Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 主要终点
- absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention
研究概览
简要总结
Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1) short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.
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
- •PAOD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4
- •Multiple (>1) short (focal; >1 and < 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery
- •Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines
- •Unilateral occlusive disease
排除标准
- •Patients with PAOD Rutherford category 5 and 6
- •Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat
- •Bilateral lesions with treatment indication
- •Contra-indication for anticoagulant therapy
- •Renal insufficiency (MDRD < 50 ml/min)
- •Life expectancy < 6 months
- •Known contrast allergy
- •Pregnancy
- •Unable to complete a questionnaire in the home language
研究组 & 干预措施
Short spot stenting
Short spot stenting
干预措施: Short spot stenting (Procedure)
Long lesion stenting
Long lesion stenting
干预措施: Long lesion stenting (Procedure)
结局指标
主要结局
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention
时间窗: 1 year
次要结局
未报告次要终点
研究者
Marc van Sambeek
MD, PhD, vascular surgeon
Catharina Ziekenhuis Eindhoven