NCT01153555

Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy

Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy: The FIRST Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: Volcano Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective registry of patients with intermediate coronary lesions defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled into the study at sites in the United States and Europe. There will be no follow up beyond hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can predict physiological ischemia by Fractional Flow Reserve (FFR).

Detailed description

Patients undergoing cardiac catheterization must meet clinical inclusion and exclusion criteria and sign an informed consent. At the time of catheterization the patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients who fulfilled the clinical and angiographic criteria will undergo further imaging evaluation using an IVUS RF catheter (Volcano Therapeutics) and FFR wire (Radi or Volcano). The decision for treatment of any lesion will be at the operator's discretion. For patients enrolled at Washington Hospital Center and do not undergo percutaneous coronary intervention, an assessment with non invasive perfusion adenosine MRI also be performed.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-06-30
• Last updated: 2015-03-04

Locations

1 site across 1 country: United States