Trial Outcomes & Findings for GORE Flow Reversal System and GORE Embolic Filter Extension Study (NCT NCT01343667)
NCT ID: NCT01343667
Last Updated: 2016-02-19
Results Overview
Major Adverse Events include death, stroke and myocardial infarction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1397 participants
Primary outcome timeframe
Onset from start of index procedure to 30-day follow-up assessment
Results posted on
2016-02-19
Participant Flow
Participant milestones
| Measure |
GFRS EPD
Carotid artery stenting with Gore Flow Reversal System
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
|
GEF EPD
Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
|
|---|---|---|
|
Overall Study
STARTED
|
425
|
972
|
|
Overall Study
COMPLETED
|
413
|
916
|
|
Overall Study
NOT COMPLETED
|
12
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GORE Flow Reversal System and GORE Embolic Filter Extension Study
Baseline characteristics by cohort
| Measure |
GFRS EPD
n=425 Participants
Carotid artery stenting with Gore Flow Reversal System
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
|
GEF EPD
n=972 Participants
Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
|
Total
n=1397 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
73.0 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
72.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
587 Participants
n=7 Participants
|
726 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
286 Participants
n=5 Participants
|
385 Participants
n=7 Participants
|
671 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
414 Participants
n=5 Participants
|
955 Participants
n=7 Participants
|
1369 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
26 participants
n=5 Participants
|
56 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
381 participants
n=5 Participants
|
901 participants
n=7 Participants
|
1282 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Onset from start of index procedure to 30-day follow-up assessmentPopulation: Enrolled subjects with successful procedure and sufficient follow-up
Major Adverse Events include death, stroke and myocardial infarction
Outcome measures
| Measure |
GFRS EPD
n=386 Participants
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
|
GEF EPD
n=864 Participants
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
|
|---|---|---|
|
Major Adverse Events (MAE)
|
18 participants
|
36 participants
|
Adverse Events
GFRS EPD
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
GEF EPD
Serious events: 36 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GFRS EPD
n=425 participants at risk
Carotid artery stenting with Gore Flow Reversal System
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
|
GEF EPD
n=972 participants at risk
Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
|
|---|---|---|
|
Cardiac disorders
All Cause Death
|
0.47%
2/425 • Number of events 2 • 30-day visit window
The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
|
1.0%
10/972 • Number of events 10 • 30-day visit window
The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
6/425 • Number of events 6 • 30-day visit window
The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
|
0.31%
3/972 • Number of events 3 • 30-day visit window
The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
|
|
Nervous system disorders
Stroke
|
3.3%
14/425 • Number of events 14 • 30-day visit window
The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
|
3.2%
31/972 • Number of events 31 • 30-day visit window
The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
|
Other adverse events
Adverse event data not reported
Additional Information
Bryan Randall, Clinical Biostatistician
W. L. Gore & Associates
Phone: 928-864-4832
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place