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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.

A Prospective, Multicentric, Non-Interventional Data Collection Registry to report the safety & feasibility of 3D OCT-Guided Distal Left Main Bifurcation Percutaneous Coronary Intervention with Everolimus-Eluting Stents in South Asian setting

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/034819
Enrollment
100
Registered
2021-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

None listed

Sponsors

Meditrina Hospitals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Procedural success (residual angiographic stenosis 30% + TIMI 3 flow in all branches + adequate OCT stent expansionTimepoint: Baseline

Secondary

MeasureTime frame
1. Rate of major adverse cardiac events (MACE) 2. Percentage of patients with change in PCI strategy based on ACR 3. Change in contrast volume 1-50 and 51-100 patients Timepoint: 7 days & 12 months In-Hospital In-hospital

Countries

India, Maldives

Contacts

Public ContactDr Prathap Kumar N

Meditrina Hospitals Pvt. Ltd

prathapndr@gmail.com9447082430

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026