DARE-Trial: Drug Eluting bAlloon for In-stent REstenosis. Multi-center, Randomized Trial to Study the Effect of the SeQuent Please Drug-eluting Balloon Versus the Xience Prime Drug-eluting Stent for the Treatment of In-stent Restenosis.
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 11
- 主要终点
- The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI
研究概览
简要总结
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.
详细描述
Background of the study:
Coronary in-stent restenosis is commonly treated by using a drug eluting stent (DES). There are, however, some concerns about the safety of drug eluting stents, in particular with respect to delayed healing, chronic inflammatory reaction, and late or very late stent thrombosis. It is unknown whether the current treatment with another layer of stents may add to the risk of stent thrombosis or reoccurrence of restenosis. Therefore, the relatively new drug-eluting balloons may provide an alternative for treatment of in-stent restenosis, avoiding a double stent layer. The expected advantages of such drug-eluting balloons over stents are the ease of access of the lesion, the absence of a multiple stent layer, and the shorter necessity of the use of dual antiplatelet therapy. Several studies have demonstrated safety and efficacy of the Sequent Please drug-eluting balloon (DEB). Whether the drug eluting balloon is as effective as a drug eluting stent in preventing re-restenosis is not known.
Study design:
The study is designed as an multi-center, randomized, prospective two-arm trial with either PCI with a drug eluting balloon or a drug eluting stent for in-stent restenosis. Blinded evaluation of endpoints by independent core laboratory.
Study population:
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 (Participant)
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
- •Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts
- •Restenosis of any type of stent; all drug-eluting stents or bare metal stents
- •Restenosis must be present > 50% in-stent and < 5 mm out of the stent
- •A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation
- •Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES
- •Amendable to dual antiplatelet treatment for the duration of 1 year
- •Patients must be ≥ 18 years of age
- •Patients must be able to understand the aim of the study, including risks, benefits and treatment alternatives
- •Patients must agree to undergo a follow-up angiogram at 6 months (± 1 month)
- •Patients must agree to undergo a clinical follow-up at 30 days, 6 months, 1, 2, 3, 4, and 5 years
排除标准
- •The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure is considered an exclusion criterion for this study
- •Patients have to meet the inclusion criteria;
- •Life expectancy less than one year
- •Severe renal insufficiency (glomerular filtration rate <30mL/min), with exception of of patients with renal dialysis
- •Restenosis in a biodegradable stent
- •Restenosis in a non CE marked stent
- •Requirement for PCI in the same vessel or expected in the next 6 months
结局指标
主要结局
The primary objective of this study is the minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI
时间窗: 6 month's after PCI
The primary objective of this study is to determine whether PCI with the SeQuent ® Please DEB versus PCI with the Xience™ Prime DES for the treatment of patients with in-stent restenosis is non-inferior with respect to minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at six months.
次要结局
- In-stent and in-segment percent Diameter Stenosis(6 months)
- In-stent and in-segment Angiographic binary restenosis(6 months)
- Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm(6 months)
研究者
J. Baan
J. Baan, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)