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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.
DEFINE GPS Substudy: Characterization of Intermediate Lesions (ChIL) will enroll approximately 350 patients at up to 20 sites. This multi-center, prospective, registry will enroll patients consented to be randomized into the DEFINE GPS study but ultimately screen fail. Baseline patient medical and demographic data will be collected along with angiographic and functional data from vessels with intermediate disease deferred from revascularization and will be used to establish a body of imaging data that can be used to validate new image-based physiology applications.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama Birmingham
Birmingham, Alabama, United States
Pima Heart & Vascular
Tucson, Arizona, United States
Central Arkansas Veterans Healthcare System (CAVHS)
Little Rock, Arkansas, United States
Glendale Adventist
Glendale, California, United States
Colorado Heart and Vascular
Lakewood, Colorado, United States
Yale University
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Memorial Healthcare
Hollywood, Florida, United States
Tampa Cardiovascular Innovations and Research
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Start Date
June 17, 2021
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2028
Last Updated
January 20, 2025
3,212
ESTIMATED participants
Philips SyncVision system with Philips pressure wires
DEVICE
standard of care angiographically-guided PCI
PROCEDURE
Lead Sponsor
Philips Clinical & Medical Affairs Global
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01311323