Status:
COMPLETED
FUnctional diagnoSIs of corONary Stenosis (FUSION)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Coronary Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
Detailed Description
This study is a single-arm, prospective, multi-center study collecting OCT pullback images of lesions pre-percutaneous coronary intervention (PCI) and (optional) post-PCI procedure, and the correspond...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Patient provides written informed consent
- Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic assessment to guide physician clinical course (in lesions with visual % diameter stenosis 40-90%), if clinically indicated
- Subject is undergoing invasive FFR with Adenosine (high-dose intra-coronary (IC) \[200 μg for the left and or 100 μg for the right coronary artery\] or 140 μg/kg/min for intravenous (IV)) used as hyperemic stimulus
- Clinical presentation with or history of stable angina, unstable angina, or silent ischemia (defined as abnormal stress test or abnormal invasive physiology assessment) that has led to the procedure
- General
Exclusion
- Prior history of myocardial infarction (MI) in the target vessel
- Presence of acute ST Elevation Myocardial Infarction (STEMI)
- Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
- TIMI flow \< Grade 3 at baseline or visible thrombus
- Prior history of coronary artery bypass grafting (CABG)
- Prior heart transplant
- Severe valvular heart disease or history of valve repair or replacement
- Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis.
- Target coronary vessel is supplied by major collaterals or is supplying major collaterals to a CTO (chronic total occlusion)
- CTO in the target vessel
- Severe diffuse disease observed in target vessel defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree
- Presence of myocardial bridge (MB), regardless of vessel location
- Contraindication for FFR examination or administration of vasodilators
- Known LVEF ≤45%
- Target lesion involves Left Main coronary artery or ostial right coronary artery
- Known renal insufficiency (eGFR \< 30 ml/kg/m\^2 or serum creatinine ≥ 2.5 mg/dL) unless patient is on dialysis
- Heart Failure NYHA Class III or IV
- Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (≤14 days) prior to the index procedure per site standard test)
- Subject has or had active COVID-19 symptoms and/or a positive test result within the prior 2 months
- Participation in another clinical study of an investigational drug or device
- Presence of aneurysm in the target vessel
- Imaging and Pressure Tracing
Key Trial Info
Start Date :
June 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT04356027
Start Date
June 26 2020
End Date
October 15 2021
Last Update
February 21 2025
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Heart Center Research, LLC.
Huntsville, Alabama, United States, 35801
2
HonorHealth
Scottsdale, Arizona, United States, 85258
3
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
4
VA Palo Alto Medical Center
Palo Alto, California, United States, 94604