A study to check the safety and effect of optical coherence tomography-guided percutaneous coronary intervention in patients with complex lesions in India

Not Applicable

• Conditions: Health Condition 1: I20-I25- Ischemic heart diseases

• Registration Number: CTRI/2019/03/018301
• Lead Sponsor: Dr Praveen Chandra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients of either sex aged 95 years > 18 years

2. Patients willing to sign the informed consent form

3. Patients scheduled for a clinically indicated PCI procedure, meeting the below criteria:

Medically treated diabetes mellitus, AND/OR

(i) Angiographically-detected high risk lesions, with at least one target lesion in the planned target vessel, and meeting the below criteria:

Target lesion is the culprit lesion responsible for either NSTEMI, or STEMI >24 hours from the onset of ischemic symptoms.

(ii)Long or multiple lesions (defined as intended total stent length in any single target vessel H28 mm)

(iii)Bifurcation lesion with side branch H2.5 mm by visual estimation, intended to be treated with planned two-stent strategy (stenting in both the main branch and side branch)

(iv) Angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion)

(v)In-stent restenosis (all patterns, as long as the lesion is at or within the stent margin(s) and has an angiographically visually-assessed DS H70% or DS H50% with non-invasive or invasive evidence of ischemia)

Exclusion Criteria

1.Patients unwilling to sign informed consent

2.Patients with bypass graft stenoses

3.Patients with renal insufficiency (estimated glomerular filtration rate <50 mL/min/m2) or any other severe medical condition interfering with patientsâ?? safety or study results

4. Patients with contraindications to dual-antiplatelet therapy up to 1 year

5.Patients with other comorbidities that may limit life expectancy to less than one year

Study & Design

• Study Type: Observational
• Study Design: Not specified