The PREVAIL Study

Study Overview
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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.

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.

Official Title
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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

Conditions
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In-stent Restenosis, Ischemic Heart Disease, Coronary Artery Disease

Intervention / Treatment
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* Device: Medtronic Coronary Drug-Coated Balloon Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm (Mdt Drug-Coated Balloon)<br>Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion. | Device: Medtronic Coronary Drug-Coated Balloon Catheter<br>* Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 6 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All deaths including cardiac death.procedure | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 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 | 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 | 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 | 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. | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure | 
| All revascularizations (TLR, TVR and non-TVR). | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 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). | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure | 
| Acute success (device, lesion and procedure success). | Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure | 30 days, 6 months and 1 year after procedure |