Health Condition 1: I20-I25- Ischemic heart diseases
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr Praveen Chandra
Eligibility
Inclusion criteria
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
Exclusion criteria: 1.Patients unwilling to sign informed consent 2.Patients with bypass graft stenoses 3.Patients with renal insufficiency (estimated glomerular filtration rate 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the minimum stent area 2.To assess the incidence of acute kidney injuryTimepoint: 1.Day 1 2.Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the â?? (1) effectiveness of OCT in detecting edge dissections and (2) the number of treated edge dissections Timepoint: Day 1;To assess the luminal gain and stent expansionTimepoint: Day 1;To assess the rate of major adverse cardiac events (MACE), cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR) Timepoint: 1, 6 and 12 months;To evaluate the economic considerations of using the OCT technologyTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed