 | 196 | 228 |
| History of Hypertension: No | participants | 5 | 29 | 34 |
| Symptomatic [1]: Symptomatic | participants | 8 | 34 | 42 |
| Symptomatic [1]: Asymptomatic | participants | 29 | 191 | 220 |
6. Primary Endpoint
The registry lists the primary outcome as Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure., measured over Up to 30 days after the procedure was performed.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with one or more major adverse cardiac and cerebrovascular events through 30 days after the procedure. MACCE is defined in the registry as any myocardial infarction, stroke, or death through day 30 post-procedure. The unit is participants, and the parameter is a number rather than a time-to-event measure. A participant with more than one listed event still meets the endpoint definition as a participant with one or more events.
A combined endpoint can summarize several clinically important event types in a single outcome. It can capture whether participants experienced any event in the defined set during the specified follow-up period. Interpretation depends on the exact components and time window, both of which are stated in the registry record. The components are not interchangeable: a combined count alone would not show how many events were myocardial infarctions, strokes, or deaths unless component-specific results were also reported.
The registry record does not report the primary endpoint count or an estimate of its uncertainty. It also does not report component-specific primary endpoint results. The endpoint definition can therefore be explained, but the observed frequency and the contribution of each component are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a single-group study and identifies a 30-day MACCE endpoint, but the primary endpoint result is not reported in the registry record. There is therefore no posted primary outcome count to interpret, and no basis in this record for describing the observed frequency of MACCE. The record also does not report a confidence interval or another measure of uncertainty for that endpoint.
The adverse-event entries are separate from the primary endpoint result. They list serious adverse events and other adverse events for MO.MA Roll-In Cases and MO.MA Pivotal Subjects. In the roll-in group, 11 of 37 participants at risk are listed as affected by a serious adverse event, and 27 of 37 are listed as affected by other adverse events. In the pivotal group, 37 of 225 are listed as affected by a serious adverse event, and 132 of 225 by other adverse events. These are descriptive counts in groups that received the device; they do not estimate a difference against a control group.
Because the design is single-group, the registry record does not provide a randomized comparison that would separate outcomes associated with use of the device from outcomes that might occur under another strategy or from the underlying clinical context. The record also does not report details that would support adjustment for differences between the roll-in and pivotal groups. Their counts should not be read as a controlled contrast or as evidence of a trend between groups.
For a binary outcome such as whether a participant had at least one event, the count is meaningful only in relation to a clearly defined analysis population and denominator. The primary endpoint lists multiple population descriptions, including roll-in, pivotal, and ITT wording, but the ITT description is incomplete in the registry record. The primary result and the population used for any primary analysis are not reported in the registry record. This leaves uncertainty about which enrolled participants would contribute to a primary estimate.
The list of serious adverse-event terms includes hypotension at 18.9%, bradycardia at 2.7%, chronic obstructive pulmonary disease at 2.7%, confusional state at 2.7%, convulsion at 2.7%, and diverticular perforation at 2.7%. The registry record does not provide the denominators or additional detail needed to interpret how these term-level percentages were calculated, whether terms could overlap, or how events were attributed. The death entries are not reported in the registry record.
In general, a confidence interval communicates the range of values reasonably compatible with an estimate under the analysis assumptions. It is important because a count alone does not convey precision. No confidence interval for the primary outcome is reported in the registry record, so the precision of that endpoint cannot be assessed from the posted results. The same caution applies to interpreting percentages without a stated denominator or analysis method.
The record lists one analysis, but does not report the methods used for that analysis. It does not report an inferential test, adjustment strategy, handling of missing outcomes, or prespecified analysis plan. Accordingly, the posted information supports a description of the study structure and the adverse-event counts, but not a conclusion about comparative effect or a complete statistical assessment of the primary endpoint.
9. Statistical Methods Explained
The outcome information is primarily a participant count for a binary event definition: a participant either had one or more events meeting the endpoint definition during the stated follow-up period, or did not. A count is a direct description of how many participants met that definition. To interpret it fully, readers also need the analysis population, denominator, and a measure of uncertainty. The primary result, its denominator, and its uncertainty are not reported in the registry record.
What does a single-group design allow?
In general, a single-group study can describe outcomes among participants who received the intervention under study. It does not, by itself, supply an untreated or alternative-treatment outcome for comparison. A causal comparison ordinarily depends on a design and analysis that support a meaningful counterfactual contrast. Because the registry records this study as single-group and lists no separate comparator, the posted results do not support a treatment-effect estimate against another strategy.
