FUnctional diagnoSIs of corONary Stenosis (FUSION)

Abbott

Status

Completed

Conditions

Coronary Artery Disease

Coronary Stenosis

Treatments

Other: VFR Analysis

Procedure: ICA (Invasive Coronary Angiography)

Procedure: OCT

Procedure: FFR

Study type

Observational

Funder types

Industry

Identifiers

NCT04356027

ABT-CIP-10331

Details and patient eligibility

About

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).

Full 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 corresponding pressure tracings and physiology indices. Up to 30 centers in the US will enroll approximately 310 patients. The expected duration of enrollment is approximately 15 months. The total duration of the clinical investigation is expected to be approximately 27 months.

Enrollment

312 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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 Criteria:

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 Exclusion Criteria:

Artifact in pre-PCI OCT for the target lesion or in the event of multiple target lesions, artifact in pre-PCI OCT for ALL target lesions
Target lesion requires any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement, or in case of multiple target lesions, ALL target lesions require-any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement
Severe vessel tortuosity or calcification in the target vessel such that it is unlikely that the OCT catheter can be delivered
Target lesion not imaged by OCT or in the event of multiple target lesions, ALL target lesions not imaged by OCT
Pressure drift of > 0.03; i.e. Pd and Pa ratio value < 0.97 or > 1.03, unless physiology measurements are repeated after re-equalization
Target lesion or significant CAD beyond 60mm from coronary ostium; i.e. not able to clearly image and capture all disease segment with OCT in 1 run
Incorrectly done or unsuccessful catheter purge and/or contrast flush
Presence of plaque rupture and/or intravascular hematoma in target vessel (visual % diameter stenosis ≥ 40%)
Inability to receive intracoronary nitroglycerin prior to OCT or FFR
Use of flush media other than radiographic contrast