A prospective, single-centre study to investigate the role of Optical Coherence Tomography and fractional flow reserve for post coronary angioplasty stent optimisatio
- Conditions
- Health Condition 1: I208- Other forms of angina pectoris
- Registration Number
- CTRI/2021/04/032543
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients >= 18 and <= 75 years of age and undergoing PCI of native coronary arteries for stable ischemic heart disease
At least >=1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between >= 50 % and < 90%, and FFR <0.8 will be included
Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect
Patients with USA/NSTEMI or ST elevation myocardial infarction
Clinical instability with compromised hemodynamics
Patients with a medical condition that limits the life expectancy to less than one year
Patients scheduled to undergo surgery within 3 months that requires interruption of DAPT
Women who are pregnant or planning to be pregnant
Patients with allergy to contrast agents
Patients with coronary artery bypass graft
Patients with a history of adverse reactions to aspirin, clopidogrel, or prasugrel
Patients in whom optimum OCT image acquisition is not feasible
Patients with chronic renal failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of OCT stent Optimization parameters with post PCI FFR (primary)Timepoint: immediately after the procedure
- Secondary Outcome Measures
Name Time Method MACE (cardiovascular death, non-fatal myocardial infarction or target vessel <br/ ><br>revascularization, CVA) at 6 months follow up (secondary)Timepoint: 6 months