The PREVAIL Study

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; In-stent Restenosis; Coronary Artery Disease
• Interventions: Device: Medtronic Coronary Drug-Coated Balloon Catheter

• Registration Number: NCT03260517
• Lead Sponsor: Medtronic Vascular

Brief 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.

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.

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-24
• Study Start: 2017-10-02
• Primary Completion: 2019-01-29
• Study Completion: 2019-08-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm (Mdt Drug-Coated Balloon)	Medtronic Coronary Drug-Coated Balloon Catheter	Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion.

Primary Outcome Measures

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

Name	Time	Method
All deaths including cardiac death.procedure	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)	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	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.	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.	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).	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).	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).	30 days, 6 months and 1 year after procedure	Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure

Trial Locations

Locations (10)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Ospedale San Raffaele; 🇮🇹 Milano, Italy

ZNA Middelheim; 🇧🇪 Antwerp, Belgium

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Haga Ziekenhuis locatie Leyweg; 🇳🇱 Den Haag, Netherlands

IRCCS Policlinico San Donato; 🇮🇹 Milano, Italy

CHU Liege; 🇧🇪 Liège, Belgium

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Netherlands