Coronary Artery DiseaseNCT06535854
Prevail Global Study
A study testing Prevail DCB and Agent DCB in people with Coronary Artery Disease, run by Medtronic Vascular at 79 sites in 9 countries.
Trial summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prevail DCB and Agent DCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,205 participants
- Where
- 79 sitesin 9 countries
- Study dates
- 24 Feb 2025to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- 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
Who cannot join
- Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
- 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
Show all 13Show fewer
- Planned PCI of any vessel within 72 hours 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
Trial locations and contacts
79 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
79 sites in 9 countries
United States55 sites, 54 recruiting
- Recruiting
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18103
Shai Singh
- Recruiting
AnMed Health Medical Center
Anderson, South Carolina, 29621
John Meehan
- Recruiting
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109
Daniel Menees
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Pratik Sandesara
- Recruiting
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Prashant Kaul
- Recruiting
Cardiology P.C.
Birmingham, Alabama, 35211
Tushar Mishra
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Mustafa Ahmed
- Recruiting
Kaleida Health
Buffalo, New York, 14214
Vijay Iyer
- Recruiting
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, 08103
Kintur Sanghvi
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Christopher Nielsen
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Joaquin Gonzalez
- Recruiting
The Lindner Research Center
Cincinnati, Ohio, 45219
Jarrod Frizzell
- Recruiting
BayCare Health System
Clearwater, Florida, 33756
Parag Patel
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Anjan Gupta
- Recruiting
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Arash Arshi
- Recruiting
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
Robert Stoler
- Recruiting
Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017
Mohan Brar
- Withdrawn
M Health Fairview Clinic
Edina, Minnesota, 55435
- Recruiting
Parkview Health
Fort Wayne, Indiana, 46845
Peter Chaille
- Recruiting
North Florida Regional Medical Center
Gainesville, Florida, 32605
Mark Tulli
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Araya Negash
- Recruiting
The Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27401
Muhammad Arida
- Recruiting
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
Randolph Hubbard
- Recruiting
HCA Houston Medical Center
Houston, Texas, 77004
Pranav Loyalka
- Recruiting
Huntsville Hospital
Huntsville, Alabama, 35801
Michael Butler
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Anthony (Tony) Spaedy
- Recruiting
Saint Lukes Mid America Heart Institute
Kansas City, Missouri, 64111
Dany Jacob
- Recruiting
Gundersen Lutheran
La Crosse, Wisconsin, 54601
Wah Wah Htun
- Recruiting
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, 72205
Barry Uretsky
- Recruiting
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205
Sean Stewart
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Shivanshu Madan
- Recruiting
Northwell Health North Shore University Hospital
Manhasset, New York, 11030
Avneet Singh
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
Yiannis Chatzizisis
- Recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Konstantinos Voudris
- Recruiting
Providence Saint Patrick Hospital
Missoula, Montana, 59802
Michael Reed
- Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
Osama Qaqi
- Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Brian Jefferson
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Colin Barker
- Recruiting
Cumc/Nyph
New York, New York, 10032
Ajay Kirtane
- Recruiting
Montefiore Medical Center
New York, New York, 10467
Andrea Mignatti
- Recruiting
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Overland Park, Kansas, 66211
Jayasheel Eshcol
- Recruiting
The Valley Hospital
Paramus, New Jersey, 07652
Kimberley Michel
Rajiv Tayal
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Taisei Kobayashi
- Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Sibi Thomas
- Recruiting
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Firas Zahr
- Recruiting
Rhode Island Hospital and Health Services - Lifespan
Providence, Rhode Island, 02903
Saraschandra Vallabhajosyula
- Recruiting
Saint Francis Hospital (Roslyn NY)
Roslyn, New York, 11576
Elizabeth Haag
Marion Cyriac
- Recruiting
CentraCare Heart & Vascular Center MN - Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Stephen Kidd
- Recruiting
University of Washington (UW) Medical Center
Seattle, Washington, 98195
Lorenzo Azzalini
- Recruiting
Stanford Hospital & Clinics
Stanford, California, 94305
Jennifer Tremmel
- Recruiting
Carondelet Saint Marys
Tucson, Arizona, 85745
Kapil Lotun
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Hayder Hashim
- Recruiting
Ascension Via Christi Saint Francis
Wichita, Kansas, 67214
Bassem Chehab
- Recruiting
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Sunil Iyer
- Recruiting
Saint Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
Mansoor Qureshi
Canada5 sites, 5 recruiting
- Recruiting
Hôpital du Sacre Coeur de Montreal
Montreal
Raja Hatem
- Recruiting
Montreal Heart Institute
Montreal
Guillaume Marquis-Gravel
- Recruiting
University of Ottawa Heart Institute
Ottawa
Derek So
- Recruiting
Toronto General Hospital
Toronto
Sanjog Kalra
- Recruiting
Vancouver General Hospital
Vancouver
David Wood
Japan5 sites, 5 recruiting
- Recruiting
Teikyo University Hospital
Itabashi-ku, Tokyo
Yusuke Watanabe
- Recruiting
Shonan Kamakura General Hospital
Kamakura, Kanagawa
Shigeru Saito
- Recruiting
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Kenji Ando
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi
Shintaro Honda
- Recruiting
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa
Ito Yoshiaki
South Korea5 sites, 5 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu
Yoon Hyuck Jun
- Recruiting
