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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060033 / PAS002 |
| Date Original Protocol Accepted |
02/01/2008
|
| Date Current Protocol Accepted |
09/16/2008
|
| Study Name |
Registry PROTECT CA
|
| Device Name |
ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
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| 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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| Detailed Study Protocol Parameters |
| Study Objectives |
This post-approval study (PAS) uses the pooled data from the PROTECT and PROTECT Continued Access (CA) studies in on-label patients to evaluate the annual rates of stent thrombosis (ST) and cardiac death (CD) plus myocardial infarction (MI) for all Endeavor on-label patients.
The PROTECT study is a prospective, multi-center, randomized, two-arm, open-label study. The primary objective is to compare the overall stent thrombosis rate of the Endeavor Zotarolimus-Eluting Coronary Stent System versus the Cypher Sirolimus-Eluting Coronary Stent System in a patient population requiring stent implantation.
The PROTECT CA study is a prospective, multi-center, non-randomized, single-arm, open label study. The primary objective is to evaluate the overall stent thrombosis rate of the Endeavor Zotarolimus-Eluting Coronary Stent System in a patient population requiring stent implantation.
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| Study Population |
The PROTECT and PROTECT CA patient populations include consecutive patients eligible for drug-eluting stent implantation in one or more target lesions. Patients with lesions in native coronary arteries who met all eligibility criteria were enrolled.
|
| Sample Size |
A minimum of 1,000 Endeavor patients will be enrolled in the US, including:
a. US patients enrolled in the PROTECT study and randomized to ¿Endeavor¿; and
b. US patients enrolled in a single arm fashion in PROTECT CA.
Sites: 60 to 100 US sites
|
| Key Study Endpoints |
Primary Endpoint
ST rate defined as definite and probable stent thrombosis, according to the ARC definition.
Secondary Endpoint
CD/MI composite endpoint. CD defined as any death due to immediate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia). MI per Medtronic historical definition (Q wave or non-Q wave MI).
|
| Follow-up Visits and Length of Follow-up |
Length of follow-up: 5 years
Follow up at: 1, 6 , 12, 18, 24, 30, 36, 48, and 60 months
|
| Interim or Final Data Summary |
| Interim Results |
None reported for this portion of study.
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| Actual Number of Patients Enrolled |
The PAS analyses included 1,769 on-label patients.
|
| Actual Number of Sites Enrolled |
64 sites
|
| Patient Follow-up Rate |
At five years the follow-up rate was 94.6% (1673/1769).
|
| Final Safety Findings |
The annual rate of ARC-defined definite and probable stent thrombosis at 5 years for on-label patients in
PROTECT and PROTECT CA studies was 0.06% (1/1673, upper 95% CI: 0.28%, p<0.001).
|
| Final Effect Findings |
The 5-year cumulative rate of cardiac death or myocardial infarction for on-label patients in PROTECT and PROTECT CA studies was 6.40% (107/1673). This rate is below the performance goal of 8.4% (p<0.001)
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| Study Strengths & Weaknesses |
The study had a low rate of attrition, thus minimizing selection bias. The study met its performance goals and had a large sample size showing a long-term outcome of the stent
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| Recommendations for Labeling Changes |
A labeling change is not needed because Medtronic Vascular has ceased manufacturing and distribution of the Endeavor Spring OTW and RX devices.
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