The PREVAIL Study

Medtronic Vascular50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

In-stent Restenosis Ischemic Heart Disease Coronary Artery Disease

Interventions

Medtronic Coronary Drug-Coated Balloon CatheterDEVICE

Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (10)

ZNA Middelheim

Antwerp, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

CHU Liege

Liège, Belgium

IRCCS Policlinico San Donato

Milan, Italy

Outcomes

Primary Outcomes

In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months

The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint.

Time frame: At 6 months follow up

Secondary Outcomes

All deaths including cardiac death.procedure

Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure

Time frame: 30 days, 6 months and 1 year after procedure

Target Vessel Myocardial Infarction (TVMI)

Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure

Time frame: 30 days, 6 months and 1 year after procedure

Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods

Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures

Time frame: 30 days, 6 months and 1 year after procedure

Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.

Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures

Time frame: 30 days, 6 months and 1 year after procedure

5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.

Data from ClinicalTrials.gov

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