None listed
Conditions
Interventions
Intervention1: Metalless PCI: non-surgical procedure used to treat the blockages in a coronary artery
it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart.
Intervention2: Medical Device: Participants will be randomized for medical device on the day of procedure and
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged greaterthan equal to 18 years. 2.Patients with long diffused de-novo coronary lesions greaterthan 25 mm suitable for treatment with BRS along with drug eluting balloon.3.Patient has given written informed consent for participation prior to enrolment.4.Patient is willing to undergo all study procedures and follow-up requirements.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin, ticlopidine, prasugrel, ticagrelor and drug such as Sirolimus Rapamycin or similar drugs or any analogue or derivative, poly L lactide PLLA, poly DL lactide PDLLA, platinum, or with any contrast media.2.Patient in whom antiplatelet and or anti coagulant therapy are contraindicated.3.Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon.4.Transplant patient. 5.Patients with low ejection fraction Lessthan30percentage 6.Renal insufficiency where creatinine levels are more than 1.3 mg per dl 7.Patients with vascular aneurysms 8.Lesion located in left main coronary artery 9.Aorto ostial location within 3 mm 10.Patients with Chronic Total Occlusions 11.Patients with bifurcation or trifurcation lesion disease or multivessel complex lesions 12.Patients with severely calcified vessels and angulations 13.Subject is high risk of bleeding for any reason.14.Pregnant or lactating female. 15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) [Time Frame: 1 year] Defined as the composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a non-target vessel), or ischemia-driven target lesion revascularization (ID-TLR)[1]. Timepoint: one month ,six month , one year, Two Years ,Three Years ,Four Years ,Five Years | — |
Secondary
| Measure | Time frame |
|---|---|
| .Stroke: [Time Frame: Time Frame: 1 month, 6 months, 1 year, 2years, 3 years, 4 years, 5 years][5] 8.Thrombosis [Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years] 9,Procedure success [Time Frame: Discharge] 10.Device success: [Time Frame: During procedure] 11.Length of Hospital Stay [Time Frame: at Discharge] 12,Re-hospitalizationTimepoint: one month ,six month , one year, Two Years ,Three Years ,Four Years ,Five Years | — |
Countries
India
Contacts
Public ContactYathish kumar
Meril Life Sciences Pvt Ltd
Outcome results
None listed