Health Condition 1: I20-I25- Ischemic heart diseases
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Sironity Sirolimus Drug Coated PTCA Balloon Catheter: The Sironity DCB is a rapid-exchange angioplasty balloon catheter with a non-compli
Sponsors
Sahajanand Medical Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient must meet all the following criteria to be eligible for treatment in the study: 1. Adults (more than or equal to 18 years old) with either ISR or de novo lesions in small coronary vessels (reference vessel diameter less than equal to 2.75 mm). 2. Target lesions are considered to require intervention and are suitable for treatment with balloon-based therapy using the Sironity DCB. 3. Multiple target lesions may be treated provided that each lesion is either located in a different target vessel or, if within the same target vessel, is clearly separated by an adequate segment of normal vessel and treated with a separate Sironity DCB. The use of any drug-eluting stent or any drug-coated balloon other than the Sironity DCB in the same target vessel is not permitted. 4. Patients with documented angina and/or positive functional ischemia testing,or presenting with unstable angina, or stabilized non ST-elevation myocardial infarction (NSTEMI). 5. Patients with prior ST-elevation myocardial infarction (STEMI) are eligible if the index procedure is performed more than or equal to 14 days post-STEMI and the patient is clinically stable. 6. Lesion length less than or equal to 36 mm. 7. Target vessel diameter within the range specified in the Sironity DCB Instructions for Use (IFU). 8. Able to provide informed consent and comply with the follow-up schedule.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if any of the following criteria are met: 1. Severely calcified lesions or lesions that are heavily thrombotic and not amenable to balloon-based therapy. 2. Lesions requiring complex interventions (e.g., bifurcations requiring two-stent techniques or tortuous anatomy). 3. Known hypersensitivity to sirolimus or any of the components of the Sironity DCB. 4. Patients presenting with ST-elevation myocardial infarction (STEMI). 5. Patients presenting with non ST-elevation myocardial infarction (NSTEMI) with ongoing chest pain or hemodynamic instability. 6. Patients presenting with Killip class III (pulmonary edema) or class IV (cardiogenic shock). 7. Patients with chronic heart failure classified as NYHA class III or IV prior to the index PCI. 8. Severe left ventricular dysfunction (ejection fraction [EF] less than 30%). 9. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30mL/min/1.73m ) . 10.Life expectancy less than 1 year due to comorbid conditions unrelated to coronary artery disease. 11.Lesions located in vein grafts, coronary artery bypass grafts, or the left main coronary artery. 12.Target lesion represents a chronic total occlusion (CTO). 13.Active bleeding disorders or patients with uncontrolled anticoagulation. 14.Pregnancy or breastfeeding (due to the potential risks associated with sirolimus). 15.Severe systemic illness or other conditions that, in the opinion of the investigator, would interfere with the patients ability to complete the study follow-up. 16. Patients currently enrolled in another investigational drug or device study that has not yet completed primary endpoint follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF), which is defined as a composite of cardiac death (CD), target-vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR)Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute success (device, and procedure) Timepoint: Through hospital discharge only ;All deaths Timepoint: Hospital discharge, 30 days, 6 and 12 months ;Cardiac death Timepoint: Hospital discharge, 30 days, 6 and 12 months;All myocardial infarction (MI), including TV-MI Timepoint: Hospital discharge, 30 days, 6 and 12 months;CD-TLR defined as repeat PCI or CABG to the target lesion Timepoint: Hospital discharge, 30 days, 6 and 12 months;Clinically-driven target vessel revascularization (CD-TVR) defined as repeat PCI or CABG to the target vessel Timepoint: Hospital discharge, 30 days, 6 and 12 months;Major adverse cardiac event (MACE) defined as composite of all-cause mortality,any MI, any stroke, hospitalization for heart failure, or any revascularizationTimepoint: Hospital discharge, 30 days, 6 and 12 months;TLF defined as composite of cardiac death, TV-MI, or CD-TLRTimepoint: Hospital discharge, 30 days, and 6 months ;Target vessel failure (TVF) defined as composite of cardiac death, TV-MI, or CDTVR Timepoint: Hospital discharge, 30 days, 6 and 12 months;Target lesion thrombosis (TLT) (definite or probable)Timepoint: Hospital discharge, 30 days, 6 and 12 months;BARC 3 5Timepoint: Hospital discharge, 30 days, 6 and 12 months;Any strokeTimepoint: Hospital discharge, 30 days, 6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Ashok Seth
Fortis Escorts Heart Institute
Outcome results
None listed