Health Condition 1: I25- Chronic ischemic heart disease Health Condition 2: I214- Non-ST elevation (NSTEMI) myocardial infarction Health Condition 3: I200- Unstable angina
Conditions
Interventions
Intervention1: Orbital Atherectomy: Orbital Atherectomy is a calcium-modifying device routinely used prior to Percutaneous Coronary Intervention (PCI) to modify calcified plaques and facilitate stent
Sponsors
Interventional Cardiology Research and Training Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, aged 18 years and above 2. Patients presenting with any one of the following conditions (a) stable ischemic heart disease, (b) acute coronary syndrome (NSTEMI or unstable angina) 3. Patients willing to sign written informed consent Imaging Inclusion Criteria 1. Use of OCT guidance is mandatory for all enrolled patients 2. Patients presenting with balloon crossable lesion 3. The target lesion(s) is a de novo coronary lesion with stenosis more than equal to 50% and less than 100%, the reference diameter of each target vessel is more than equal to 2.5 mm and less than 4.0 mm at the lesion site. 4. The target lesion has OCT evidence of severe calcium at the lesion site.
Exclusion criteria
Exclusion criteria: 1. Patients presenting with non-balloon crossable lesion 2. Patients with a history of coronary artery bypass grafting 3. Patients with hemodynamic instability or cardiogenic shock 4. Patients with chronic total occlusion and In-stent restenosis lesions 5. Patients with contraindication for dual antiplatelet therapy (DAPT) 6. Patients with recent STEMI 7. Patients unwilling to sign the informed consent Angiographic Exclusion criteria 1. The target lesion is located within a bypass graft 2. Angiographic evidence of thrombus 3. Angiographic evidence of significant dissection at the treatment site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of technical success between the two treatment armsTimepoint: Baseline (Post-Procedure) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MACE 2. Optimal Stent expansion 3. Cost Effectiveness 4. Clinical SuccessTimepoint: 1. In-hospital & 30 days 2. Post-Procedure 3. 30 days 4. Post-Procedure | — |
Countries
India
Contacts
Public ContactDr Prathap Kumar N
Meditrina Hospitals Pvt Ltd
Outcome results
None listed