ABSORB III Randomized Controlled Trial (RCT)
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
In brief
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS). The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and 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.
Key facts
- Study ID
- NCT01751906
- Run by
- Abbott Medical Devices
- People needed
- 2008
- Starts
- 2012-12-01
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2023-10-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama Hospital — Birmingham, Alabama, United States
- Thomas Hospital — Fairhope, Alabama, United States
- Baptist Medical Center South — Montgomery, Alabama, United States
- Chandler Regional Medical Center — Gilbert, Arizona, United States
- Banner Heart Hospital — Mesa, Arizona, United States
- Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
- Scottsdale Healthcare — Scottsdale, Arizona, United States
- Arkansas Heart Hospital — Little Rock, Arkansas, United States
- John Muir Medical Center - Concord Campus — Concord, California, United States
- Washington Hospital — Fremont, California, United States
- Scripps Green Hospital — La Jolla, California, United States
- Scripps Memorial Hospital — La Jolla, California, United States
- Good Samaritan Hospital — Los Angeles, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Sutter Central Valley Hospitals dba Memorial Medical Center — Modesto, California, United States
- Mercy General Hospital — Sacramento, California, United States
- UC Davis Medical Center — Sacramento, California, United States
- Sutter Medical Center — Sacramento, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
- Santa Barbara Cottage Hospital — Santa Barbara, California, United States
- Stanford Hospital and Clinics — Stanford, California, United States
- Little Company Of Mary Hospital — Torrance, California, United States
- Torrance Memorial Medical Center — Torrance, California, United States
- UCH-Memorial Health Systems — Colorado Springs, Colorado, United States
- Baptist Medical Center Princeton — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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