Absorb IV Randomized Controlled Trial
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
In brief
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 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.
Key facts
- Study ID
- NCT02173379
- Run by
- Abbott Medical Devices
- People needed
- 2604
- Starts
- 2014-07-01
- Expected to finish
- 2022-04-06
- Last updated by the study team
- 2023-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Chandler Regional Medical Center — Chandler, Arizona, United States
- Mercy Gilbert Medical Center — Gilbert, Arizona, United States
- Scottsdale Healthcare — Scottsdale, Arizona, United States
- Arkansas Heart Hospital — Little Rock, Arkansas, United States
- John Muir Health Concord — Concord, California, United States
- Washington Hospital — Fremont, California, United States
- Scripps Memorial Hospital La Jolla — La Jolla, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Univ Of California Davis Med Ctr — Sacramento, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
- Stanford Hospital and Clinics — Stanford, California, United States
- Little Company Of Mary Hospital — Torrance, California, United States
- Medical Center of the Rockies — Loveland, Colorado, United States
- Yale-New Haven Hospital — New Haven, Connecticut, United States
- Morton Plant Hospital — Clearwater, Florida, United States
- Holy Cross Hospital — Fort Lauderdale, Florida, United States
- Baptist Medical Center Jacksonville — Jacksonville, Florida, United States
- UF Health Jacksonville — Jacksonville, Florida, United States
- Tallahassee Memorial Hospital — Tallahassee, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Advocate Christ Medical Center — Oak Lawn, Illinois, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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