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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Completed
Application Number P030025 / PAS001
Date Current Protocol Accepted 03/04/2004
Study Name ARRIVE I
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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).
Study Population Description 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.
Sample Size 7,601 patients, 103 sites
Data Collection 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.
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.
Interim or Final Data Summary
Actual Number of Patients Enrolled 7601 patients
Actual Number of Sites Enrolled 103 sites
Patient Follow-up Rate 93%
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.
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.
Recommendations for Labeling Changes The label was updated to reflect ARRIVE 1 results.

ARRIVE I Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final ARRIVE I Registry Report 11/24/2007 11/23/2007 On Time
Final ARRIVE I Report 03/05/2008 03/05/2008 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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