ABSORB III Clinical Trial
A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions
Absorb III is a prospective, randomized, single-blind, multi-center trial. The study is the pivotal trial to support US pre-market approval of Absorb BVS. Absorb III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo coronary artery lesions in separate epicardial vessels. Subjects will be followed at 30 days, 6 months, and once a year for five years.
Sponsor: Abbott Vascular, Inc.
Principal investigator: Ethan Korngold, M.D.
Contact: Trent Foxley, CRC, clinical research coordinator, 503-216-7195
The ABSOLUTE PRO® MOMENTUM™ Trial
A prospective, multicenter, nonrandomized, single-arm clinical trial to evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® Ll Peripheral Self-Expanding Stent System in the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery and/or native proximal popliteal artery
Sponsor: Abbott Vascular Inc.
Principal investigator: Ethan Korngold, M.D.
Contact: Ellen Muir, CCRC, clinical research coordinator, 503-216-2110
MOBILITY Trial (in follow-up)
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System (Absolute Pro stent) and the Omnilink Elite™ Peripheral Balloon-Expandable Stent System (Omnilink Elite stent) in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Inclusion criteria
- Subjects for treatment must have patent superficial femoral and popliteal arteries on the treatment side(s) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot as confirmed by arteriography. Patent is defined as <50% stenosis.
- This trial allows the treatment of a maximum of two bilateral de novo or restenotic (prior PTA) atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side). If a target lesion is within an iliac artery that has been previously stented, that subject may not be enrolled in the clinical trial.
- History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
Exclusion criteria
- Subject is unable to walk
- Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5 or 6
- Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s)
- Subject has uncontrolled diabetes mellitus (DM) (serum glucose >400 mg/dl)
Principal investigator: Ethan Korngold, M.D.
Sponsor: Abbott Vascular
Contact: Ellen Muir, CCRC, clinical research coordinator, 503-216-2110
GORE® TIGRIS® Vascular Stent Clinical Study
Evaluation of the GORE® TIGRIS® vascular stent in the treatment of atherosclerotic lesions of the superficial femoral and proximal popliteal arteries.
Principal investigator: Ethan Korngold, M.D.
Sponsor: W.L. Gore and Associates, Inc.
Contact: Ellen Muir, CCRC, clinical research coordinator, 503-216-2110, or Carmen Dahlberg, CRC, clinical research coordinator, 503-216-7370