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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040038 / PAS001 |
| Date Original Protocol Accepted |
02/05/2007
|
| Date Current Protocol Accepted |
02/05/2007
|
| Study Name |
PROTECT Study
|
| Device Name |
XACT CAROTID STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Interim or Final Data Summary |
| Interim Results |
There have been no unanticipated adverse device effects or rare events thus far in the trial. The sponsor demonstrates high procedural success rates with very low stroke number and no unanticipated adverse events. (Note: 6.89 % of the pre-market cohort experienced a stroke at 30 days. The data here show no concern about the safety and effectiveness of carotid artery stenting using the Xact stent at 2-years.
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| Actual Number of Patients Enrolled |
A total of 322 patients have been enrolled into the study.
|
| Actual Number of Sites Enrolled |
There are a total of 38 study sites that enrolled patients.
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| Patient Follow-up Rate |
Follow-up rate is 75.2% (242/322).
|
| Final Safety Findings |
1) A total of six clinically driven target revascularization (TLR) events were reported in five patients. The event free rate is 99.3% at one year, 98.2% at two years, and 98.2% at three years showing a higher (1.0~1.2%) event free percentage compared to the historical control group in the ARCHeR long term follow-up (LTFU) study.
2) Two point five percent (2.5%, 8/322) of patients experienced stoke and zero point nine percent (0.9%, 3/322) of patients experienced MI within 30 days post index procedure. Three point seven percent (3.7%, 12/322) of patients experienced stroke and four point seven percent of patients (4.7%, 15/322) experienced MI between 31 days and 3 years.
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| Final Effect Findings |
The primary endpoint was a composite of DSMI at 30 days, plus ipsilateral stroke between days 31 and 365 and annually thereafter for 3 years. A total of 14 events were reported of which 11 events occurred within 30 days of procedure and 3 events occurred after 30 days during long-term follow-up. The overall composite event free rate is 96.6% at one year, 95.9% at two years, and 95.5% at three years showing a higher event free percentage at one-, two-, and three-year compared to the historical control group in the ARCHeR long term follow-up (LTFU) study.
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| Study Strengths & Weaknesses |
Strength:
The study provides long term follow-up of patients at high risk for adverse events from carotid endarterectomy implanted with the Xact stent in the treatment of atherosclerotic carotid artery disease.
Weakness:
1) Low percentage of minority group participants restricts the generalization of the results.
2) Only descriptive analysis is available for this study. No statistical tests are being made for the comparison of event free rate between the study cohort and the historical control group in the ARCHeR long term follow-up (LTFU) study.
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| Recommendations for Labeling Changes |
Yes, labeling will be updated with the 3-year data.
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