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The PREVAIL Study (PREVAIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03260517
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
In-stent Restenosis Ischemic Heart Disease Coronary Artery Disease Device: Medtronic Coronary Drug-Coated Balloon Catheter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : January 29, 2019
Estimated Study Completion Date : August 25, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260517


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

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT03260517     History of Changes
Other Study ID Numbers: MDT17027DCB001
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases