Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Drug coated balloon angioplasty: Angioplasty of specified ostial coronary lesions using drug coated balloon (one time intervention followed by 6 month follow up)
Control Intervention1:
Sponsors
VMMC and Safdarjung hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stable angina with documented ischemia or typical symptoms with ECG changes or Unstable angina 2. Eligible for PCI with the intention to use balloon only strategy for de novo side branch ostial lesion (Medina classification 0,0,1) 3. Side branch with diameter greater than 2.0mm
Exclusion criteria
Exclusion criteria: 1. Left main bifurcation except isolated ostial LCX lesion. 2. If angioplasty of any other lesion is required/ performed with study procedure. 3. Severely calcified lesions 4. Contraindications to DAPT 5. History of hypersensitivity to contrast 6. Prior stenting in target vessel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic outcomes: 1. Minimum lumen diameter (MLD) 2. Percentage of diameter stenosis 3. Percentage of area stenosis 4. Acute luminal gain 5. Late lumen loss 6. Loss indexTimepoint: Procedural and 6 month follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In hospital and short term composite MACE 2. Death 3. MI: STEMI or NSTEMI 4. Revascularisation: Target lesion revascularisation, or stenting in new lesion, or coronary bypass surgery 5. Cerebrovascular accidentTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Asmita Gupta
VMMC and Safdarjung Hospital
Outcome results
None listed