Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01153555
• Lead Sponsor: Volcano Corporation

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 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.

Study Timeline

• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Study Start: 2010-09
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-27
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between (Minimum Luminal Area) MLA and FFR	Day of Procedure	The correlation between MLA and FFR; and the threshold value for MLA corresponding to an FFR \< 0.8.

Secondary Outcome Measures

Name	Time	Method
Correlation between FFR and IVUS and VH parameters	Day of Procedure	Correlation between FFR and various IVUS measurements (MLA,area stenosis, lesion length, plaque burden) and VH parameters (plaque type and presence of a TCFA)
Identify risk score model	1 year	To identify a risk score model taking into account IVUS measurements (MLA, plaque burden, area stenosis, lesion length) and VH parameters (plaque type and presence of TCFA) associated with FFR \< 0.8
Association of FFR and Cut-off of MLA	Day of Procedure	Assess the association between FFR \<0.75 and 0.8 and determined cut-off of MLA with presence of a Thin Cap Fibro-Atheroma(TCFA) and/or plaque burden ≥70%

Trial Locations

Locations (1)

Washingtoon Hospital Center; 🇺🇸 Washington, District of Columbia, United States