Drug Eluting Balloon Angioplasty in Tunisian Population Versus Everolimus Platinum Chrome Stent
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- late lumen loss (LLL)
研究概览
简要总结
Randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (LLL) at 12 months in Tunisian population undergoing coronary percutaneous intervention between Drug Eluting Balloon treated group and Everolimus platinum chrome stent treated group.
详细描述
Drug eluting stents (DES) leave a permanent metal implant that interferes with vasomotion, endothelial function and vascular remodeling. the rigid structure and the pharmacological properties of DES could overcome acute complications related to balloon dilation and late complications related to in-stent restenosis. However, they do not restore normal arterial function after the procedure.
Drug eluting balloons (DEB) offer an alternative to the implantation of a durable material. They release a transient antiproliferative drug. They promise potential advantages over DES as:
- an ad integrum restitution of the endothelium and its vasomotor properties.
- a reduction of late thrombosis risk.
- the possibility of grafting on the treated segment.
- avoid the problems of side-branch trapped in the treatment of bifurcations.
- improve the profitability of non-invasive imaging (coroscanner, magnetic resonance imaging) during patient follow-up.
DEB is validated for the treatment of in-stent restenosis, especially focal and on small caliber arteries. The use of DEB in de novo lesions has been the subject of several studies. This therapeutic option should be evaluated in the Tunisian context The aim of this clinical trial is to compare the results of angioplasty by DEB (SEQUENT PLEASE) versus last generation DES: coronary stent system in platinum chromium alloy with everolimus elution (Promus Premier and Promus Elite) The Primary endpoint: late lumen loss at 12 months. The Secondary endpoint: the major cardiovascular event rate (MACE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with silent ischemia, stable angina, unstable angina, or non-Q wave myocardial infarction.
- •a de Novo lesion on a never treated native artery.
- •A reference artery diameter between 2 mm and 4 mm.
- •Non-inclusion criteria
- •Patients with STEMI in the acute phase or presenting a cardiogenic shock.
- •Patients with an allergy or a contraindication to double anti-platelet aggregation.
- •Pre-menopausal patients not using regularly an oral contraceptives or breast-feeding .
- •Patients with severe comorbidity or with an estimated survival of less than 12 months.
- •Dissected lesions or spontaneous dissections other than grade A or B requiring DES angioplasty.
- •In-stent restenosis.
- •Thrombotic lesions.
排除标准
- 未提供
结局指标
主要结局
late lumen loss (LLL)
时间窗: Follow-up coronary angiography at 12 months after the percutaneous coronary intervention
late lumen loss between Drug Eluting Balloon treated group and Drug Eluting Stents treated group evaluated by quantitative coronary analysis
次要结局
- rate of major adverse cardiac events (MACE)(6 months and 12 months after percutaneous coronary intervention)