Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-eluting Xience V Stent Versus Use of a Paclitaxel-eluting Balloon: Optical Coherence Tomography Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Stent strut coverage and stent strut apposition(assessed with OCT)
研究概览
简要总结
Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study.
A prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.
详细描述
Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.
Aim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES.
Methods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned.
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
- None
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
- •Patient older than 18 years
- •written informed consent available
- •patient eligible for percutaneous coronary intervention
- •patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
- •Target reference vessel diameter measured by QCA: 2-4 mm
- •Target lesion length measured by QCA < 24 mm
- •Target lesion stenosis measured by QCA: > 70%- < 100%
- •Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
排除标准
- •Left ventricular ejection fraction of < 30%
- •Impaired renal function (serum creatinine > 2.0 mg/dl)
- •Target lesion located in bifurcation
- •Previous and/or planned brachytherapy of target vessel
- •Lesion of the left main trunk > 50%, unprotected
- •Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus
- •Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
- •Patients with a life expectancy of less than one year
- •Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
- •Patient currently enrolled in other investigational device or drug trial
- •Patient not able or willing to adhere to follow-up visits
- •Patients who previously participated in this study. -
结局指标
主要结局
Stent strut coverage and stent strut apposition(assessed with OCT)
时间窗: 9 months
次要结局
- Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target vessel revascularisation (TVR) at 12 months Device success(9 months, 12 months, yearly until 5 years)