ear-infrared spectroscopy and intravascular ultrasound for risk stratification of coronary stenosis with deferred revascularization based on fractional flow reserve: The STRATIFY-NIRS study
- Conditions
- Acute coronary syndrome
- Registration Number
- JPRN-UMIN000048311
- Lead Sponsor
- Department of Cardiovascular Medicine, Shinshu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Not provided
1. Target vessels* previously treated by PCI. 2. Target vessels* with significant coronary calcification or tortuosity deemed to preclude NIRS-IVUS evaluation. 3. Target vessels* with reference lumen diameter <=2mm. 4. History of CABG. 5. Unstable clinical status (hemodynamic or electrical instability). 6. Patients unwilling or unable to provide informed consent. 7. Life expectancy is less than 1 year at study enrollment. 8. Patients considered unsuitable for the study at the discretion of the operator. *Target vessel is defined as a non-culprit coronary artery with deferred coronary lesions by FFR (i.e. FFR>0.80) with a moderate stenosis (visual estimation of diameter stenosis >=50%, <90% by coronary angiography).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target vessel failure (cardiac death, target-vessel myocardial infarction, clinically-driven target vessel revascularization) at 2 years
- Secondary Outcome Measures
Name Time Method