Comparison · NCT01343667-7597cdf5
GFRS EPD vs GEF EPD: Major Adverse Events (MAE)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. GFRS EPD vs GEF EPD: Major Adverse Events (MAE). Trial comparisons, record NCT01343667-7597cdf5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01343667-7597cdf5
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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 | 0.0466 | 0.0297 | 0.0725 | wilson | |
| Risk in group 2 | 0.0417 | 0.0302 | 0.0571 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00497 | -0.018 | 0.0332 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.644 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.631 | 2.01 | log | |
| Number needed to treat, for one more participant with the outcome on GFRS EPD than on GEF EPD | 201 | 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 | GFRS EPD | Carotid artery stenting with Gore Flow Reversal System embolic protection device~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting | 18 | 386 | OG000 |
| Group 2 | GEF EPD | Carotid artery stenting with Gore Embolic Filter embolic protection device~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting | 36 | 864 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Major Adverse Events (MAE)
- Description
- Major Adverse Events include death, stroke and myocardial infarction
- Time frame
- Onset from start of index procedure to 30-day follow-up assessment
- Population
- Enrolled subjects with successful procedure and sufficient follow-up
Source ClinicalTrials.gov
Trial
- Title
- GORE Flow Reversal System and GORE Embolic Filter Extension Study
- NCT number
- NCT01343667
- Phases
- NA
- Conditions
Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical
- Interventions
- Gore Flow Reversal System, Gore Embolic Filter
- Lead sponsor
- W.L.Gore & Associates
- Results first posted
- 2016-02-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01343667?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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