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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,212
Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy
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
Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina
Time frame: 30 days, 1 year
All-cause, cardiac and non-cardiac mortality
Time frame: 30 days, 1 year and 2 years
All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI
Time frame: 30 days, 1 year and 2 years
Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR
Time frame: 30 days, 1 year and 2 years
Hospitalization for progressive or unstable ischemia
Time frame: 30 days, 1 year and 2 years
Stent thrombosis (definite, probable and definite/probable)
Time frame: 30 days, 1 year and 2 years
Angina-related Quality of Life
Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score
Time frame: 30 days, 1 year and 2 years
Resource utilization
The \[US-based\] cost of all health care resources associated with the index procedure and pre-specified event costs throughout the two-year follow up period
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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
...and 74 more locations
Time frame: 30 days, 1 year and 2 years
Cost effectiveness
Cost per quality-adjusted life years gained
Time frame: 30 days, 1 year and 2 years