The PREVAIL Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2019-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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In-stent Restenosis Ischemic Heart Disease Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm (Mdt Drug-Coated Balloon)

Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion.

Group Type EXPERIMENTAL

Medtronic Coronary Drug-Coated Balloon Catheter

Intervention Type DEVICE

Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty

Interventions

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Medtronic Coronary Drug-Coated Balloon Catheter

Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty

Intervention Type DEVICE

Eligibility Criteria

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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.