Comparison of the Efficacy of Paclitaxel-releasing Balloon Catheter System Versus the Everolimus-Eluting Stent System for Treatment of In-Stent Restenosis Lesions - Harmonizing Optimal Strategy for Treatment of In-Stent Restenosis Lesions (The HOST-ISR Trial) -
试验速览
- 阶段
- 4 期
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Late luminal loss in the analysis segment
研究概览
简要总结
In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era. The current consensus in treating ISR is implantation of another DES into the restenosed segment. However the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions. HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES. The primary endpoint will be in-segment late luminal loss at 9 months angiographical follow-up.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18y
- •Significant ISR lesion (>50% by visual estimate) of previously stented de novo coronary artery
- •Evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia) or ISR with diameter stenosis > 70%
- •Written, informed consent
- •Target lesion(s) located in a native coronary artery within a previously stented lesion with previous stent diameter of ≥ 2.5 mm and ≤ 4.00 mm
- •Target lesion(s) amenable for percutaneous coronary intervention
排除标准
- •Hypersensitivity to aspirin, clopidogrel, heparin, sirolimus, paclitaxel or radiocontrast media
- •Systemic sirolimus use within 12 months
- •Female of childbearing potential
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia)
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
- •Non-cardiac co-morbid conditions present with life expectancy <1 year or that may result in protocol non-compliance
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- •ISR of left main coronary artery
- •Restenosis of two stented bifurcation lesion
结局指标
主要结局
Late luminal loss in the analysis segment
时间窗: 9 months
Analysis segment is defined as +/- 5mm of the previous stented/inflated segment of the vessel
次要结局
- % diameter stenosis in the analysis segment & in the inflation/in-stent segment(9 months)
- Late luminal loss in the inflation/in-stent segment(9 months)
- Time interval from device insertion to initiation of deployment(0 days)
- Periprocedural myocardial infarction(3 days)
- Stent thrombosis(1, 2 years)
- Target lesion/vessel revascularization, myocardial infarction(1, 2 years)
- Neointimal volume, % neointimal volume, % volume obstruction(9 months)