Coronary Artery Disease
Conditions
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.
Interventions
None listed
Sponsors
Volcano Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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% |
| 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 |
Countries
United States
Outcome results
None listed