Health Condition 1: I220- Subsequent ST elevation (STEMI) myocardial infarction of anterior wall
Conditions
Interventions
Intervention1: Cutting Balloon: Percutaneous Coronary Intervention in Coronary Artery Disease-In Stent Restenosis patients.
Enrolment period is 10 months and 1 month follow up.
Intervention2: High Pre
Sponsors
SIS Medical AG
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting with in-stent restenosis (ISR) in coronary arteries requiring revascularization for percutaneous coronary intervention (PCI).Patients or a legally authorized representative must provide written informed consent to participate in the study.Patients with angiographically confirmed ISR in a previously implanted coronary stent, Suitable for OCT imaging
Exclusion criteria
Exclusion criteria: Severe left ventricular dysfunction (ejection fraction less than 30%). History of a stroke or transient ischemic attack (TIA) within 7 days, or any prior intracranial haemorrhage. Anatomy where the device or OCT catheter are unlikely to be delivered due to tortuosity like CTO lesions. Concurrent participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent expansion ratio as assessed by OCT at the end of the procedure. Stent expansion will be calculated as the minimal stent area (MSA) achieved post-treatment, compared to the reference vessel diameter.Timepoint: At Baseline, 1 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural Success. Procedural Complications. MACE Extra Modality Procedural Duration Timepoint: At baseline during the index procedure | — |
Countries
India
Contacts
Public ContactDr Praveen Chandra
Medanta- The Medicity
Outcome results
None listed