xMedica

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).

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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

התערבותידרושים 1,205 משתתפים51 אתריםמדינה אחת

קטגוריות

לב וכלי דם100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Coronary Artery Disease

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבלא רלוונטי
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהSINGLE (1)
גיוסדרושים 1,205 משתתפים

נותן חסות ושותפים

  • Medtronic Vascular נותן חסות

זרועות והתערבויות

  • 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.

התערבויות

  • התקן 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).

  • התקן 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.

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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

    מסגרת זמן 1 year post-procedure

  2. מדד תוצאה ראשוני

    DNSV Cohort Primary Analysis

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

    מסגרת זמן 1 year post-procedure

  3. מדד תוצאה משני

    Acute success

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

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  4. מדד תוצאה משני

    All deaths

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  5. מדד תוצאה משני

    Cardiac death

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  6. מדד תוצאה משני

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

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  7. מדד תוצאה משני

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

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  8. מדד תוצאה משני

    Clinically-driven target vessel revascularization (cd-TVR)

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  9. מדד תוצאה משני

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

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  10. מדד תוצאה משני

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

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  11. מדד תוצאה משני

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

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  12. מדד תוצאה משני

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

    מסגרת זמן hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

תאריכים

תאריך התחלה24 בפברואר 2025 (בפועל)
סיום ראשוני1 בפברואר 2027 (משוער)
סיום1 בפברואר 2031 (משוער)
פורסם לראשונה2 באוגוסט 2024 (בפועל)
עודכן לאחרונה24 באפריל 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהאפריל 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

51 אתרים מגייסים

United States

מתקןעירמדינה או אזורמצב
Lehigh Valley Hospital - Cedar CrestAllentownPennsylvaniaמגייס
AnMed Health Medical CenterAndersonSouth Carolinaמגייס
University of Michigan Health System - University HospitalAnn ArborMichiganמגייס
Piedmont Atlanta HospitalAtlantaGeorgiaמגייס
Emory University Hospital MidtownAtlantaGeorgiaמגייס
The University of Alabama at BirminghamBirminghamAlabamaמגייס
Kaleida HealthBuffaloNew Yorkמגייס
Virtua Our Lady of Lourdes HospitalCamdenNew Jerseyמגייס
Medical University of South Carolina (MUSC)CharlestonSouth Carolinaמגייס
Advocate Illinois Masonic Medical CenterChicagoIllinoisמגייס
The Lindner Research CenterCincinnatiOhioמגייס
BayCare Health SystemClearwaterFloridaמגייס
University Hospitals Cleveland Medical CenterClevelandOhioמגייס
OhioHealth Riverside Methodist HospitalColumbusOhioמגייס
Baylor Heart & Vascular HospitalDallasTexasמגייס
Saint Elizabeth HealthcareEdgewoodKentuckyמגייס
M Health Fairview ClinicEdinaMinnesotaמגייס
Parkview HealthFort WayneIndianaמגייס
North Florida Regional Medical CenterGainesvilleFloridaמגייס
Corewell HealthGrand RapidsMichiganמגייס
The Moses H Cone Memorial HospitalGreensboroNorth Carolinaמגייס
UPMC Pinnacle Harrisburg CampusHarrisburgPennsylvaniaמגייס
HCA Houston Medical CenterHoustonTexasמגייס
Huntsville HospitalHuntsvilleAlabamaמגייס
University of Kansas Medical CenterKansas CityKansasמגייס
Saint Lukes Mid America Heart InstituteKansas CityMissouriמגייס
Gundersen LutheranLa CrosseWisconsinמגייס
John L McClellan Memorial Veterans HospitalLittle RockArkansasמגייס
Medical Center of the RockiesLovelandColoradoמגייס
University of Miami HospitalMiamiFloridaמגייס
Providence Saint Patrick HospitalMissoulaMontanaמגייס
Midwest Cardiovascular InstituteNapervilleIllinoisמגייס
Vanderbilt University Medical CenterNashvilleTennesseeמגייס
TriStar Centennial Medical CenterNashvilleTennesseeמגייס
Montefiore Medical CenterNew YorkNew Yorkמגייס
Cumc/NyphNew YorkNew Yorkמגייס
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)Overland ParkKansasמגייס
The Valley HospitalParamusNew Jerseyמגייס
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvaniaמגייס
The Heart Hospital Baylor PlanoPlanoTexasמגייס
Oregon Health & Science University HospitalPortlandOregonמגייס
Rhode Island Hospital and Health Services - LifespanProvidenceRhode Islandמגייס
Saint Francis Hospital (Roslyn NY)RoslynNew Yorkמגייס
CentraCare Heart & Vascular Center MN - Saint Cloud HospitalSaint CloudMinnesotaמגייס
University of Washington (UW) Medical CenterSeattleWashingtonמגייס
Stanford Hospital & ClinicsStanfordCaliforniaמגייס
Carondelet Saint MarysTucsonArizonaמגייס
Medstar Washington Hospital CenterWashington D.C.District of Columbiaמגייס
Ascension Via Christi Saint FrancisWichitaKansasמגייס
Novant Health New Hanover Regional Medical CenterWilmingtonNorth Carolinaמגייס

אתר נוסף אחד מצוין ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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