The PREVAIL Study

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 29, 2019

Detailed 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.

Interventions

  • Device: Medtronic Coronary Drug-Coated Balloon Catheter
    • Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty

Arms, Groups and Cohorts

  • Experimental: Treatment arm (Mdt Drug-Coated Balloon)
    • Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion.

Clinical Trial Outcome Measures

Primary Measures

  • In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months
    • Time Frame: At 6 months follow up
    • 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.

Secondary Measures

  • All deaths including cardiac death.procedure
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
  • Target Vessel Myocardial Infarction (TVMI)
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 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
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
  • Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
  • 5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
  • All revascularizations (TLR, TVR and non-TVR).
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
  • Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition).
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
  • Acute success (device, lesion and procedure success).
    • Time Frame: 30 days, 6 months and 1 year after procedure
    • Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Vascular
  • Provider of Information About this Clinical Study
    • Sponsor

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