The PREVAIL Study

Coronary Artery Disease Clinical Trial

— PREVAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260517
• Other study ID #: MDT17027DCB001
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: September 2019
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• In-stent Restenosis
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerp
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	CHU Liege	Liège
Italy	IRCCS Policlinico San Donato	Milano
Italy	Ospedale San Raffaele	Milano
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Haga Ziekenhuis locatie Leyweg	Den Haag
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In-stent (balloon) and in-segment LLL	Angiographic Endpoints to be assessed at 6 months post-procedure	6 months post-procedure
Other	In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)).	Angiographic Endpoints to be assessed at 6 months post-procedure	6 months post-procedure
Other	In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as =50% diameter stenosis (DS)].	Angiographic Endpoints to be assessed at 6 months post-procedure	6 months post-procedure
Other	In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD).	Angiographic Endpoints to be assessed at 6 months post-procedure	6 months post-procedure
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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