The roll-in and pivotal labels identify groups in the adverse-event record, but the record does not identify them as randomized treatment groups. Comparing counts across these groups would not replace a control comparison. Group membership may reflect different roles in the study, but further details are not reported in the registry record. It is therefore appropriate to describe their adverse-event entries separately without interpreting the difference between them as a treatment effect.
How should a binary count be understood?
A binary participant outcome reduces the clinical event definition to whether a participant experienced at least one qualifying event. This approach is straightforward to communicate, but it does not show the total number of events when a participant can have more than one, nor does it show the mix of event types. For MACCE, the registry defines the qualifying events as myocardial infarction, stroke, or death. Component-specific results would be needed to understand the contribution of each event type; those results are not reported in the registry record.
General statistical interpretation also distinguishes a point estimate from its precision. A confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrow interval generally indicates greater precision than a wide interval, while an estimate alone does not show how much uncertainty remains. The registry record does not report a confidence interval for the primary endpoint, so its precision cannot be evaluated from this record.
Why do the analysis population and denominator matter?
An outcome count depends on who was included in the analysis. The primary endpoint description names roll-in, pivotal, and ITT populations, but the final wording describing ITT is truncated. The registry record does not report which of these populations formed the primary analysis or provide the primary endpoint count and denominator. Without that information, readers cannot determine precisely which participants the primary result would represent.
Missing outcome data can also affect interpretation. In general, if some participants lack outcome information, the analysis needs to describe how those participants were handled and whether assumptions were made about their outcomes. Different approaches can lead to different estimates. The registry record does not report the amount of missing primary outcome data or the method used to address it. No method should be inferred from the enrollment or group counts alone.
What can be said about the reported adverse-event counts?
The adverse-event information separates serious adverse events from other adverse events and presents participant counts at risk and affected in the roll-in and pivotal groups. These are descriptive safety data. They should be read with their group labels and denominators rather than treated as a comparison with an external control. The registry record does not provide event-level detail, attribution methods, or information about whether a participant could contribute to more than one event term.
The listed top serious adverse-event terms are accompanied by percentages, but the registry record does not state the denominator or calculation method for those percentages. In general, percentages are interpretable only when the population, counting rule, and denominator are clear. A participant-level percentage and an event-level percentage answer different questions, and the record does not resolve that distinction for the listed terms.
What do the planning calculations represent?
General sample-size calculations estimate how much information a future study might need under specified assumptions. They do not describe the number of participants actually observed with an outcome, and they are not observed power. The planning illustration associated with the posted results is based on an observed effect and assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers effects stated as fractions of the observed effect.
Those assumptions are not a report of the ARMOUR design: the registry records a single-group study and no randomized comparison. The planning illustration should therefore be understood as a hypothetical planning exercise rather than as the study's own sample-size justification. The sample-size justification is not reported in the registry record.
The registry lists one analysis, but does not describe the statistical methods used for it. The record does not state whether estimates were adjusted, what inferential procedures were used, or whether any interim analyses occurred. These details cannot be reconstructed from the outcome definitions or adverse-event counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary MACCE endpoint and secondary outcomes for device success, technical success, procedural success, restenosis at 30 days, target lesion revascularization at 30 days, and access site adverse events. The record lists seven outcome measures overall and one analysis. The statistical plan, including how outcomes were prioritized analytically or whether any adjustment for multiple testing was planned, is not reported in the registry record.
Multiplicity matters in general when several outcomes or several statistical tests are examined. With more opportunities to identify a statistically notable result, the interpretation of individual tests can change. Whether this issue applies to the reported analyses depends on the planned tests and their interpretation. The registry record does not provide enough information to determine the testing strategy, and it does not report primary endpoint test results.
The primary endpoint description refers to roll-in, pivotal, and ITT populations, but the ITT wording is incomplete. The population used for the primary analysis is not reported in the registry record. The record also does not report how missing endpoint observations were handled, whether participants were excluded from an analysis, or whether sensitivity analyses were conducted. These omissions limit assessment of which participants the analysis represents and how robust any estimate might be to incomplete outcome data.
The registry's single-group design and lack of a listed comparator are important when interpreting any endpoint findings. The posted adverse-event counts are descriptive and do not create a randomized contrast. The record does not report a detailed statistical analysis plan or interim-analysis procedures; neither should be inferred from the listed analysis count.
