The PREVAIL Study
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria
- Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
- Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki.
Key Exclusion Criteria
- Acute Myocardial Infarction within the previous 72 hours
- Planned treatment involves a bifurcation
- Three vessel disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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