Prospective Study of Bioresorbable Vascular Scaffold Treatment With Scoring Balloon Pre-dilatation in Patients With In-stent Restenosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up
研究概览
简要总结
Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the treatment of patients suffering from ISR after scoring balloon pre-dilatation.
详细描述
Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, data on the value of BVS in patients with ISR is scarce. BVS are very effective to inhibit neointimal proliferation and they avoid the need of implanting a new permanent metal layer. Accordingly, currently, there is a major interest to elucidate the potential value of BVS in patients with ISR. The use of scoring balloon pre-dilatation has not been studied previously in this setting.
This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS with scoring balloon pre-dilatation. BVS will be implanted in selected patients (fulfilling inclusion and exclusion criteria) presenting with either BMS-ISR or DES-ISR. Care will be paid to ensure device optimization. Scoring balloon pre-dilatation is mandatory. Angiographic follow-up will be obtained at 6-9 months. A centralized angiographic corelab will be used to provide QCA measurements. Clinical follow-up will be also obtained at 1 year and then yearly. Clinical events will be adjudicated by an independent Clinical Event Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-stent restenosis with ischemia. Signed Informed Consent IRB approval
- •INCLUSION CRITERIA:
- •Age > 20 and < 85 years of age
- •Acceptance of late angiographic evaluation
- •Angina or objective evidence of ischemia
- •ISR (>50% diameter stenosis on visual assessment)
- •Previous stent location known
排除标准
- •Inclusion in other clinical research protocol
- •Allergy to antiplatelet agents
- •Women in childbearing age
- •Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy
- •Recent myocardial infarction
- •Time from index stent implantation < 1 month
- •Anticipated difficulties for late angiographic evaluation
- •Stent thrombosis or large thrombus within the stent
- •Angiographic failure during initial stent implantation or persistence or large dissection.
- •Severe tortuosity or calcification or major difficulties during previous stent implantation
- •Vessel diameter < 2.25 mm (visual assessment)
- •Stenosis outside stent stent edge (edge ISR are eligible)
- •Very diffuse ISR (>30 mm in length)
结局指标
主要结局
Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up
时间窗: angiographic follow-up at 6-9 months
This is a single arm study and results will be analyzed this arm. However, the angiographic and clinical results will be also compared with those obtained in other arms of previous RIBS trials. In particular results will be compared with those found in the RIBS VI study.
Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)
时间窗: 1 year of clinical follow-up
This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies. The occurrence of ANY of these events will qualify for the combined event. That is, Cardiac death OR Myocardial Infarctio OR target vessel revascularization. (for the cobined end point the first event will be censored for each patient and other subsequent events will not apply). For time related statistics, the first event will be censored in the KM curves. In addition to that, the time and occurrence of each individual event will be also analyzed. The same strategy will be followed for the other combined clinical outcome measures that, again, are classically defined in this field.
次要结局
- Loss index(6-9 months)
- Acute gain(procedure)
- Percent diameter stenosis(6-9 months)
- Cardiac death(1 year, 2 years, 3 years, 4 years, 5 years)
- Restenosis rate(6-9 months)
- Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization)(1 year, 2 years, 3 years, 4 years, 5 years)
- Myocardial infarction(1 year, 2 years, 3 years, 4 years, 5 years)
- Stent thrombosis(1 year, 2 years, 3 years, 4 years, 5 years)
- Minimal lumen diameter(procedure)
- Late loss(6-9 months)
- Target vessel revascularization(1 year, 2 years, 3 years, 4 years, 5 years)
- Net gain(6-9 months)
- Major bleeding(1 year, 2 years, 3 years, 4 years, 5 years)
- Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization)(1 year, 2 years, 3 years, 4 years, 5 years)
- Total mortality(1 year, 2 years, 3 years, 4 years, 5 years)
- Target lesion revascularization(1 year, 2 years, 3 years, 4 years, 5 years)
研究者
Fernando Alfonso
MD
Spanish Society of Cardiology