NCT04451044

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,212 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease
• Ischemic Heart Disease

Interventions

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

Timeline

• Start date: 2021-06-17
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2020-06-30
• Last updated: 2025-01-20

Locations

84 sites across 18 countries: United States, Australia, Austria, Canada, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study