Coronary Artery Disease Clinical Trial
Official title:
A Clinical PeRformance EVAluatIon of a New Medtronic Coronary Drug-Coated BaLloon Catheter for the Treatment of De Novo Lesions, In-Stent Restenosis and Small Vessel Disease in Coronary Arteries: The PREVAIL Study
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50
subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the
coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated
Balloon Catheter.
Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for
percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm
to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.
Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes
and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.
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