Health Condition 1: I248- Other forms of acute ischemic heart disease
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Symbiosis Speciality Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged =18 years Patients with coronary artery lesions (de-novo, In-stent restenosis and high-bleeding risk [HBR])) eligible for treatment using Mozec SEB as per investigator’s discretion. Patient has given written informed consent for participation prior to enrolment Patient is willing to undergo all study procedures and follow-up requirements.
Exclusion criteria
Exclusion criteria: Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin, ticlopidine, prasugrel, ticagrelor and drug such as Sirolimus or with any contrast media.Patient in whom anti-platelet and/or anti-coagulant therapy are contraindicated.Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon. Transplant patient.Patients with low ejection fraction. Patients with vascular aneurysms.Lesion located in left main coronary artery. Aorto-ostial location (within 3 mm). Patients with chronic total occlusions. Patients with severely calcified vessels and angulations. Pregnant or lactating female. Any condition, which in the treating surgeon’s opinion would preclude safe participation of patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiovascular Events (MACE) [Time Frame: 12 months] Defined as the composite of cardiac death, target vessel Myocardial infarction (TV-MI), and target lesion revascularization (TLR).Timepoint: Time Frame: 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular deathTimepoint: Time Frame: 1 month, 6 months, 12 months;Target Vessel Myocardial InfarctionTimepoint: Time Frame: 1 month, 6 months, 12 months;Target Vessel Revascularization (TVR)Timepoint: Time Frame: 1 month, 6 months, 12 months;Target Lesion Revascularization (TLR)Timepoint: [Time Frame: 1 month, 6 months, 12 months;RestenosisTimepoint: Time Frame: 12 months;Quality of Life (QoL)Timepoint: Time Frame: Baseline, 1 month, 6 months, 12 months;Procedure successTimepoint: Time Frame: Discharge;Device successTimepoint: Time Frame: During procedure;Length of Hospital StayTimepoint: Time Frame: at Discharge | — |
Countries
India
Contacts
Public ContactDr Ankur Phatarpekar
Symbiosis Speciality Hospital
Outcome results
None listed