Trial Outcomes & Findings for GORE Embolic Protection With Reverse Flow (NCT NCT00594100)
NCT ID: NCT00594100
Last Updated: 2013-12-27
Results Overview
Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
Treatment through 30-day visit window
Results posted on
2013-12-27
Participant Flow
The study was approved to enroll subjects from a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices).
Participant milestones
| Measure |
GFRS Pivotal Subjects
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Procedure
STARTED
|
245
|
|
Procedure
COMPLETED
|
236
|
|
Procedure
NOT COMPLETED
|
9
|
|
Follow-up Through 30 Days Post Procedure
STARTED
|
236
|
|
Follow-up Through 30 Days Post Procedure
COMPLETED
|
224
|
|
Follow-up Through 30 Days Post Procedure
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
GFRS Pivotal Subjects
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Procedure
Technical Failure
|
9
|
|
Follow-up Through 30 Days Post Procedure
Death / Reintervention / Medical Reasons
|
2
|
|
Follow-up Through 30 Days Post Procedure
Discontinued Prior to Visit
|
6
|
|
Follow-up Through 30 Days Post Procedure
Missed Visit - Phone Contact Follow-up
|
4
|
Baseline Characteristics
GORE Embolic Protection With Reverse Flow
Baseline characteristics by cohort
| Measure |
GFRS Pivotal Subjects
n=245 Participants
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Age, Continuous
|
71.0 years
n=5 Participants
|
|
Age, Customized
< 80 years
|
207 participants
n=5 Participants
|
|
Age, Customized
>= 80 years
|
38 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=5 Participants
|
|
History of Diabetes
Yes
|
86 participants
n=5 Participants
|
|
History of Diabetes
No
|
159 participants
n=5 Participants
|
|
History of Hypertension
Yes
|
212 participants
n=5 Participants
|
|
History of Hypertension
No
|
33 participants
n=5 Participants
|
|
History of Ischemic Stroke
None
|
192 participants
n=5 Participants
|
|
History of Ischemic Stroke
One
|
42 participants
n=5 Participants
|
|
History of Ischemic Stroke
Two or More
|
11 participants
n=5 Participants
|
|
Previous Endarterectomy
None
|
143 participants
n=5 Participants
|
|
Previous Endarterectomy
Less than 1 Year
|
23 participants
n=5 Participants
|
|
Previous Endarterectomy
Greater than 1 Year
|
79 participants
n=5 Participants
|
|
Symptomatic
Symptomatic
|
78 participants
n=5 Participants
|
|
Symptomatic
Asymptomatic
|
167 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment through 30-day visit windowPopulation: All primary endpoint evaluable subjects
Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)
Outcome measures
| Measure |
GFRS Pivotal Subjects
n=202 Participants
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Composite Major Adverse Event (MAE) Rate
Major Ischemic Stroke
|
0 participants
|
|
Composite Major Adverse Event (MAE) Rate
Minor Ischemic Stroke
|
5 participants
|
|
Composite Major Adverse Event (MAE) Rate
Hemorrhagic Stroke
|
2 participants
|
|
Composite Major Adverse Event (MAE) Rate
Death
|
2 participants
|
|
Composite Major Adverse Event (MAE) Rate
Death / Any Stroke
|
7 participants
|
|
Composite Major Adverse Event (MAE) Rate
Myocardial Infarction (MI)
|
2 participants
|
|
Composite Major Adverse Event (MAE) Rate
Death / Stroke / MI
|
9 participants
|
|
Composite Major Adverse Event (MAE) Rate
Transient Ischemic Attack (TIA)
|
2 participants
|
|
Composite Major Adverse Event (MAE) Rate
Overall MAE
|
11 participants
|
SECONDARY outcome
Timeframe: ProcedurePopulation: All enrolled subjects
Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)
Outcome measures
| Measure |
GFRS Pivotal Subjects
n=245 Participants
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Flow Reversal System Technical Success
|
236 participants
|
SECONDARY outcome
Timeframe: ProcedureNumber of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.
