Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting (DEFINE GPS)
Sponsor: |
Philips Clinical & Medical Affairs Global |
Enrolling: |
Male and Female Patients |
Clinic Visits: |
3 |
IRB Number: |
AAAT5107 |
U.S. Govt. ID: |
NCT04451044 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI strategy; To establish the relationship between physiological guidance and improvement in associated angina and quality of life scores; To examine the outcomes in patients in whom an optimized post-PCI iFR can versus cannot be achieved.
Investigator
Megha Prasad
Are you 18 years of age or older? |
Yes |
No |
Have you ever had coronary artery bypass surgery? |
Yes |
No |
Have you had a heart transplant? |
Yes |
No |
Are you pregnant? |
Yes |
No |
Have you had active COVID-19 symptoms and/or a positive test result within the prior 2 months? |
Yes |
No |