Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions
2026年9月3日 更新者：ömer faruk topaloglu、Sakarya University
Prospective, Single-Center Evaluation of Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Distal Embolic Protection for Chronic Total Occlusions of the Superficial Femoral Artery
Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment. This study will evaluate a minimally invasive treatment for these blockages.
Approximately 60 adults who require endovascular treatment will undergo placement of a filter beyond the blockage to collect debris. Rotational atherectomy will then be used to remove part of the material causing the blockage, followed by drug-coated balloon angioplasty to widen the artery. A stent may be placed only if needed because of an inadequate treatment result or a procedure-related complication.
Participants will be evaluated by clinical examination and duplex ultrasound at 1, 3, 6, and 12 months. The main goal is to determine how often the treated artery remains open at 12 months. The study will also evaluate technical success, the need for repeat treatment, material captured by the filter, and procedure-related blockage of smaller downstream arteries.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
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。
学习联系方式
- 姓名：ÖMER FARUK TOPALOĞLU, MD
- 电话号码：+90 264 888 40 00
- 邮箱：ofaruktopaloglu@gmail.com
学习地点
-
-
Sakarya
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Adapazarı、Sakarya、土耳其（türkiye）、54100
- Sakarya Training and Research Hospital
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接触：
- ÖMER FARUK TOPALOĞLU, MD
- 电话号码：+90 264 888 4000
- 邮箱：ofaruktopaloglu@gmail.com
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 18 years or older Symptomatic peripheral artery disease classified as Rutherford category 2 to 5 Chronic total occlusion of the superficial femoral artery extending from its origin toward Hunter's canal Clinical indication for endovascular treatment At least one patent distal runoff artery
Exclusion Criteria:
- Acute limb ischemia Severe renal impairment contraindicating iodinated contrast administration Coagulopathy Absence of a patent distal runoff artery
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
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Rotational Atherectomy With Drug-Coated Balloon and Embolic Protection
Participants will undergo placement of a distal embolic protection filter followed by rotational atherectomy and drug-coated balloon angioplasty for chronic total occlusion of the superficial femoral artery.
Bailout stenting may be performed in cases of flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result.
|
After successful crossing of the superficial femoral artery chronic total occlusion, a distal embolic protection filter will be deployed in the distal superficial femoral or popliteal artery.
Rotational atherectomy will be performed to debulk atherosclerotic and thrombotic material, followed by drug-coated balloon angioplasty.
Bailout stenting may be performed for flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months
大体时间：12 months after the index procedure
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The proportion of participants with a patent treated superficial femoral artery segment on duplex ultrasonography, defined as a peak systolic velocity ratio of less than 2.4.
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12 months after the index procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months
大体时间：1, 3, and 6 months after the index procedure
|
The proportion of participants with a patent treated superficial femoral artery segment at each scheduled follow-up, assessed by duplex ultrasonography and defined as a peak systolic velocity ratio of less than 2.4.
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1, 3, and 6 months after the index procedure
|
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Target Lesion Revascularization
大体时间：Through 12 months after the index procedure
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The proportion of participants requiring repeat endovascular or surgical revascularization of the treated SFA segment.
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Through 12 months after the index procedure
|
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Periprocedural Distal Embolization
大体时间：Periprocedural
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The proportion of participants with clinically evident or angiographically confirmed distal embolization associated with the index procedure.
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Periprocedural
|
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Macroscopic Material Captured in the Distal Embolic Protection Filter
大体时间：Immediately after the index procedure
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The proportion of retrieved distal embolic protection filters containing macroscopically visible thrombotic or atheromatous debris.
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Immediately after the index procedure
|
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Technical Success of the Index Procedure
大体时间：At the end of the index procedure
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The proportion of procedures in which the target lesion is successfully crossed and treated with rotational atherectomy and drug-coated balloon angioplasty, with restoration of antegrade flow on final angiography.
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At the end of the index procedure
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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。
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 (估计的)
2026年9月1日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年8月31日
首先提交符合 QC 标准的
2026年9月3日
首次发布 (实际的)
2026年9月4日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SAU-SFA-CTO-2026-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared.
De-identified aggregate study results will be reported in scientific publications; however, no formal data-sharing repository or data-access mechanism has been established for this investigator-initiated, single-center study.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.