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Completed

NCT Number: NCT03260517

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.

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Key information

Conditions

In-Stent Restenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZNA Middelheim, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic Coronary Drug-Coated Balloon Catheter

Device

Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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. 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

  6. 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

  7. 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

  8. 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

Other outcomes

  1. In-stent (balloon) and in-segment LLL

    Time frame: 6 months post-procedure

    Angiographic Endpoints to be assessed at 6 months post-procedure

  2. In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)).

    Time frame: 6 months post-procedure

    Angiographic Endpoints to be assessed at 6 months post-procedure

  3. In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)].

    Time frame: 6 months post-procedure

    Angiographic Endpoints to be assessed at 6 months post-procedure

  4. In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD).

    Time frame: 6 months post-procedure

    Angiographic Endpoints to be assessed at 6 months post-procedure

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study 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

Acronym: PREVAIL

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2017
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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