Real World, Data Collection Registry to report the safety & feasibility of 3D OCT-Guided Distal Left Main Bifurcation Percutaneous Coronary Intervention with Everolimus-Eluting Stents.
Not Applicable
- Conditions
- Health Condition 1: I259- Chronic ischemic heart disease, unspecified
- Registration Number
- CTRI/2021/07/034819
- Lead Sponsor
- Meditrina Hospitals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients of either gender, aged between 20 and 80 years with a diagnosis of stable ischemic heart disease (SIHD) or acute coronary syndrome (ACS)
2. PCI with single or multiple EES for the treatment of lesion located at left main coronary artery (LMCA) bifurcation and defined as a diameter stenosis >= 50% by visual estimation
3. Lesions suitable to be treated with OCT guided Distal LM PCI
4. Patients willing to sign the informed consent form
Exclusion Criteria
1. Patients unwilling to sign the informed consent
2. ST-elevation myocardial infarction (STEMI)
3. Hemodynamic instability (cardiogenic shock)
4. Patients who have a life expectancy of less than 12 months
5. Contraindication for dual antiplatelet therapy (DAPT)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural success (residual angiographic stenosis 30% + TIMI 3 flow in all branches + adequate OCT stent expansionTimepoint: Baseline
- Secondary Outcome Measures
Name Time Method 1. Rate of major adverse cardiac events (MACE) <br/ ><br>2. Percentage of patients with change in PCI strategy based on ACR <br/ ><br>3. Change in contrast volume 1-50 and 51-100 patients <br/ ><br>Timepoint: 7 days & 12 months <br/ ><br>In-Hospital <br/ ><br>In-hospital