Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 6
- 主要终点
- Percent in-segment diameter stenosis at follow-up angiography
研究概览
简要总结
The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).
详细描述
The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus.
Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions.
The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.
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 ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
- •Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
- •In women with childbearing potential a negative pregnancy test is mandatory.
排除标准
- •Age < 18 years.
- •Cardiogenic shock.
- •Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- •Target lesion located in the left main trunk or bypass graft.
- •Target lesion located in small vessel (vessel size < 2.0 mm).
- •Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- •Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min).
- •Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome.
- •Pregnancy (present, suspected or planned) or positive pregnancy test.
- •Previous enrollment in this trial.
- •Patient's inability to fully comply with the study protocol.
结局指标
主要结局
Percent in-segment diameter stenosis at follow-up angiography
时间窗: 6-8 months
次要结局
- In-segment binary angiographic restenosis(6-8 months)
- Incidence of thrombosis(1 and 2 years)
- In-segment minimal luminal diameter(6-8 months)
- Combined incidence of death or myocardial infarction(1 and 2 years)