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NCT06535854ClinicalTrials.gov

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).

RecruitingTaking participants now, according to the registry record.
Contact this study

In brief

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Interventional1,205 participants sought51 sites1 country

Categories

Cardiovascular100%

Registered in 1 registry

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2024-08-02; recorded start 2025-02-24
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 10 other studies in this databaseCounted from the lead sponsor named in the record (Medtronic Vascular)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding7/20

    Single-blind

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 51 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,205 participants (target), run at 51 sites.

How this score is built
  • Enrolment31/40

    1,205 participants (target)

  • Site count20/25

    51 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 72 months

  • Sponsor scale3/10

    Medtronic Vascular has led 11 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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 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

  • Coronary Artery Disease

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

Inclusion Criteria: * ≥ 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 Exclusion Criteria: * 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 * 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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhaseNot applicable
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingSINGLE (1)
Enrolment1,205 participants sought

Sponsor and collaborators

  • Medtronic Vascular Sponsor

Arms and interventions

  • ISR Cohort Prevail DCBEXPERIMENTAL

    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.

  • 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.

Interventions

  • 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).

  • 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.

Outcome measures

  1. Primary outcome

    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

  2. Primary outcome

    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

  3. Secondary outcome

    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

  4. Secondary outcome

    All deaths

    Time frame hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  5. Secondary outcome

    Cardiac death

    Time frame hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  6. Secondary outcome

    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

  7. Secondary outcome

    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

  8. Secondary outcome

    Clinically-driven target vessel revascularization (cd-TVR)

    Time frame hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  9. Secondary outcome

    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

  10. Secondary outcome

    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

  11. Secondary outcome

    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

  12. Secondary outcome

    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

Dates

Start dateFebruary 24, 2025 (actual)
Primary completionFebruary 1, 2027 (estimated)
CompletionFebruary 1, 2031 (estimated)
First postedAugust 2, 2024 (actual)
Last updatedApril 24, 2026
Results postedNot stated in the registry record
Status last verifiedApril 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

51 sites are recruiting

United States

FacilityCityState or regionStatus
Lehigh Valley Hospital - Cedar CrestAllentownPennsylvaniaRecruiting
AnMed Health Medical CenterAndersonSouth CarolinaRecruiting
University of Michigan Health System - University HospitalAnn ArborMichiganRecruiting
Piedmont Atlanta HospitalAtlantaGeorgiaRecruiting
Emory University Hospital MidtownAtlantaGeorgiaRecruiting
The University of Alabama at BirminghamBirminghamAlabamaRecruiting
Kaleida HealthBuffaloNew YorkRecruiting
Virtua Our Lady of Lourdes HospitalCamdenNew JerseyRecruiting
Medical University of South Carolina (MUSC)CharlestonSouth CarolinaRecruiting
Advocate Illinois Masonic Medical CenterChicagoIllinoisRecruiting
The Lindner Research CenterCincinnatiOhioRecruiting
BayCare Health SystemClearwaterFloridaRecruiting
University Hospitals Cleveland Medical CenterClevelandOhioRecruiting
OhioHealth Riverside Methodist HospitalColumbusOhioRecruiting
Baylor Heart & Vascular HospitalDallasTexasRecruiting
Saint Elizabeth HealthcareEdgewoodKentuckyRecruiting
M Health Fairview ClinicEdinaMinnesotaRecruiting
Parkview HealthFort WayneIndianaRecruiting
North Florida Regional Medical CenterGainesvilleFloridaRecruiting
Corewell HealthGrand RapidsMichiganRecruiting
The Moses H Cone Memorial HospitalGreensboroNorth CarolinaRecruiting
UPMC Pinnacle Harrisburg CampusHarrisburgPennsylvaniaRecruiting
HCA Houston Medical CenterHoustonTexasRecruiting
Huntsville HospitalHuntsvilleAlabamaRecruiting
University of Kansas Medical CenterKansas CityKansasRecruiting
Saint Lukes Mid America Heart InstituteKansas CityMissouriRecruiting
Gundersen LutheranLa CrosseWisconsinRecruiting
John L McClellan Memorial Veterans HospitalLittle RockArkansasRecruiting
Medical Center of the RockiesLovelandColoradoRecruiting
University of Miami HospitalMiamiFloridaRecruiting
Providence Saint Patrick HospitalMissoulaMontanaRecruiting
Midwest Cardiovascular InstituteNapervilleIllinoisRecruiting
Vanderbilt University Medical CenterNashvilleTennesseeRecruiting
TriStar Centennial Medical CenterNashvilleTennesseeRecruiting
Montefiore Medical CenterNew YorkNew YorkRecruiting
Cumc/NyphNew YorkNew YorkRecruiting
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)Overland ParkKansasRecruiting
The Valley HospitalParamusNew JerseyRecruiting
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvaniaRecruiting
The Heart Hospital Baylor PlanoPlanoTexasRecruiting
Oregon Health & Science University HospitalPortlandOregonRecruiting
Rhode Island Hospital and Health Services - LifespanProvidenceRhode IslandRecruiting
Saint Francis Hospital (Roslyn NY)RoslynNew YorkRecruiting
CentraCare Heart & Vascular Center MN - Saint Cloud HospitalSaint CloudMinnesotaRecruiting
University of Washington (UW) Medical CenterSeattleWashingtonRecruiting
Stanford Hospital & ClinicsStanfordCaliforniaRecruiting
Carondelet Saint MarysTucsonArizonaRecruiting
Medstar Washington Hospital CenterWashington D.C.District of ColumbiaRecruiting
Ascension Via Christi Saint FrancisWichitaKansasRecruiting
Novant Health New Hanover Regional Medical CenterWilmingtonNorth CarolinaRecruiting

1 further site is listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06535854