Status:
UNKNOWN
Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a "Work Horse" Wire
Lead Sponsor:
Central Arkansas Veterans Healthcare System
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-89 years
Brief Summary
The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with intermediate angiogra...
Detailed Description
EVALUATION OF THE OPSENS FRACTIONAL FLOW RESERVE (FFR) WIRE AS A "WORK HORSE" WIRE INVESTIGATORS: PRINCIPAL INVESTIGATOR: BARRY F URETSKY, MD CO-INVESTIGATOR: ABDUL HAKEEM, MD CO-INVESTIGATOR: MALEK...
Eligibility Criteria
Inclusion
- Patients (age 18-89 years old) eligible and in whom the operator has performed FFR will be included to systematically evaluate the performance of the OptoWire FFR wire. A total of 1000 consecutive patients deemed to require FFR as part of clinical care will be included. It is felt that 1000 patients represent a reasonable sample size to study the OptoWire FFR wire handling characteristics, the primary endpoint of the study
Exclusion
- Not a candidate for FFR
- Chronic total occlusion lesion
- Hemodynamically unstable
- Saphenous vein graft lesions -
Key Trial Info
Start Date :
April 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 10 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03227588
Start Date
April 10 2017
End Date
December 10 2019
Last Update
February 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
John L. McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States, 72205