NCT06197022Unknown不适用
Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
University National Heart Hospital2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
This is a prospective, single-center, single-arm study to evaluate the feasibility and safety of the combination of Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the treatment of diffuse, small vessel coronary artery disease. The objective of the study is to demonstrate the feasibility and safety of the combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patientsaged≥18years.
- •Presence of epicardial coronary artery disease with lesion length ≥ 20 mm and vessel diameter less than 2.75 mm and more than 1.5 mm with diameter stenosis >50% by visual evaluation.
排除标准
- •Life expectancy < 2 years
- •Left ventricular EF ≤40%
- •Pregnantorlactatingfemales.
- •Moderate and moderate-to-severe valvular heart disease.
- •Hemodynamic instability.
- •Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
- •Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, bivalirudin, prasugrel, ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil, PVP or any contrast media.
- •Patients in whom anti-platelet and/or anti-coagulant therapy are contraindicated.
- •Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- •Transplant patients.
- •Patients with calcified lesion requiring other type of treatment such as Rotational Atherectomy.
- •Unprotected left main coronary artery lesions
- •Coronary artery spasm in the absence of a significant stenosis.
- •Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 12 months
Composite of non-fatal MI, cardiovascular death, and target lesion revascularization
次要结局
- Target Vessel Failure (TVF)(3 months, 6 months, 12 months, 24 months, 36 months)
- Cardiovascular Death(3 months, 6 months, 12 months, 24 months, 36 months)
- Target Lesion Revascularization (TLR)(3 months, 6 months, 12 months, 24 months, 36 months)
- Non-fatal Myocardial Infarction(3 months, 6 months, 12 months, 24 months, 36 months)
- Restenosis(3 months)
- Major bleeding(3 months, 6 months, 12 months, 2 years and 3 years)
- Quality of Life Score(Baseline, 3 months, 6 months, 12 months)
- Device success(During the procedure)
研究者
Dobrin Vassilev
Professor
Medica Cor Heart Hospital
研究点 (2)
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