NCT01587482已完成不适用
PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Target Lesion Revascularization (TLR)
研究概览
简要总结
Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.
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
- •Age ≥18 years old
- •Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5
- •Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions
- •Symptoms related to SFA ISR defined by PSVR > 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study
- •The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection)
- •Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery)
- •The target lesion must no extend beyond the stent margin
- •Successful crossing of the target lesion, inflow and outflow lesions with a guidewire
- •Patient belongs to the French health care system
- •Written informed consent
排除标准
- •No atheromatous disease
- •Asymptomatic lesion
- •Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel
- •Acute limb ischemia
- •Patient on oral anticoagulation therapy
- •Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc.
- •Life expectancy < 1 year
- •Patient involved in another trial
- •Refusing patient
- •Pregnancy
结局指标
主要结局
Target Lesion Revascularization (TLR)
时间窗: at 1 year
次要结局
- Length of hospitalization stay(at 1 year)
- Major Adverse Events through(at 1 year)
- clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization(at 1, 3, 6, 9, 12 and 18 months)
- peak systolic velocity index(at 1 year)
- Target extremity revascularization (TER)(at 1, 3, 6, 9, 12 and 18 months after surgery)
- drug relief success without balloon break(during surgery)
- clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery(at 1, 3, 6, 9, 12 and 18 months)
- peak systolic velocity index without Target Lesion Revascularization(at 1, 3, 6, 9, 12 and 18 months)
- post-angioplasty restenosis(at 1, 3, 6, 9, 12 and18 months after surgery)
- Quality of life assessment by EQ5D questionnaire(at 1, 3, 6, 9, 12 and 18 mois after surgery)
- intra-stent restenosis(at 1, 3, 6, 9, 12 and 18 months after surgery)
研究者
研究点 (1)
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