Outcome measures
| Measure |
GFRS Pivotal Subjects
n=245 Participants
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Flow Reversal System Success
|
233 participants
|
SECONDARY outcome
Timeframe: ProcedurePopulation: All enrolled subjects with post procedure angiographic assessment of lesion stenosis
Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of \< 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.
Outcome measures
| Measure |
GFRS Pivotal Subjects
n=230 Participants
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Stent Success
|
228 participants
|
SECONDARY outcome
Timeframe: 24-48 Hours Post-ProcedurePopulation: All enrolled subjects with post procedure angiographic assessment of lesion stenosis
Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).
Outcome measures
| Measure |
GFRS Pivotal Subjects
n=230 Participants
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Clinical Success
|
211 participants
|
SECONDARY outcome
Timeframe: Treatment through 30-day visit windowPopulation: Subjects with successful stent placement and ultrasound evaluation at 30-day follow-up evaluation.
Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.
Outcome measures
| Measure |
GFRS Pivotal Subjects
n=186 Participants
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Patency at 30 Days
|
182 participants
|
Adverse Events
GFRS Pivotal Subjects
Serious events: 40 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GFRS Pivotal Subjects
n=245 participants at risk
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Cardiac disorders
Hypotension
|
5.7%
14/245 • Number of events 14 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Blood and lymphatic system disorders
Groin Hematoma (w/wo Surgical Repair)
|
0.82%
2/245 • Number of events 2 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Blood and lymphatic system disorders
Other (Bleeding)
|
1.2%
3/245 • Number of events 3 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
4/245 • Number of events 4 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Cardiac disorders
Angina/Coronary Ischemia
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Cardiac disorders
Arrhythmia
|
1.6%
4/245 • Number of events 4 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Cardiac disorders
Congestive Heart Failure (CHF)
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Cardiac disorders
Myocardial Infarction (MI)
|
1.2%
3/245 • Number of events 3 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Stroke/Cerebrovascular accident (CVA)
|
2.0%
5/245 • Number of events 5 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Cerebral ischemia/Transient ischemic attack (TIA)
|
0.41%
1/245 • Number of events 3 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Cardiac disorders
Other (Cardiac)
|
1.6%
4/245 • Number of events 4 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Renal and urinary disorders
Renal Failure/Insufficiency
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Infections and infestations
Other (Infectious/Inflammatory)
|
1.2%
3/245 • Number of events 3 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Other (Neurologic)
|
0.82%
2/245 • Number of events 3 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Hyperperfusion Syndrome
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Pain (Head, Neck)
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Surgical and medical procedures
Other (Surgical Procedure)
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Vascular disorders
Pseudoaneurysm (Femoral)
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Injury, poisoning and procedural complications
Other (Wound)
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
General disorders
Other (Other)
|
2.0%
5/245 • Number of events 6 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Cerebral Hemorrhage
|
0.41%
1/245 • Number of events 1 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
Other adverse events
| Measure |
GFRS Pivotal Subjects
n=245 participants at risk
All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
3.3%
8/245 • Number of events 8 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Cardiac disorders
Hypotension
|
11.4%
28/245 • Number of events 28 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Cardiac disorders
Hypertension
|
4.9%
12/245 • Number of events 13 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Other (Neurologic)
|
3.7%
9/245 • Number of events 11 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Nervous system disorders
Pain (Head, Neck)
|
4.5%
11/245 • Number of events 11 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
|
Surgical and medical procedures
Other (Other)
|
7.3%
18/245 • Number of events 19 • 30 days postprocedure (0-40 days given 10-day late follow-up window)
AEs reported by investigative sites via Adverse Event Case Report Form (CRF), using study-specific coding. Site-reported adverse events that were potential Major Adverse Events (stroke or TIA) were adjudicated by the independent Clinical Events Committee.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER