Last updated on September 2018

Absorb IV Randomized Controlled Trial


Brief description of study

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 3000 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS. The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.

Detailed Study Description

ABSORB IV: A. Primary Objective: - 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 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 the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE. The enrollment of the 3000 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, potentially at 6 and/or 7 years if it is necessary as determined by the Sponsor. In addition, all 3000 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, and annually throughout the remaining duration of the trial. The ABSORB IV trial will also include an imaging ischemia sub-study which will provide the physiological and mechanistic evaluation of whether percutaneous coronary intervention (PCI) treatment with Absorb compared to XIENCE results in differences in myocardial ischemia in the early post-procedural period, and at 14 months and 62 months.

Clinical Study Identifier: NCT02173379

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Antonis Pratsos

Bryn Mawr
Bryn Mawr, PA United States

Gene Chang

Penn Presbyterian Medical Center
Philadelphia, PA United States
8.05miles