Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1205 participants
INTERVENTIONAL
2025-02-24
2031-02-28
Brief Summary
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Detailed Description
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In the ISR Cohort this will be accomplished by randomizing subjects to either a Prevail DCB arm or an Agent DCB arm to compare results of the treatment of ISR with coronary lesions previously treated with DES or BMS in native coronary arteries. In the DNSV Cohort this will be accomplished through collection of data to compare results of the Prevail DCB to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.
Subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. The enrollment period is anticipated to be approximately 12 months. Subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Subjects in DNSV Cohort will be prospectively enrolled in the study and treated with Prevail DCB.
Study Groups
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ISR Cohort Prevail DCB
To evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
Prevail DCB
The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.
Agent DCB
The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).
DNSV Cohort (RVD 2.0 - 2.75mm)
To evaluate the clinical safety and efficacy of the Prevail DCB as compared to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.
Prevail DCB
The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.
Interventions
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Prevail DCB
The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.
Agent DCB
The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).
Eligibility Criteria
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Inclusion Criteria
* Negative pregnancy test
* Stable or unstable angina, positive functional test, or stable NSTEMI
* Life expectancy \>1 year
* Willing and able to cooperate with study procedures and required follow up evaluations
Exclusion Criteria
* History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
* Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
* Renal insufficiency (or failure)
* Acute MI
* Previous PCI of the target vessel within 6 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
* History of a stroke or transient ischemic attack (TIA)
* Active peptic ulcer or upper gastrointestinal (GI) bleeding
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Documented left ventricular ejection fraction (LVEF) \<30%
* Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
* Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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David Kandzari
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Bruno Scheller
Role: PRINCIPAL_INVESTIGATOR
University of Saarland
Azeem Latib
Role: PRINCIPAL_INVESTIGATOR
Montefiore Health System
Darren Mylotte
Role: PRINCIPAL_INVESTIGATOR
Galway University Hospitals
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Carondelet Saint Marys
Tucson, Arizona, United States
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
Stanford Hospital & Clinics
Stanford, California, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
BayCare Health System
Clearwater, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Parkview Health
Fort Wayne, Indiana, United States
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Overland Park, Kansas, United States
Ascension Via Christi Saint Francis
Wichita, Kansas, United States
Saint Elizabeth Healthcare
Edgewood, Kentucky, United States
Corewell Health
Grand Rapids, Michigan, United States
Saint Joseph Mercy Ann Arbor
Ypsilanti, Michigan, United States
M Health Fairview Clinic
Edina, Minnesota, United States
CentraCare Heart & Vascular Center MN - Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Saint Lukes Mid America Heart Institute
Kansas City, Missouri, United States
Providence Saint Patrick Hospital
Missoula, Montana, United States
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, United States
The Valley Hospital
Paramus, New Jersey, United States
Kaleida Health
Buffalo, New York, United States
Cumc/Nyph
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Saint Francis Hospital (Roslyn NY)
Roslyn, New York, United States
The Moses H Cone Memorial Hospital
Greensboro, North Carolina, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
The Lindner Research Center
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States
Rhode Island Hospital and Health Services - Lifespan
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
HCA Houston Medical Center
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Kimberley Michel
Role: primary
Katie Dalton
Role: primary
Elizabeth Haag
Role: primary
Marion Cyriac
Role: backup
References
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Kandzari DE, Latib A, Mylotte D, Ali ZA, Zaman A, Brar S, Parke M, Scheller B. Rationale and design of the prevail global trial program evaluating the prevail drug-coated balloon in patients with in-stent restenosis and de novo small vessel disease. Am Heart J. 2025 May;283:26-36. doi: 10.1016/j.ahj.2025.01.010. Epub 2025 Jan 23.
Other Identifiers
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MDT22021
Identifier Type: -
Identifier Source: org_study_id
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