An interventional study of Prevail DCB and Agent DCB in Coronary Artery Disease, sponsored by Medtronic Vascular. Recruiting at 79 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Medtronic Vascular (part of Medtronic) · Not applicable, Interventional, and Treatment
Canada, Germany, Hong Kong, Ireland, Japan, Singapore, South Korea, United Kingdom
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 1,205 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 21, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Prevail DCB · Device: Agent DCB
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.
Device: 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.
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).
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
Time frame: 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
Time frame: 1 year post-procedure
Acute success
Acute success (device, lesion, and procedure) through hospital discharge only
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
Not enrolling at this site — choose another above.
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.
Of 177 industry-sponsored interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 40. This study's planned 24 months is close to that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
Canada, Germany, Hong Kong, Ireland, Japan, Singapore, South Korea, United Kingdom
Canada, Germany, Hong Kong, Ireland, Japan, Singapore, South Korea, United Kingdom
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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