Status:
COMPLETED
Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy
Lead Sponsor:
Volcano Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Brief 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 a...
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 e...
Eligibility Criteria
Inclusion
- Sign written informed consent to participate in the study.
- Clinical indication for coronary angiography for stable or unstable angina
- Specific Angiographic
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01153555
Start Date
September 1 2010
End Date
June 1 2012
Last Update
March 4 2015
Active Locations (1)
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1
Washingtoon Hospital Center
Washington D.C., District of Columbia, United States, 20010