NCT06416644进行中（未招募）不适用
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Hospital do Divino Espírito Santo de Ponta Delgada29 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 29
- 主要终点
- Target Lesion Revascularization (TLR)
研究概览
简要总结
The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.
详细描述
Primary endpoints (at hospitalization, 30 days, 6 months, 1 year)
- Limb salvage
- Target lesion revascularization (TLR)
- Freedom from major adverse limb events (MALE - Major Amputation, any index limb revascularization)
Secondary endpoints (at hospitalization, 30 days, 6 months, 1 year)
- Freedom from Major adverse cardiovascular events (5-point endpoint: Stroke, myocardial infarction/Acute coronary syndrome, Any limb revascularization, Decompensated Congestive Heart Failure, Cardiovascular death1)
- All-cause death / Cardiovascular death
- Primary Patency(defined by Duplex Ultrassound Scan [DUS]2) Primary-Assisted Patency, Secondary Patency
- Ankle-Brachial Index (ABI)
- Rutherford-Becker classification
Inclusion Criteria Clinical
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of symptomatic obstructive peripheral arterial disease.
- •All-comer patients undergoing endovascular lower-limb revascularization with Supera® stent implantation in the superficial femoral (SFA) or popliteal arteries.
- •Patient or legal representative understand the SupPORT registry procedures, and have voluntarily provided informed written consent regarding their participation.
- •Participant is willing to remain in the SupPORT Registry for at least 1 year.
- •Target lesion is a primary atherosclerotic lesion or a restenosis occurring in a non-stented of the SFA or the popliteal artery, distancing at least ≥ 1 cm from any previously implanted vascular stent.
- •Target lesion causes a ≥50% arterial obstruction (visually confirmed on digital subtraction angiography).
排除标准
- •• Any contraindication for peri-interventional or post-interventional anti-thrombotic therapy (including, but not restricted to Non-fractioned heparina, low-molecular weight heparina [LMWH], Clopidogrel, Ticagrelol, Ticlopidine, Acetylsalicylic acid, dipiridamol, direct thrombin [factor II] or factor Xa inhibitors, vitamin-K antagonists).
- •Participation in other research study that may influence obtained results.
- •Pregnant or breastfeeding women, or expected pregnancy to occur during the study period.
- •Treatment of intrastent restenosis/occlusion of previous peripheral vascular stent.
- •Non-corrected hemodynamically significant obstructive arterial disease of the ipsilateral inflow arteries (aorta, iliac arteries)
结局指标
主要结局
Target Lesion Revascularization (TLR)
时间窗: 1 year
Number of target lesions requiring re-intervention
Freedom from major limb amputation
时间窗: 1 year
Number of limbs surviving without above ankle amputation
MALE - Major Adverse Limb Event
时间窗: 1 year
Composite endpoint Major Amputation, any index limb revascularization
次要结局
- Primary Patency, Primary Assisted Patency, Secondary Potency(1 year)
- Ankle-Brachial Index(1 year)
- Cardiovascular-related death(1 year)
- All-cause Death(1 year)
- Rutherford-Becker Classification(1 year)
- MACE - Major Adverse Cardiovascular Event(1 year)
研究者
Dr. Nelson Oliveira
Principal Investigator
Hospital do Divino Espírito Santo de Ponta Delgada
研究点 (29)
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