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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030025 / PAS001 |
| Date Original Protocol Accepted |
03/04/2004
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| Date Current Protocol Accepted |
03/04/2004
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| Study Name |
ARRIVE I
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| Device Name |
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The ARRIVE Program consists of 2 safety surveillance registries which enrolled 7,601 patients at 103 United States (US) based sites. ARRIVE 1 is a peri-approval registry established to satisfy the Agency's conditions of approval and ARRIVE 2 is a sponsor-initiated postmarket registry. ARRIVE 1 and ARRIVE 2 were designed to study common physician usage patterns and safety outcomes with the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (hereafter referred to as the TAXUS stent).
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| Study Population |
This device is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2. 25 to <4. 0mm in diameter in lesions < 28mm in length. In there overall conclusions the sponsor states that through consecutive enrollment the ARRIVE 1 registry captured a full spectrum of patients and treatments, which were generally more complex than that seen in the controlled TAXUS stent clinical trials. In contrast to the TAXUS IV trial, for example, where the majority of patients received a single stent for a single lesion, approximately 65% of ARRIVE 1 patients were considered higher risk and underwent more complex procedures. These included patients with AMI and treatments for ISR, grafts, chronic total occlusions, bifurcation lesions, and LM disease. The demographic characteristics of the ARRIVE population are typical of most registries.
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| Sample Size |
7,601 patients, 103 sites
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| Key Study Endpoints |
The primary endpoint was the rate of protocol-defined TAXUS stent-related cardiac events at 1 year after the implant procedure as adjudicated by the Clinical Events Committee with 100% of cardiac adverse event data verified against source documents. Despite inclusion of high risk patients and lesions outside the approved indications, the sponsor believes that the observed outcomes from ARRIVE indicate a safety profile consistent with data from randomized controlled trials with the TAXUS stent.
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| Follow-up Visits and Length of Follow-up |
The sponsor compares the patient populations as well as rates of cardiac events for ARRIVE 1 and ARRIVE 2 at 1 and 2 year intervals.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
7601 patients
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| Actual Number of Sites Enrolled |
103 sites
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| Patient Follow-up Rate |
93%
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| Final Safety Findings |
The sponsor provides the final report for the ARRIVE 1 registry. The ARRIVE 1 TAXUS stent-related major cardiac event rate of 9.9% for the 2-year follow-up period is consistent with previous TAXUS programs. The 2-year follow-up of 93% was very good. The sponsor did note higher outcome rates in the target vessel revascularization patients, driven mainly by subsequent arget vessel revascularization , and this may reflect the higher-risk nature of this patient group.
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| Study Strengths & Weaknesses |
Strengths: ARRIVE 1 was designed to minimize selection bias by requesting that each participating physician enroll patients in a consecutive manner. Weaknesses: There was no concurrently enrolled control in this study.
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| Recommendations for Labeling Changes |
The label was updated to reflect ARRIVE 1 results.
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