CTRI/2026/04/107710尚未招募Unknown
A Post-Market Clinical Follow-up Study of the Sironity Sirolimus-Coated Balloon in Patients With In-Stent Restenosis or De Novo Small Vessel Coronary Lesions:Sironity PMCF Study – INDIA
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 3
研究概览
简要总结
This is a prospective, multicenter, observational PMCF study aims to evaluate the clinical safety and performance of the Sironity Sirolimus Coated PTCA Balloon Catheter in real world Indian patients undergoing PCI for either in stent restenosis (ISR) or de novo small vessel coronary lesions (reference vessel diameter less than or equal to 2.75 mm). A total of 164 patients (60 ISR and 104 de novo small vessel disease) will be enrolled, with standard of care treatment and follow up at 30 days, 6 months, and 12 months. Additionally, first 30 consecutive eligible patients (15 with in-stent restenosis [ISR] and 15 with de novo small-vessel disease [DNSV]) will undergo detailed quantitative coronary angiography (QCA) at baseline and 6 months. The primary endpoint is 12 month target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient must meet all the following criteria to be eligible for treatment in the study:
- •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).
- •Target lesions are considered to require intervention and are suitable for treatment with balloon-based therapy using the Sironity DCB.
- •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.
- •Patients with documented angina and/or positive functional ischemia testing,or presenting with unstable angina, or stabilized non–ST-elevation myocardial infarction (NSTEMI).
- •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.
- •Lesion length less than or equal to 36 mm.
- •Target vessel diameter within the range specified in the Sironity DCB Instructions for Use (IFU).
- •Able to provide informed consent and comply with the follow-up schedule.
排除标准
- •Patients will be excluded from the study if any of the following criteria are met:
- •Severely calcified lesions or lesions that are heavily thrombotic and not amenable to balloon-based therapy.
- •Lesions requiring complex interventions (e.g., bifurcations requiring two-stent techniques or tortuous anatomy).
- •Known hypersensitivity to sirolimus or any of the components of the Sironity DCB.
- •Patients presenting with ST-elevation myocardial infarction (STEMI).
- •Patients presenting with non–ST-elevation myocardial infarction (NSTEMI) with ongoing chest pain or hemodynamic instability.
- •Patients presenting with Killip class III (pulmonary edema) or class IV (cardiogenic shock).
- •Patients with chronic heart failure classified as NYHA class III or IV prior to the index PCI.
- •Severe left ventricular dysfunction (ejection fraction [EF] less than 30%).
- •Severe renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30mL/min/1.73m²) .
- •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.
- •Patients currently enrolled in another investigational drug or device study that has not yet completed primary endpoint follow-up.
研究者
Dr Ashok Seth
Fortis Escorts Heart Institute
研究点 (3)
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