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 |
|---|---|---|---|
| MO.MA Roll-In Cases | 11 | 37 | 29.7% |
| MO.MA Pivotal Subjects | 37 | 225 | 16.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| MO.MA Roll-In Cases | 27 of 37 |
| MO.MA Pivotal Subjects | 132 of 225 |
Most frequent serious adverse event terms
| Event term | Organ system | MO.MA Roll-In Cases | MO.MA Pivotal Subjects |
|---|---|---|---|
| Hypotension | Vascular disorders | 7 of 37 | 6 of 225 |
| Anaemia | Blood and lymphatic system disorders | 0 of 0 | 4 of 225 |
| Bradycardia | Cardiac disorders | 1 of 37 | 2 of 225 |
| Renal failure | Renal and urinary disorders | 0 of 0 | 3 of 225 |
| Cerebrovascular accident | Nervous system disorders | 0 of 0 | 2 of 225 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 0 | 2 of 225 |
| Haemoglobin decreased | Investigations | 0 of 0 | 2 of 225 |
| Pneumonia | Infections and infestations | 0 of 0 | 2 of 225 |
| Syncope | Nervous system disorders | 0 of 0 | 2 of 225 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 1 of 37 | 1 of 225 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MO.MA Roll-In Cases | MO.MA Pivotal Subjects |
|---|---|---|---|
| Hypotension | Vascular disorders | 17 of 37 | 51 of 225 |
| Bradycardia | Cardiac disorders | 6 of 37 | 13 of 225 |
| Hypertension | Vascular disorders | 3 of 37 | 13 of 225 |
| Headache | Nervous system disorders | 2 of 37 | 8 of 225 |
| Anaemia | Blood and lymphatic system disorders | 0 of 0 | 9 of 225 |
| Sinus bradycardia | Cardiac disorders | 1 of 37 | 8 of 225 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 37 | 7 of 225 |
| Loss of consciousness | Nervous system disorders | 0 of 0 | 8 of 225 |
| Nausea | Gastrointestinal disorders | 1 of 37 | 7 of 225 |
| Vomiting | Gastrointestinal disorders | 0 of 0 | 8 of 225 |
Serious events with the highest arm-level rate: hypotension (18.9%), bradycardia (2.7%), chronic obstructive pulmonary disease (2.7%), confusional state (2.7%), convulsion (2.7%).
The registry record lists serious and other adverse-event counts separately for MO.MA Roll-In Cases and MO.MA Pivotal Subjects. For roll-in cases, 11 of 37 participants at risk are listed as affected by serious adverse events, and 27 of 37 by other adverse events. For pivotal subjects, the corresponding counts are 37 of 225 and 132 of 225. These entries describe participants affected, not a comparison with a control group.
The record also lists hypotension at 18.9% as a top serious adverse-event term, with bradycardia, chronic obstructive pulmonary disease, confusional state, convulsion, and diverticular perforation each at 2.7%. It does not report the denominator, calculation method, or whether participants could be represented under multiple terms. These percentages therefore need to be read as registry-listed values without inferring a specific event-counting rule.
Deaths are not reported in the registry record. The listed serious adverse-event counts should not be substituted for the primary MACCE result: the primary endpoint includes myocardial infarction, stroke, or death through 30 days, and its result is not reported in the registry record. The adverse-event entries also do not establish that an event was caused by the device, because attribution details are not reported.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study's stated purpose, single-group structure, intervention, and primary outcome definition. It also provides adverse-event counts for roll-in and pivotal groups. These elements describe what ARMOUR set out to evaluate and what safety information is recorded. They do not, on their own, answer how frequently the primary endpoint occurred, because the MACCE result is not reported in the registry record.
The record does not support a direct comparison of the Mo.Ma device with a different device, a different procedure, or no device. No comparator group is listed, and the study is recorded as single-group. Consequently, the adverse-event counts cannot be interpreted as evidence that the device caused or prevented an event relative to an alternative. The record also does not report a control-based estimate of relative or absolute effect.
The MACCE definition combines myocardial infarction, stroke, and death over a specified post-procedure period. A reported composite result would indicate the number of participants with at least one of those events, but would not by itself explain which component occurred. The registry record does not report that composite count or component-specific findings. It also does not report a confidence interval, so the precision of any primary estimate cannot be assessed.
