Phase 3
Completed N=245
GORE Embolic Protection With Reverse Flow
Source: ClinicalTrials.gov NCT00594100 ↗Enrolled (actual)
245
Serious AEs
16.3%
Results posted
May 2009
Primary outcomePrimary: Composite Major Adverse Event (MAE) Rate — 0; 5; 2; 2 participants — p=0.002
Summary
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Major Adverse Event (MAE) Rate |
0; 5; 2; 2; 7; 2 | 0.002 sig |
| SECONDARY Flow Reversal System Technical Success |
236 | — |
| SECONDARY Flow Reversal System Success |
233 | — |
| SECONDARY Stent Success |
228 | — |
| SECONDARY Clinical Success |
211 | — |
| SECONDARY Patency at 30 Days |
182 | — |
Eligibility Criteria
Inclusion Criteria
- Carotid stenosis requiring revascularization and indicating either symptomatic status, with carotid stenosis ≥ 50% OR asymptomatic status with carotid stenosis ≥ 80%
- Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b) bifurcation (c) common carotid artery (CCA) proximal to the bifurcation
- At Anatomic risk for adverse events from CEA (e.g. restenosis after a prior CEA) OR at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)
Exclusion Criteria
- Recent surgical procedure within 30 days before or after the stent procedure
- Uncontrolled sensitivity to contrast media
- Renal Insufficiency
- Recent evolving, acute stroke within 21 days of study evaluation
- Myocardial infarction within 72 hours prior to stent procedure
- History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)
- Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)
Angiographic Exclusion Criteria:
- Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow
- Total occlusion of the ipsilateral carotid artery
- Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch
- Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel
- Severe lesion calcification restricting stent deployment
- Carotid stenosis located distal to target stenosis that is more severe than target stenosis
- > 50% stenosis of the CCA proximal to target vessel
- Known mobile plaque in the aortic arch
Data sourced from ClinicalTrials.gov (NCT00594100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.