NCT03237169

Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Centro Hospitalar Lisboa Ocidental · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.

Detailed description

Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.

Conditions

• Fractional Flow Reserve, Myocardial
• Coronary Artery Disease

Timeline

• Start date: 2016-10-28
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2017-08-02
• Last updated: 2018-05-11

Locations

6 sites across 4 countries: United States, France, Italy, Portugal