Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT04451044
Status
Enrolling By Invitation

Conditions

  • Coronary Artery Disease
  • Ischemic Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Philips SyncVision system with Philips pressure wires — DEVICE
    Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
  • standard of care angiographically-guided PCI — PROCEDURE
    Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy

Study Details

Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

Key Dates

Start date
Jun 17, 2021
Status verified
Jan 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
3,212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: physiologically-guided arm
    Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
  • Active Comparator: angiographically-guided arm
    Standard of care angiographically-guided PCI for determining the PCI strategy

Primary Outcome Measure

Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years [ Time Frame: 2 years ]

Locations (40)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35294-
Pima Heart & VascularTucsonArizona85716-
Central Arkansas Veterans Healthcare System (CAVHS)Little RockArkansas72205-
Glendale AdventistGlendaleCalifornia91206-
Colorado Heart and VascularLakewoodColorado80228-
Yale UniversityNew HavenConnecticut06520-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Memorial HealthcareHollywoodFlorida33201-
Tampa Cardiovascular Innovations and ResearchTampaFlorida33607-
Emory University HospitalAtlantaGeorgia30322-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Straub Medical CenterHonoluluHawaii96813-
Carle Foundation HospitalUrbanaIllinois61801-
Community Healthcare SystemMunsterIndiana46321-
University of Kansas Medical CenterKansas CityKansas66160-
Brigham and Women's HospitalBostonMassachusetts02115-
Mass GeneralBostonMassachusetts02114-
Metro Cardiology ConsultantsCoon RapidsMinnesota55433-
Fairview Health ServicesEdinaMinnesota55435-
Washington University School of MedicineSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Gates Vascular InstituteBuffaloNew York14203-
Northwell HealthLake SuccessNew York11042-
Columbia University Medical CenterNew YorkNew York10032-
St. Francis HospitalRoslynNew York11576-
NC Heart and Vascular Research, LLCRaleighNorth Carolina27607-
Summa Health SystemAkronOhio44304-
Cleveland ClinicClevelandOhio44195-
Bryn Mawr HospitalBryn MawrPennsylvania19010-
Jefferson Einstein Medical CenterPhiladelphiaPennsylvania19141-
UPMC PresbyterianPittsburghPennsylvania15213-
Lankenau Medical CenterWynnewoodPennsylvania19096-
North Central HeartSioux FallsSouth Dakota57108-
Ascension Saint ThomasNashvilleTennessee37205-
Centennial Medical CenterNashvilleTennessee37203-
Baylor Scott & White, The Heart Hospital PlanoPlanoTexas75093-
Sentara HealthNorfolkVirginia23502-
Carilion ClinicRoanokeVirginia24014-
Gundersen HealthLa CrosseWisconsin54601-

Find similar trials in Birmingham, AL

By research site
University of Alabama Birmingham· Birmingham, ALPima Heart & Vascular· Tucson, AZCentral Arkansas Veterans Healthcare System (CAVHS)· Little Rock, ARGlendale Adventist· Glendale, CAColorado Heart and Vascular· Lakewood, COYale University· New Haven, CT

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