Comparing Agent DCB with Prevail DCB for coronary artery disease
Official title: Prevail Global Study
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).
- 2 groups
- Sites in Montreal, Ottawa and 2 more cities
- Recruiting
Interventions
- Medical 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.
- Medical device
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).
Canadian Sites (5)
5 of 5 recruiting
- Recruiting
Hôpital du Sacre Coeur de Montreal
Montreal
- Recruiting
Montreal Heart Institute
Montreal
- Recruiting
University of Ottawa Heart Institute
Ottawa
- Recruiting
Toronto General Hospital
Toronto
- Recruiting
Vancouver General Hospital
Vancouver
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +≥ 18 years
- +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 upFollow-upContinued check-ins after the treatment part is finished.Read more → evaluations
- +Negative pregnancy test
Exclusion
- −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)
- −Previous PCI of the target vessel within 6 months prior to the procedure
- −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%
- −Currently participating in an investigational drug or another device study that has not completed the primary endpointPrimary endpointThe single main question the study is designed to answer.Read more → or that clinically interferes with the current study endpointsEndpointThe specific thing a study measures to answer its question.Read more →; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures
- −Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Prevail DCB, together with one or more of: Agent DCB.
Registry label: A: ISR Cohort Prevail DCB
Group B receives Prevail DCB.
Registry label: B: DNSV Cohort (RVD 2.0 - 2.75mm)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,205 people.
The study is currently expected to finish around February 2031.
The main measurement is taken over: 1 year post-procedure.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
ISR CohortCohortA group of participants sharing a characteristic, followed together.Read more → Primary Analysis — measured over 1 year post-procedure.
DNSV Cohort Primary Analysis — measured over 1 year post-procedure.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06535854 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About 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).
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year post-procedure.
The study as a whole is currently expected to finish around 2031-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,205 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Montreal, Canada; Ottawa, Canada; Toronto, Canada; Vancouver, Canada; Ann Arbor, Michigan, United States; Grand Rapids, Michigan, United States, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Other Sites (13)
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 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
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
CentraCare Heart & Vascular Center MN - Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Providence Saint Patrick Hospital
Missoula, Montana, United States
Kaleida Health
Buffalo, New York, United States
Northwell Health North Shore University Hospital
Manhasset, 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
University of Washington (UW) Medical Center
Seattle, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.