Health Condition 1: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarction
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants aged Above or older to 18 years irrespective of gender with cardiovascular stenosis who will undergo an endovascular procedure require vessel dilatation. 2. Participants who require dilatation of stenotic portions also including total occlusionsand AMI participants. 3.The participants who require dilatation of native coronary arteries for plaque modification. 4. The Participant is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form in the presence of an impartial witness. 5. Participant is willing and able to comply with post-operative scheduled clinical evaluations
Exclusion criteria
Exclusion criteria: 1.Participants with hypersensitivity or allergies to aspirin heparin clopidogrel ticlopidine bivalidurin prasugrel ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil polyvinyl pyrollidone vitamin E TPGS , Pluronic F 68 or any contrast media. 2. Participants in whom anti-platelet and or anti-coagulant therapy are contraindicated. 3. Pregnant or lactating females. 4. Participants judged to have a lesion that prevents complete inflation of an angioplasty balloon. 5.Transplant Participants. 6. Participants with calcified lesions requiring another type of treatment, such as Rotational Atherectomy. 7. Participants with unprotected left main coronary artery lesions. 8. The Participants with Coronary artery spasm in the absence of a significant stenosis. 9. Participants whose diseased segment cannot be pre-dilated or prepared before drug-coated balloon treatment. 10. Participants with unresolved vessel thrombus at the lesion site. 11.Participants with unprotected lesions located in the left main coronary artery. 12. Participants under high risk of primary Percutaneous Coronary Intervention (PCI) for acute myocardial infarction characterized by presence of cardiogenic shock or evidence of massive thrombus in the infarct-related artery. 13.The participant who is unwilling or unable to sign the Informed Consent Document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Procedure Success 2.Major Adverse Cardiac EventsTimepoint: 1. Intraoperative 2.Through discharge, 1 week 2 days, 1 month 7 days, 3 months 15 days, 6 months 30 days, 1 year 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device Success 2. Change in Late Lumne Loss 3. Target Vessel Revascularization 4. Product Performance 5. Adverse Events 6. Laboratory Measurements & Non-Invasive TestsTimepoint: Baseline , Through Discharge , 1 week , 1 month, 6 months, 1 year | — |
Countries
India
Contacts
Public ContactDrKiranKumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed