Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Translumina Therapeutics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age above 18 years 2. Patients with symptomatic coronary artery disease (including those with acute coronary syndromes (except Acute STEMI) or Chronic Coronary Syndromes) with either symptoms and/or ischemia. 3. The patient must be able to understand and provide informed consent and comply with all study procedures. Angiographic inclusion criteria 1. Greater than or equal to 70% target lesion stenosis in LAD, LCX, or RCA (or branches) which after successful pre-dilatation has a residual stenosis, less than or equal to 30% and no dissection greater than Type C (NHLBI guidelines) (pre-dilatation permitted with SC or NC balloon catheter, cutting/scoring balloon, rotational/orbital atherectomy, IVL or laser) 2. The target vessel reference diameter must be between 2.0 and 4.5 mm.
Exclusion criteria
Exclusion criteria: 1. LVEF less than or equal to 30% 2. Known contraindication or hypersensitivity to paclitaxel, and/or to any anti-thrombotic and anti-platelet class of drugs. 3. Allergy to imaging contrast media which cannot be adequately pre-medicated. 4. Patient undergoing planned surgery within 3 months with the necessity to stop DAPT. 5. Patient is pregnant or nursing lactating women. 6. Patient is recipients of a heart transplant. 7. Patient is unwilling or unable to give follow-up till study completion. 8. Currently participating in another trial. 9. Life Expectancy less than 1 year. Angiographic exclusion criteria: 1. Target lesion is in the left main coronary artery. 2. Flow limiting target vessel thrombus. 3. Vessel dissection requiring bailout stenting (in the case of bailout stenting only follow-up will be excluded. We wonâ??t follow up the patient with bailout stenting, but the baseline and procedural data will be collected for the patient as that will provide us the frequency of vessel injury during the DCB/DEB angioplasty procedure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is TLF rate through 12 months. (The primary endpoint of the study is a composite endpoint. Cumulative TLF is defined as events of Cardiac Deaths, Target vessel-related Myocardial Infarction, and clinically driven Target Lesion Revascularization at 12 months after the index procedure.) Timepoint: 12 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device success - Defined as the ability of the study device to be delivered, dilated and retrieved from the target lesion. 2. Procedural success Defined as technical and angiographic success in the absence of major adverse events during hospitalization. 3. Patient Oriented Composite Endpoints (PoCE)- Composite of all cause death, any MI, or any revascularization. Timepoint: 6 month and 12 month | — |
Countries
India
Contacts
Public ContactDr Brijesh Mishra
Translumina Therapeutic Pvt Ltd
Outcome results
None listed