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).

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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

تدخّليةمطلوب 1,205 مشاركين51 موقعاًدولة واحدة

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Coronary Artery Disease

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةغير منطبق
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةSINGLE (1)
التجنيدمطلوب 1,205 مشاركين

الجهة الراعية والمتعاونون

  • Medtronic Vascular الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • جهاز 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).

  • جهاز 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.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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

    الإطار الزمني 1 year post-procedure

  2. مقياس النتيجة الأولي

    DNSV Cohort Primary Analysis

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

    الإطار الزمني 1 year post-procedure

  3. مقياس النتيجة الثانوي

    Acute success

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

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  4. مقياس النتيجة الثانوي

    All deaths

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  5. مقياس النتيجة الثانوي

    Cardiac death

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  6. مقياس النتيجة الثانوي

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

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  7. مقياس النتيجة الثانوي

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

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  8. مقياس النتيجة الثانوي

    Clinically-driven target vessel revascularization (cd-TVR)

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  9. مقياس النتيجة الثانوي

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

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  10. مقياس النتيجة الثانوي

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

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  11. مقياس النتيجة الثانوي

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

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

  12. مقياس النتيجة الثانوي

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

    الإطار الزمني hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

التواريخ

تاريخ البدء24 فبراير 2025 (فعلي)
الإتمام الأولي1 فبراير 2027 (تقديري)
الإتمام1 فبراير 2031 (تقديري)
أول نشر2 أغسطس 2024 (فعلي)
آخر تحديث24 أبريل 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأبريل 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

51 موقعاً قيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Lehigh Valley Hospital - Cedar CrestAllentownPennsylvaniaقيد التجنيد
AnMed Health Medical CenterAndersonSouth Carolinaقيد التجنيد
University of Michigan Health System - University HospitalAnn ArborMichiganقيد التجنيد
Piedmont Atlanta HospitalAtlantaGeorgiaقيد التجنيد
Emory University Hospital MidtownAtlantaGeorgiaقيد التجنيد
The University of Alabama at BirminghamBirminghamAlabamaقيد التجنيد
Kaleida HealthBuffaloNew Yorkقيد التجنيد
Virtua Our Lady of Lourdes HospitalCamdenNew Jerseyقيد التجنيد
Medical University of South Carolina (MUSC)CharlestonSouth Carolinaقيد التجنيد
Advocate Illinois Masonic Medical CenterChicagoIllinoisقيد التجنيد
The Lindner Research CenterCincinnatiOhioقيد التجنيد
BayCare Health SystemClearwaterFloridaقيد التجنيد
University Hospitals Cleveland Medical CenterClevelandOhioقيد التجنيد
OhioHealth Riverside Methodist HospitalColumbusOhioقيد التجنيد
Baylor Heart & Vascular HospitalDallasTexasقيد التجنيد
Saint Elizabeth HealthcareEdgewoodKentuckyقيد التجنيد
M Health Fairview ClinicEdinaMinnesotaقيد التجنيد
Parkview HealthFort WayneIndianaقيد التجنيد
North Florida Regional Medical CenterGainesvilleFloridaقيد التجنيد
Corewell HealthGrand RapidsMichiganقيد التجنيد
The Moses H Cone Memorial HospitalGreensboroNorth Carolinaقيد التجنيد
UPMC Pinnacle Harrisburg CampusHarrisburgPennsylvaniaقيد التجنيد
HCA Houston Medical CenterHoustonTexasقيد التجنيد
Huntsville HospitalHuntsvilleAlabamaقيد التجنيد
University of Kansas Medical CenterKansas CityKansasقيد التجنيد
Saint Lukes Mid America Heart InstituteKansas CityMissouriقيد التجنيد
Gundersen LutheranLa CrosseWisconsinقيد التجنيد
John L McClellan Memorial Veterans HospitalLittle RockArkansasقيد التجنيد
Medical Center of the RockiesLovelandColoradoقيد التجنيد
University of Miami HospitalMiamiFloridaقيد التجنيد
Providence Saint Patrick HospitalMissoulaMontanaقيد التجنيد
Midwest Cardiovascular InstituteNapervilleIllinoisقيد التجنيد
Vanderbilt University Medical CenterNashvilleTennesseeقيد التجنيد
TriStar Centennial Medical CenterNashvilleTennesseeقيد التجنيد
Montefiore Medical CenterNew YorkNew Yorkقيد التجنيد
Cumc/NyphNew YorkNew Yorkقيد التجنيد
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)Overland ParkKansasقيد التجنيد
The Valley HospitalParamusNew Jerseyقيد التجنيد
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvaniaقيد التجنيد
The Heart Hospital Baylor PlanoPlanoTexasقيد التجنيد
Oregon Health & Science University HospitalPortlandOregonقيد التجنيد
Rhode Island Hospital and Health Services - LifespanProvidenceRhode Islandقيد التجنيد
Saint Francis Hospital (Roslyn NY)RoslynNew Yorkقيد التجنيد
CentraCare Heart & Vascular Center MN - Saint Cloud HospitalSaint CloudMinnesotaقيد التجنيد
University of Washington (UW) Medical CenterSeattleWashingtonقيد التجنيد
Stanford Hospital & ClinicsStanfordCaliforniaقيد التجنيد
Carondelet Saint MarysTucsonArizonaقيد التجنيد
Medstar Washington Hospital CenterWashington D.C.District of Columbiaقيد التجنيد
Ascension Via Christi Saint FrancisWichitaKansasقيد التجنيد
Novant Health New Hanover Regional Medical CenterWilmingtonNorth Carolinaقيد التجنيد

يُدرَج موقع إضافي واحد في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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