The PREVAIL Study (PREVAIL)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; In-stent Restenosis
• Intervention / Treatment: Device: Medtronic Coronary Drug-Coated Balloon Catheter

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Liège, Belgium, 4000
    • Chu Liege
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele
  • Milano, Italy, 20097
    • IRCCS Policlinico San Donato
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis
  • Den Haag, Netherlands, 2545 AA
    • Haga Ziekenhuis locatie Leyweg
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius ziekenhuis
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
  • Zwolle, Netherlands, 8025 AB
    • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent (balloon) and in-segment LLL	Angiographic Endpoints to be assessed at 6 months post-procedure	6 months post-procedure
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
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
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

Collaborators and Investigators

• Sponsor: Medtronic Vascular

Publications and helpful links

General Publications

• Grosso A, Neves de Faria RI, Bojke L, Donohue C, Fraser CI, Harron KL, Oddie SJ, Gilbert R. Cost-effectiveness of strategies preventing late-onset infection in preterm infants. Arch Dis Child. 2020 May;105(5):452-457. doi: 10.1136/archdischild-2019-317640. Epub 2019 Dec 13. Erratum In: Arch Dis Child. 2021 Jan;106(1):e1.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): January 29, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: MDT17027DCB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No