Physician-initiated, Prospective, Multi-center, Observational Study: The Safety and Efficiency Result of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Amputation-free survival
研究概览
简要总结
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
详细描述
According to the Trans-Atlantic Inter-Society Consensus (TASC) II guidelines, acute arterial occlusion which in stage IIb was recommended for thrombectomy. However, with the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, stage IIb patients and some subacute thromboembolic lesions were also effective in some retrospective studies.
Despite The shift of Endovascular-first strategy has been documented in recent literature. There still lack evidence to support either approach have a significant advantage over the thrombectomy. And stage IIb lesions and subacute lesions are often excluded in prospective clinical trials. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Amputation-free survival
时间窗: post-interventional 12months
The amputation-free survival after endovascular surgery
Adverse events at post-interventional 1months
时间窗: post-interventional 1 months
the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.
次要结局
- Technical success rate(Post operation up to 1 day)
- Clinical-driven Target lesion reintervention(CD-TLR) rate(post-interventional 12 months)
- Clinical-driven Target vascular reintervention(CD-TVR) rate(post-interventional 12 months)
- The total time used in the operation(Intraoperative)
- Primary patency(PP)of the lesions(post-interventional 12 months)
- Changes of quality of life assessed by VascuQol scale(post-interventional 12 months)
- Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions)(2 years)
研究者
Fangxin
Hospital director
Hangzhou Cancer Hospital