atherosclerosis coronary artery disease
Conditions
Interventions
Based on the average FFR and CFR measurements, PCI will be performed
immediately or deferred as follows:
• FFR >0.8 = defer
• FFR =2.0 = defer
Sponsors
University of Texas Medical School at Houston
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 3.1 Inclusion Criteria, 3.1.1 Age >= 18 years., 3.1.2 Eligible for PCI based on local practice standards during the current procedure (PCI cannot be staged)., 3.1.3 At least one epicardial stenosis of >=50% diameter (by visual or quantitative assessment) and meeting the following criteria as determined by the operator based on either a prior or the current diagnostic angiogram: • =2.5mm reference diameter (near the level of the stenosis); • and supplies sufficiently viable myocardium (exclude regions of known, prior, transmural myocardial infarction)., 3.1.4 Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: Anatomic exclusions:, 3.2.1 Prior CABG., 3.2.2 Preferred treatment strategy for revascularization would be CABG based on local practice standards., 3.2.3 Left main coronary artery disease requiring revascularization., 3.2.4 Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may also exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by ComboWire placement., 3.2.5 Known severe LV hypertrophy (septal wall thickness at echocardiography of >13 mm)., Clinical exclusions: 3.2.6 Inability to receive intravenous adenosine (for example, severe reactive airway disease, marked hypotension, or high-grade AV block without pacemaker)., 3.2.7 Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion)., 3.2.8 Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included., 3.2.9 Severe cardiomyopathy (LV ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint • 24-month rate of major adverse cardiac events: o all-cause death o documented myocardial infarction o unplanned, urgent revascularization (not cross-over revascularization) o elective revascularization (both non-urgent and repeat procedures) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints • Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina) at 6, 12, 18, and 24 months (then 5 and potentially also 10 years depending on resources) • Number of anti-anginal medications at the same time points as CCS angina class • Cerebrovascular events at any time • Bland-Altman bias, limits of agreement, and reproducibility coefficient for repeated physiology measurements • Procedure time from anticoagulation to completion of physiologic measurements • Number of tracings excluded by core physiology lab due to noise, artifact, or loss of signal | — |
Countries
Netherlands
Outcome results
None listed