The adverse-event figures are useful as descriptive entries within the registry, but their interpretation is limited by missing detail about event attribution, term-level denominators, and the relationship between the listed groups. The record does not report the primary analysis population in a complete form, missing-data handling, or detailed analysis methods. Those omissions prevent a full assessment of the statistical basis and scope of the results.
In general, study objectives and recorded outcomes should be distinguished from demonstrated findings. ARMOUR's stated objective was to evaluate safety and effectiveness, but the objective itself is not a result. The posted information allows readers to identify the intended question and some safety counts; it does not establish a comparative benefit or harm, or provide a complete estimate of the primary outcome.
13. Why This Trial Matters Statistically
This study is statistically notable as a registry-recorded, single-group evaluation of a device in a procedural setting. That structure shapes the questions the results can answer. A single-group design can describe outcomes among participants in the study, but it does not generate a randomized comparison against another strategy. Readers therefore need to distinguish descriptive event frequencies from comparative treatment effects.
The primary endpoint is a combined binary outcome spanning myocardial infarction, stroke, and death through 30 days after the procedure. Such an endpoint can provide a concise summary of whether participants experienced any event in a defined set. At the same time, a composite can conceal differences among its components. Component-specific results and an uncertainty measure would help readers understand the event pattern and precision, but they are not reported in the registry record.
The adverse-event entries also illustrate why denominators and analysis populations matter. The record provides affected counts and at-risk counts for roll-in and pivotal groups, while the primary endpoint population description is incomplete. These details are not interchangeable: safety counts do not fill the gap in the primary endpoint result, and group labels do not make a controlled comparison.
The accompanying sample-size planning illustration is another useful statistical distinction. It uses a two-arm, equal-allocation framework, a two-sided significance level of 0.05, and a normal approximation, while ARMOUR is recorded as a single-group study. The illustration is not the trial's own design or sample-size justification, and a planning calculation is not observed power. The actual sample-size justification is not reported in the registry record.
Overall, the record shows why design, endpoint definition, analysis population, and reporting completeness all matter. Without the primary outcome result and its precision, the central clinical outcome cannot be statistically characterized from the posted record.
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 primary endpoint result is not reported in the registry record. The record therefore does not supply the MACCE participant count, denominator for that result, or a measure of precision. Component-specific results for myocardial infarction, stroke, and death are also not reported in the registry record.
The study is recorded as single-group, with allocation listed as NA and no separate comparator. This limits interpretation to description of outcomes in the study groups; it does not support a randomized estimate of the device's effect relative to another strategy. The roll-in and pivotal groups should not be treated as like-for-like control arms. Details needed to understand the distinction between those groups are not reported in the registry record.
The endpoint population description includes roll-in, pivotal, and ITT wording, but the ITT text is incomplete. The population used for the primary analysis is not reported in the registry record. Nor are missing outcome data, the method for handling missingness, exclusions, or sensitivity analyses reported.
The registry record does not report a detailed statistical analysis plan, adjustment methods, inferential tests, or interim-analysis procedures. It also does not provide the denominator or calculation method for the percentages attached to the top serious adverse-event terms. Deaths and event attribution are not reported in the registry record. These gaps limit assessment of the primary endpoint, the precision of estimates, and the interpretation of adverse-event terms.
Finally, the sample-size planning illustration uses assumptions for two arms and equal allocation, whereas the registry records a single-group study. It should not be taken as the study's design rationale. The sample-size justification is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Proximal Protection With The Mo.Ma Device During Carotid Stenting — NCT00744523.
- Registry record last updated 2016-02-26; status last verified 2016-01.
- Results first posted 2010-05-05.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
ARMOUR (NCT00744523) is recorded as a completed, single-group study of the Mo.Ma cerebral protection device during carotid stenting. The registry lists 262 participants, a study start of 2007-09, and primary completion in 2009-03. Its stated objective was to evaluate the safety and effectiveness of the device among patients at high surgical risk for carotid endarterectomy who undergo carotid artery stenting.
The primary endpoint counts participants with one or more myocardial infarctions, strokes, or deaths through 30 days after the procedure. The primary endpoint result is not reported in the registry record. The adverse-event record lists serious and other adverse-event counts for roll-in and pivotal groups, but these are not a controlled treatment comparison. The record does not report the primary analysis population in complete form, the handling of missing data, or a detailed statistical analysis plan.