Asan Medical Center
Seoul
DukWoo Park
- Recruiting
Korea University Anam Hospital
Seoul
Soon Jun Hong
- Recruiting
Seoul National University Hospital
Seoul
Koo Bon Kwon
- Recruiting
Seoul Saint Marys Hospital
Seoul
Byung-Hee Hwang
Germany3 sites, 3 recruiting
- Recruiting
Herzzentrum Dresden GmbH Universitätsklinik
Dresden
Norman Mangner
- Recruiting
Universitat des Saarlandes
Homburg
Bruno Scheller
- Recruiting
MediClin Herzzentrum Lahr / Baden
Lahr
Kambis Mashayekhi
Ireland2 sites, 2 recruiting
- Recruiting
Mater Private Network
Dublin
Robert Byrne
- Recruiting
Galway University Hospitals - University Hospital Galway (UHG)
Galway
Darren Mylotte
Singapore2 sites, 2 recruiting
- Recruiting
Sengkang General Hospital
Singapore
Jack Wei Chieh Tan
- Recruiting
Tan Tock Seng Hospital
Singapore
Fahim Haider Jafary
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Frankie Tam
United Kingdom1 site, 1 recruiting
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne
Azfar Zaman
About this study
Official title: A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Read the detailed description
The Prevail Global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent restenosis (ISR Cohort) in a randomized controlled study of the Prevail Drug-Coated Balloon, and subjects undergoing percutaneous coronary intervention of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (DNSV Cohort) in a single arm prospectively enrolled study.
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 85 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
- Coronary Artery Disease
- Being tested
- Prevail DCB, Agent DCB
- Keywords
- ISR, DNSV
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevail DCBDevice
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 DCBDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| ISR Cohort Prevail DCB | Experimental | 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. Receives: Device: Prevail DCB; Device: Agent DCB |
| DNSV Cohort (RVD 2.0 - 2.75mm) | Experimental | 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. Receives: Device: Prevail DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISR Cohort Primary Analysis
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority
Measured: 1 year post-procedure
DNSV Cohort Primary Analysis
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control
Measured: 1 year post-procedure
Secondary outcomes (10)
Acute success
Acute success (device, lesion, and procedure) through hospital discharge only
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All deaths
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Cardiac death
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Clinically-driven target vessel revascularization (cd-TVR)
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition
Measured: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start24 Feb 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kandzari, Principal investigator, Piedmont Heart InstituteBruno Scheller, Principal investigator, University of SaarlandAzeem Latib, Principal investigator, Montefiore Health SystemDarren Mylotte, Principal investigator, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535854
- Sponsor's protocol ID
- MDT22021
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39863032
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).
- ClinicalTrials.gov ID
- NCT06535854
- Acronym / sponsor ID
- MDT22021
- Conditions
- Coronary Artery Disease
- Keywords
- ISR, DNSV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,205 participants (estimated)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Detailed description
The Prevail Global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent restenosis (ISR Cohort) in a randomized controlled study of the Prevail Drug-Coated Balloon, and subjects undergoing percutaneous coronary intervention of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (DNSV Cohort) in a single arm prospectively enrolled study.
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 85 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISR Cohort Prevail DCB | Experimental | Device: Prevail DCB, Device: Agent DCBTo 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. |
| DNSV Cohort (RVD 2.0 - 2.75mm) | Experimental | Device: Prevail DCBTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years
- 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
Key exclusion criteria (13 listed)
- Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevail DCBThe 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. | Device | DNSV Cohort (RVD 2.0 - 2.75mm), ISR Cohort Prevail DCB |
| Agent DCBThe 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). | Device | ISR Cohort Prevail DCB |
Primary outcome
ISR Cohort Primary Analysis
Time frame: 1 year post-procedure
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority
DNSV Cohort Primary Analysis
Time frame: 1 year post-procedure
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control
10 secondary outcomes
Acute success
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All deaths
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Cardiac death
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Clinically-driven target vessel revascularization (cd-TVR)
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition
Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Derived from this study: PubMed 39863032Kandzari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Kandzari principal investigator
Piedmont Heart Institute
Bruno Scheller principal investigator
University of Saarland
Azeem Latib principal investigator
Montefiore Health System
79 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevail DCB and Agent DCB in people with Coronary Artery Disease, run by Medtronic Vascular at 79 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Canada, Japan, South Korea, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Frijhoff (+31 (0)43.356.6566, rs.prevailglobal@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ISR Cohort Primary Analysis (time frame: 1 year post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.