PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis (PLAISIR)
2016年5月19日 更新者：Nantes University Hospital
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.
研究概览
研究类型
观察性的
注册 (实际的)
53
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Nantes、法国、44093
- Nantes University Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
From December 2011 to December 2012 at 13 hospitals in France, we will include patients with symptomatic atherosclerotic lesions related to superficial femoral artery in-stent restenosis to undergo endovascular repair by paclitaxel drug eluting balloon.
100 patients will be included.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
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drug eluting balloon
In this observationnal study, the intervention of interest is the use of drug eluting balloon in stent restenosis. Only the treated patients were included in this cohort. |
Stenting is 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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Target Lesion Revascularization (TLR)
大体时间：at 1 year
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at 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Major Adverse Events through
大体时间：at 1 year
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at 1 year
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Target extremity revascularization (TER)
大体时间：at 1, 3, 6, 9, 12 and 18 months after surgery
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at 1, 3, 6, 9, 12 and 18 months after surgery
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clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization
大体时间：at 1, 3, 6, 9, 12 and 18 months
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to assess primary maintenance of clinical improvement
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at 1, 3, 6, 9, 12 and 18 months
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peak systolic velocity index without Target Lesion Revascularization
大体时间：at 1, 3, 6, 9, 12 and 18 months
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to assess primary patency
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at 1, 3, 6, 9, 12 and 18 months
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Quality of life assessment by EQ5D questionnaire
大体时间：at 1, 3, 6, 9, 12 and 18 mois after surgery
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at 1, 3, 6, 9, 12 and 18 mois after surgery
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post-angioplasty restenosis
大体时间：at 1, 3, 6, 9, 12 and18 months after surgery
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at 1, 3, 6, 9, 12 and18 months after surgery
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drug relief success without balloon break
大体时间：during surgery
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during surgery
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Length of hospitalization stay
大体时间：at 1 year
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at 1 year
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clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery
大体时间：at 1, 3, 6, 9, 12 and 18 months
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to assess secondary maintenance of clinical improvement
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at 1, 3, 6, 9, 12 and 18 months
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peak systolic velocity index
大体时间：at 1 year
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to assess secondary patency
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at 1 year
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intra-stent restenosis
大体时间：at 1, 3, 6, 9, 12 and 18 months after surgery
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significant whether restenosis >50% and peak systolic velocity index > 2.4
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at 1, 3, 6, 9, 12 and 18 months after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Thierry Reix, PU-PH、Amiens's Univeristy Hospital
- 首席研究员：Eric Ducasse, PU-PH、Pellegrin's University Hospital
- 首席研究员：Patrick Lermusiaux, PU-PH、Lyon's University Hospital
- 首席研究员：Jean-Marc Pernes, Practitioner、Antony's private Hospital
- 首席研究员：Nicolas Louis, PH、Le Raincy-Montfermeuil Hospital
- 首席研究员：Antoine Sauget, Practitioner、Pasteur's private Hospital
- 首席研究员：Philippe Commeau, Practitioner、Ollioules private Hospital
- 首席研究员：Jean-Noel Albertini, PU-PH、St Etienne University Hospital
- 首席研究员：Olivier Planché, PH、Le Plessis-Robinson private hospital (CMC)
- 首席研究员：Max Amor, PH、Essey-les-Nancy Private hospital (Polyclinique Pasteur)
- 首席研究员：Jean-Marie Cardon, Dr、Nimes private Hospital (clinique des fransiscaines)
- 首席研究员：Alain Cardon, PH、Rennes's University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年12月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2012年2月15日
首先提交符合 QC 标准的
2012年4月26日
首次发布 (估计)
2012年4月30日
研究记录更新
最后更新发布 (估计)
2016年5月20日
上次提交的符合 QC 标准的更新
2016年5月19日
最后验证
2016年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PacLitaxel Eluting Balloon Application的临床试验
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Fondazione Evidence per Attività e Ricerche Cardiovascolari...未知