SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 15
- 主要终点
- Primary Patency Rate
研究概览
简要总结
The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.
详细描述
The present study is designed as a prospective, open label, observational study.
The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.
Patients elected for endovascular revascularization with SuperSub strategy will be asked their written consent to the use of their personal data.
Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in symptomatic patients, as clinically indicated and with the aim for a new treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •General Inclusion Criteria:
- •Patients with CLI and TASC C-D Fem-Pop CTO's
- •Age ≥18 years
- •Patient has signed an approved consent form
- •Patients without previous stenting of the Fem-Pop segment
- •Angiographic Inclusion Criteria:
- •Patent and hemodynamically normal iliac and common femoral arteries.
- •At least one patent and healthy tibial vessel runoff to the foot.
- •Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure
- •Rutherford Category 4, 5 or 6
- •Subintimal crossing of the occluded Fem-Pop vessels
- •Supera Stenting From healthy to healthy arterial segment.
排除标准
- •Patient unwilling or unlikely to comply with Follow-Up schedule
- •Endoluminal crossing of the CTO
- •Inability to stent from "healthy to healthy" arterial segments.
- •Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)
结局指标
主要结局
Primary Patency Rate
时间窗: 24 months
Primary Patency is defined as freedom from clinically driven TLR (CD-TLR) defined as repeat percutaneous intervention or surgical bypass graft to treat an angiographic significant restenosis (\>50%) at the level of the treated lesion ±10 mm (proximally and/or distally)
次要结局
- Stent integrity assessment(24 months)
- Primary Sustained Clinical Improvement(6,12 and 24 months vs baseline)
- Quality of Life (EQ-5D-5L Questionnaire)(24 months)
- Incidence of Major Adverse Events(24 months)
- Quality of Life improvement (SF12 Questionnaire)(12 months)
- Quality of Life improvement(24 months)
- Amputation Rates(24 months)
- Freedom from Restenosis(24 months)
- Composite of All Major Adverse Events(24 Months)