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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).

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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

Interventistico1205 partecipanti ricercati51 centri1 paese

Categorie

Cardiovascolare100%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Coronary Artery Disease

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel registro

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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseNon applicabile
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoSINGLE (1)
Arruolamento1205 partecipanti ricercati

Sponsor e collaboratori

  • Medtronic Vascular Sponsor

Bracci e interventi

  • 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.

Interventi

  • Dispositivo 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).

  • Dispositivo 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.

Esiti misurati

  1. Esito primario

    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

    Orizzonte temporale 1 year post-procedure

  2. Esito primario

    DNSV Cohort Primary Analysis

    The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control

    Orizzonte temporale 1 year post-procedure

  3. Esito secondario

    Acute success

    Acute success (device, lesion, and procedure) through hospital discharge only

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  4. Esito secondario

    All deaths

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  5. Esito secondario

    Cardiac death

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  6. Esito secondario

    All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  7. Esito secondario

    Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  8. Esito secondario

    Clinically-driven target vessel revascularization (cd-TVR)

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  9. Esito secondario

    Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  10. Esito secondario

    Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  11. Esito secondario

    Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  12. Esito secondario

    Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition

    Orizzonte temporale hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

Date

Data di inizio24 febbraio 2025 (effettiva)
Conclusione primaria1 febbraio 2027 (stimata)
Conclusione1 febbraio 2031 (stimata)
Prima pubblicazione2 agosto 2024 (effettiva)
Ultimo aggiornamento24 aprile 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaaprile 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

51 centri stanno reclutando

United States

StrutturaCittàStato o regioneStato
Lehigh Valley Hospital - Cedar CrestAllentownPennsylvaniaIn reclutamento
AnMed Health Medical CenterAndersonSouth CarolinaIn reclutamento
University of Michigan Health System - University HospitalAnn ArborMichiganIn reclutamento
Piedmont Atlanta HospitalAtlantaGeorgiaIn reclutamento
Emory University Hospital MidtownAtlantaGeorgiaIn reclutamento
The University of Alabama at BirminghamBirminghamAlabamaIn reclutamento
Kaleida HealthBuffaloNew YorkIn reclutamento
Virtua Our Lady of Lourdes HospitalCamdenNew JerseyIn reclutamento
Medical University of South Carolina (MUSC)CharlestonSouth CarolinaIn reclutamento
Advocate Illinois Masonic Medical CenterChicagoIllinoisIn reclutamento
The Lindner Research CenterCincinnatiOhioIn reclutamento
BayCare Health SystemClearwaterFloridaIn reclutamento
University Hospitals Cleveland Medical CenterClevelandOhioIn reclutamento
OhioHealth Riverside Methodist HospitalColumbusOhioIn reclutamento
Baylor Heart & Vascular HospitalDallasTexasIn reclutamento
Saint Elizabeth HealthcareEdgewoodKentuckyIn reclutamento
M Health Fairview ClinicEdinaMinnesotaIn reclutamento
Parkview HealthFort WayneIndianaIn reclutamento
North Florida Regional Medical CenterGainesvilleFloridaIn reclutamento
Corewell HealthGrand RapidsMichiganIn reclutamento
The Moses H Cone Memorial HospitalGreensboroNorth CarolinaIn reclutamento
UPMC Pinnacle Harrisburg CampusHarrisburgPennsylvaniaIn reclutamento
HCA Houston Medical CenterHoustonTexasIn reclutamento
Huntsville HospitalHuntsvilleAlabamaIn reclutamento
University of Kansas Medical CenterKansas CityKansasIn reclutamento
Saint Lukes Mid America Heart InstituteKansas CityMissouriIn reclutamento
Gundersen LutheranLa CrosseWisconsinIn reclutamento
John L McClellan Memorial Veterans HospitalLittle RockArkansasIn reclutamento
Medical Center of the RockiesLovelandColoradoIn reclutamento
University of Miami HospitalMiamiFloridaIn reclutamento
Providence Saint Patrick HospitalMissoulaMontanaIn reclutamento
Midwest Cardiovascular InstituteNapervilleIllinoisIn reclutamento
Vanderbilt University Medical CenterNashvilleTennesseeIn reclutamento
TriStar Centennial Medical CenterNashvilleTennesseeIn reclutamento
Montefiore Medical CenterNew YorkNew YorkIn reclutamento
Cumc/NyphNew YorkNew YorkIn reclutamento
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)Overland ParkKansasIn reclutamento
The Valley HospitalParamusNew JerseyIn reclutamento
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvaniaIn reclutamento
The Heart Hospital Baylor PlanoPlanoTexasIn reclutamento
Oregon Health & Science University HospitalPortlandOregonIn reclutamento
Rhode Island Hospital and Health Services - LifespanProvidenceRhode IslandIn reclutamento
Saint Francis Hospital (Roslyn NY)RoslynNew YorkIn reclutamento
CentraCare Heart & Vascular Center MN - Saint Cloud HospitalSaint CloudMinnesotaIn reclutamento
University of Washington (UW) Medical CenterSeattleWashingtonIn reclutamento
Stanford Hospital & ClinicsStanfordCaliforniaIn reclutamento
Carondelet Saint MarysTucsonArizonaIn reclutamento
Medstar Washington Hospital CenterWashington D.C.District of ColumbiaIn reclutamento
Ascension Via Christi Saint FrancisWichitaKansasIn reclutamento
Novant Health New Hanover Regional Medical CenterWilmingtonNorth CarolinaIn reclutamento

Nella scheda del registro è indicato 1 altro centro.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

Registro: ClinicalTrials.gov · NCT########

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