A prospective, single-centre, single-arm registry to evaluate short and mid-term experience of Mozecâ„¢ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter in patients with coronary artery disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events (MACE) [Time Frame: 12 months]
研究概览
简要总结
Percutaneous coronary intervention (PCI) often with the implantation of a stent is considered standard revascularization treatment of flow-limiting coronary stenosis. The first introduced stent was a bare metal stent (BMS) to reduce restenosis of the treated segment by balloon angioplasty. However, restenosis from neointimal hyperplasia in the stented area, known as in-stent restenosis, remained a complication of BMS[17] . By combining the mechanical balloon dilatation of the vessel with local delivery of antiproliferative medicine, introduction of the drug-eluting stent (DES) reduced the incidence of instent restenosis. However, DESs imply other limitations, including increased bleeding risks associated with the need for prolonged dual antiplatelet therapy (DAPT) and the risk of late and very late stent thrombosis (ST)[9,10] . Therefore, current study aims to collect real-world data of Mozecâ„¢ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter in patients with coronary artery disease.
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
- •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.
排除标准
- •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.
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE) [Time Frame: 12 months]
时间窗: Time Frame: 12 month
Defined as the composite of cardiac death, target vessel Myocardial infarction (TV-MI), and target lesion revascularization (TLR).
时间窗: Time Frame: 12 month
次要结局
- Cardiovascular death(Time Frame: 1 month, 6 months, 12 months)
- Target Vessel Myocardial Infarction(Time Frame: 1 month, 6 months, 12)
- Target Vessel Revascularization (TVR)(Time Frame: 1 month, 6 months, 12)
- Target Lesion Revascularization (TLR)([Time Frame: 1 month, 6 months, 12)
- Restenosis(Time Frame: 12 months)
- Quality of Life (QoL)(Time Frame: Baseline, 1 month, 6 months, 12 months)
- Procedure success(Time Frame: Discharge)
- Device success(Time Frame: During procedure)
- Length of Hospital Stay(Time Frame: at Discharge)
研究者
Dr Ankur Phatarpekar
Symbiosis Speciality Hospital