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).

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

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

Interventionnelle1 205 participants recherchés51 sites1 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

ClinicalTrials.govNCT06535854Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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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.

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

Résumé

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.

Affections

Coronary Artery Disease

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Sans objet
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	SINGLE (1)
Recrutement	1 205 participants recherchés

Promoteur et collaborateurs

Medtronic Vascular Promoteur

Groupes et 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

Dispositif 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).
Dispositif 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.

Critères de jugement

Critère de jugement principal
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
Délai 1 year post-procedure
Critère de jugement principal
DNSV Cohort Primary Analysis
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control
Délai 1 year post-procedure
Critère de jugement secondaire
Acute success
Acute success (device, lesion, and procedure) through hospital discharge only
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
All deaths
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
Cardiac death
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
Clinically-driven target vessel revascularization (cd-TVR)
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Critère de jugement secondaire
Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition
Délai hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

Dates

Dates
Date de début	24 février 2025 (réelle)
Achèvement principal	1 février 2027 (estimée)
Achèvement	1 février 2031 (estimée)
Première publication	2 août 2024 (réelle)
Dernière mise à jour	24 avril 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	avril 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

51 sites sont en recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	En recrutement
AnMed Health Medical Center	Anderson	South Carolina	En recrutement
University of Michigan Health System - University Hospital	Ann Arbor	Michigan	En recrutement
Piedmont Atlanta Hospital	Atlanta	Georgia	En recrutement
Emory University Hospital Midtown	Atlanta	Georgia	En recrutement
The University of Alabama at Birmingham	Birmingham	Alabama	En recrutement
Kaleida Health	Buffalo	New York	En recrutement
Virtua Our Lady of Lourdes Hospital	Camden	New Jersey	En recrutement
Medical University of South Carolina (MUSC)	Charleston	South Carolina	En recrutement
Advocate Illinois Masonic Medical Center	Chicago	Illinois	En recrutement
The Lindner Research Center	Cincinnati	Ohio	En recrutement
BayCare Health System	Clearwater	Florida	En recrutement
University Hospitals Cleveland Medical Center	Cleveland	Ohio	En recrutement
OhioHealth Riverside Methodist Hospital	Columbus	Ohio	En recrutement
Baylor Heart & Vascular Hospital	Dallas	Texas	En recrutement
Saint Elizabeth Healthcare	Edgewood	Kentucky	En recrutement
M Health Fairview Clinic	Edina	Minnesota	En recrutement
Parkview Health	Fort Wayne	Indiana	En recrutement
North Florida Regional Medical Center	Gainesville	Florida	En recrutement
Corewell Health	Grand Rapids	Michigan	En recrutement
The Moses H Cone Memorial Hospital	Greensboro	North Carolina	En recrutement
UPMC Pinnacle Harrisburg Campus	Harrisburg	Pennsylvania	En recrutement
HCA Houston Medical Center	Houston	Texas	En recrutement
Huntsville Hospital	Huntsville	Alabama	En recrutement
University of Kansas Medical Center	Kansas City	Kansas	En recrutement
Saint Lukes Mid America Heart Institute	Kansas City	Missouri	En recrutement
Gundersen Lutheran	La Crosse	Wisconsin	En recrutement
John L McClellan Memorial Veterans Hospital	Little Rock	Arkansas	En recrutement
Medical Center of the Rockies	Loveland	Colorado	En recrutement
University of Miami Hospital	Miami	Florida	En recrutement
Providence Saint Patrick Hospital	Missoula	Montana	En recrutement
Midwest Cardiovascular Institute	Naperville	Illinois	En recrutement
Vanderbilt University Medical Center	Nashville	Tennessee	En recrutement
TriStar Centennial Medical Center	Nashville	Tennessee	En recrutement
Montefiore Medical Center	New York	New York	En recrutement
Cumc/Nyph	New York	New York	En recrutement
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)	Overland Park	Kansas	En recrutement
The Valley Hospital	Paramus	New Jersey	En recrutement
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	En recrutement
The Heart Hospital Baylor Plano	Plano	Texas	En recrutement
Oregon Health & Science University Hospital	Portland	Oregon	En recrutement
Rhode Island Hospital and Health Services - Lifespan	Providence	Rhode Island	En recrutement
Saint Francis Hospital (Roslyn NY)	Roslyn	New York	En recrutement
CentraCare Heart & Vascular Center MN - Saint Cloud Hospital	Saint Cloud	Minnesota	En recrutement
University of Washington (UW) Medical Center	Seattle	Washington	En recrutement
Stanford Hospital & Clinics	Stanford	California	En recrutement
Carondelet Saint Marys	Tucson	Arizona	En recrutement
Medstar Washington Hospital Center	Washington D.C.	District of Columbia	En recrutement
Ascension Via Christi Saint Francis	Wichita	Kansas	En recrutement
Novant Health New Hanover Regional Medical Center	Wilmington	North Carolina	En recrutement

1 site supplémentaire est indiqué dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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