Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy

Completed

Conditions studied: Coronary Artery Disease

In brief

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).

Key facts

Study ID

NCT01153555

Run by

Volcano Corporation

People needed

350

Starts

2010-09-01

Expected to finish

2012-06-01

Last updated by the study team

2015-03-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign written informed consent to participate in the study.
• Clinical indication for coronary angiography for stable or unstable angina
• Specific Angiographic Inclusion Criteria:
• Patients required to have an intermediate coronary lesion (stenosis 40-80% by visual estimate) in one or more native, major epicardial coronary artery with reference diameter ≥2.5mm (visual estimate)
• The vessel(s) with the intermediate lesion must have no flow limiting lesions and must be available for imaging and must be considered safe for imaging evaluation.

You may not qualify if…

• Patient has had a documented acute ST-segment elevation myocardial infarction within the past 24 hours
• Decompensated heart failure or hypotension requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.
• Renal dysfunction (creatinine clearance < 60 mL/min/1.73m2)
• Pregnancy or breast-feeding
• Standard contra-indications to MRI for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (AICD), and aneurysm clips
• Body weight > 400lbs
• Left ventricular hypertrophy >1.5cm by by echocardiogram
• History of bronchospasm or asthma
• ECG evidence of conduction defect, including 2nd or 3rd degree AVB
• Patient has a known hypersensitivity, allergy or contraindication to gadolinium-based contrast agents.
• Prior participation in this study or patient is currently enrolled in another investigational use device or drug study that has not reached its primary endpoint. If the patient is enrolled in another study that is not investigational, required visits for that trial must not interfere with the conduct of this trial.
• Angiographic Exclusion Criteria:
• Unprotected left main lesion location.
• Ostial lesion
• Angiographic evidence of severe calcification or marked tortuosity of the target vessel that would preclude safe imaging
• Lesion is located within or distal to an arterial or saphenous vein graft.
• Angiographic presence of thrombus in the lesion or vessel studied.
• Lesion in a vessel with <2.5 mm reference diameter or with more than one lesion in the vessel

Where it is running

• Washingtoon Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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