Comparison · NCT00816166-sae
Stent Group vs Medical Therapy Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Stent Group vs Medical Therapy Group: serious adverse events. Trial comparisons, record NCT00816166-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00816166-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.517 | 0.392 | 0.641 | wilson | |
| Risk in group 2 | 0.377 | 0.259 | 0.512 | wilson | |
| Risk difference, group 1 minus group 2 | 0.14 | -0.0442 | 0.311 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.37 | 0.895 | 2.1 | log | |
| Odds ratio, group 1 over group 2 | 1.77 | 0.829 | 3.77 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Stent Group than on Medical Therapy Group | 7.15 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Stent Group | Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions. | 30 | 58 | EG000 |
| Group 2 | Medical Therapy Group | Medical therapy alone (Medical Therapy Group)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months) | 20 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Source ClinicalTrials.gov
Trial
- Title
- VISSIT Intracranial Stent Study for Ischemic Therapy
- NCT number
- NCT00816166
- Phases
- PHASE2, PHASE3
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Interventions
- Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel), Aspirin and Clopidogrel (Medical therapy)
- Lead sponsor
- Codman & Shurtleff
- Results first posted
- 2014-06-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00816166?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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