Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 主要终点
- Angiographic late lumen loss at 9 months
研究概览
简要总结
The primary objective of this study is to demonstrate superiority of the Absorb scaffold compared to the Sequent Please Drug Coated Balloon when treating patients with In-Stent-Restenosis (ISR).
详细描述
Absorb ISR is randomized-controlled trial of Absorb scaffold vs. Sequent Please drug coated balloon in an all-comers population with in-stent-restenosis. The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients.
Repeat coronary angiography will be performed 9 months post intervention in all subjects. Optical coherence tomography will be performed at baseline and at 9 months in both groups.
All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS).
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis > 70 % and/or Fractional Flow Reserve < 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in BMS (bare metal stent), DES (drug eluting stent) or BVS, ISR in lesion previously treated by POBA (plain old balloon angioplasty), DEB or additional stent implantation.
- •Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention.
排除标准
- •Difficulty with deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
- •Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb).
研究组 & 干预措施
Sequent Please Drug Coated Balloon Group
For Sequent Please Group, PCI (percutaneous coronary intervention) PCI procedure with Sequent Please inflation will be performed - drug eluting balloon will be used in the narrowed part of the artery. This method of treatment is one of the standard ones, which is typically used for treatment patients with diagnosis of in stent restenosis, the exact intervention and anesthesia procedures will be performed according to physician's usual practice. For bailout situation Xience stent implantation is possible.
干预措施: Sequent Please inflation (Procedure)
Absorb Stent Group
Absorb scaffold group will be treated by PCI procedure with Absorb BVS implantation - implantation of bioresorbable vascular scaffold (Absorb). Coronary stent implantation for treatment in stent restenosis is one of the standard method of treatment this disease, but Absorb system has not been investigated in this indication yet.
干预措施: Absorb BVS implantation (Procedure)
结局指标
主要结局
Angiographic late lumen loss at 9 months
时间窗: 9 months
Late lumen loss will be calculated based on index and control coronary angiography.
次要结局
- - Incidence of in-stent-restenosis, target lesion failure, target vessel revascularisation, stent thrombosis in in-hospital and long-term observation(9 months)
- - Early, late and very late probable or definite stent thrombosis(9 months)
- - Cardiac and non-cardiac death in both groups(9 months)
- - Result of index procedure assessment in OCT post procedure - struts apposition assessment.(During index procedure.)
- - Result of index procedure assessment in OCT post procedure - dissections.(During index procedure.)
- - Comparison of rate of restenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))(9 months)
- - OCT assessment of long-term study results - lumen area.(9 months)
- - Result of index procedure assessment in OCT post procedure - stent area.(During index procedure.)
- - Incidence of periprocedural complications: unplanned use of GP IIb/IIIa (Glycoprotein IIb/IIIa) inhibitors, vessel rupture, side branch occlusion, peri-procedural myocardial infarction(9 months)
- - Comparison of minimal luminal diameter between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))(9 months)
- - Comparison of diameter stenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))(9 months)
- - Assessment of possibility vessel measurement and stent diameter/length choice based on this measurement performed in OCT (Optical Coherence Tomography)(During index procedure.)
- - Result of index procedure assessment in OCT post procedure - stent expansion index.(During index procedure.)
- - OCT assessment of long-term study results - struts apposition assessment.(9 months)
- - Lumen volume change between index and 9M (nine months) FU in OCT.(9 months)
- - Result of index procedure assessment in OCT post procedure - lumen area.(During index procedure.)
- - OCT assessment of long-term study results - stent area.(9 months)
- - OCT assessment of long-term study results - lumen volume.(9 months)
- - OCT assessment of long-term study results - neointimal volume.(9 months)
- - Minimal lumen area change between index and 9M (nine months) FU in OCT.(9 months)
研究者
Wojciech Zasada
Clinical Trial Administrator
Luzerner Kantonsspital