Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Mural DEB and Mural DES: PCI using Mural Drug-Eluting Balloon (DEB) and/or Mural Drug-Eluting Stent (DES) based on lesion characteristics and operator discretion.
Intervention2: Drug Co
Sponsors
Dr Stigi Joseph
Eligibility
Inclusion criteria
Inclusion criteria: The patient must be 18 years of age or older. True coronary bifurcation with fifty percent or more diameter stenosis in both the main and side branches, belonging to the Medina classifications 1 1 1, 1 0 1, or 0 1 1. Patients with bifurcation lesions in native coronary arteries with a reference vessel diameter of two point five millimeters or more for both the main vessel and side branch by visual estimation. The patient must agree not to participate in any other clinical trial for a period of two years following the index procedure. The patient is willing to comply with protocol-specified follow-up evaluations. The patient or his or her legally authorized representative, if applicable, agrees to provide written informed consent as approved by the respective Ethics Committee and applicable regulatory authorities.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media. 2. Patients in whom anti-platelet and/or anti-coagulant therapy are contraindicated. 3. Pregnant or nursing patients or those who plan pregnancy during study period 4. Any condition, which in the Investigator s opinion would preclude safe participation of patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure Defined as the composite of cardiac death, target lesion related MI (TL-MI), and clinically driven target lesion revascularization (CD-TLR)Timepoint: 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE)Timepoint: 30 days, 6 months, 1 year.;Cardiac DeathTimepoint: 30 days, 6 months, 1 year;Target vessel and Target bifurcation-related MI (TV-MI)Timepoint: 30 days, 6 months, 1 year;Clinically Driven Target Lesion Revascularization (CD-TLR)Timepoint: Time Frame: 30 days, 6 months, 1 year;Target Vessel Failure (TVF):Timepoint: 30 days, 6 months, 1 year;Target Vessel Revascularization (TVR)Timepoint: 30 days, 6 months, 1 year;Stent thrombosis (Probable/definite)Timepoint: 30 days, 6 months, 1 year;StrokeTimepoint: 30 days, 6 months, 1 year;BleedingTimepoint: At the time of index procedure, 30 days;Target bifurcation revascularizationTimepoint: Time Frame: 30 days, 6 months, 1 year;Device successTimepoint: Post-procedure;Procedure successTimepoint: Discharge;Procedure timeTimepoint: At the time of index procedure;Side branch (SB) Occlusion:Timepoint: Post-procedure;Main branch (MB) Occlusion:Timepoint: Post-procedure;Fluoro TimeTimepoint: At the time of index procedure;Quality of lifeTimepoint: Baseline, 30 days, 1 year;Quantum of contrast agent or dye usedTimepoint: At the time of index procedure | — |
Countries
India
Contacts
Public ContactDr Stigi Joseph
Little Flower Hospital and Research Centre
Outcome results
None listed