Absorb IV Randomized Controlled Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 3000
Summary
- Conditions
- Coronary (Artery) Disease
- Coronary Artery Stenosis
- Coronary Disease
- Coronary Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
ABSORB IV: A. Primary Objective: To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per e...
ABSORB IV: A. Primary Objective: To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. B. Secondary Objectives: To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE. The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years. Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor. In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.
Tracking Information
- NCT #
- NCT02173379
- Collaborators
- Not Provided
- Investigators
- Study Chair: Gregg W Stone, MD Columbia University Medical Center, New York, NY Principal Investigator: Gregg W Stone, MD Columbia University Medical Center, New York, NY Principal Investigator: Stephen G Ellis, MD Cleveland Clinic, Cleveland OH Principal Investigator: Dean J Kereiakes, MD The Christ Hospital, Cincinnati, OH
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