The PREVAIL Study
NCT03260517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-09-30
Summary
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.
Conditions
- In-stent Restenosis
- Ischemic Heart Disease
- Coronary Artery Disease
Interventions
- DEVICE
-
Medtronic Coronary Drug-Coated Balloon Catheter
Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty
Sponsors & Collaborators
-
Medtronic Vascular
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-02
- Primary Completion
- 2019-01-29
- Completion
- 2019-08-01
Countries
- Belgium
- Italy
- Netherlands
Study Locations
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