Physician-initiated, Prospective, Multi-center，Observational Study: The Efficacy of Endovascular Treatment in Femoropopliteal Occlusive Disease (FPOD) With TransAtlantic InterSociety Consensus (TASC) C and D Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,518
- 试验地点
- 1
- 主要终点
- Clinical-driven Target lesion reintervention rate
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 challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
The TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
详细描述
According to the TASC II guidelines, TASC D lesions was recommended for primary endovascular revascularization, TASC C lesions for surgical revascularization in patients with appropriate perioperative risk and available conduit. However, Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
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 other. And TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal 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
- •Patients over 18 years old
- •Patients with Rutherford classification range from 3 to 6
- •If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study
- •The guide wire should pass through the lesion of femoropopliteal artery, and further endovascular treatment is performed. In this study, we did not limit the methods of the guide wire passing through the target lesion
- •If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled
- •For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery
- •Informed consent signed by patients
排除标准
- •Patients who are unwilling or refuse to sign the informed consent form
- •Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism
- •Patients with thromboangiitis obliterans
- •Patients with failure of endovascular treatment, and transferred to bypass surgery
- •Patients who underwent surgical atherectomy for common femoral artery occlusive lesions
- •Patients with known allergy to heparin, low molecular weight heparin and contrast agents
- •Patients who have been enrolled in other clinical trials in the past 3 months
- •Women during pregnancy and lactation
- •Patients with other diseases that may lead to difficulties in the trial or significantly shorten the life expectancy (< 3 years), such as tumors, severe liver disease, cardiac insufficiency
研究组 & 干预措施
Group A：TASC C lesion group
Multiple stenoses or occlusions totaling >15cm or recurrent stenoses or occlusions that need treatment after endovascular interventions (300 cases)
干预措施: endovascular treatment (Procedure)
Group B：TASC D lesion with common femoral artery involved
Chronic total occlusions >20cm with common femoral artery involved (100 cases)
干预措施: endovascular treatment (Procedure)
Group C：TASC D lesion with proximal popliteal artery involved
Chronic total occlusions >20cm with proximal popliteal artery involved (300 cases)
干预措施: endovascular treatment (Procedure)
Group D：TASC D lesion with distal popliteal artery involved
Chronic total occlusions >20cm with distal popliteal artery involved (200 cases)
干预措施: endovascular treatment (Procedure)
Group E：TASC D lesion with popliteal artery and proximal trifurcation vessels involved
Chronic total occlusion of popliteal artery (P1-3 segment) with proximal trifurcation vessels involved (100 cases)
干预措施: endovascular treatment (Procedure)
结局指标
主要结局
Clinical-driven Target lesion reintervention rate
时间窗: 36 months
Target lesion reintervention rate
Technical success rate
时间窗: 7 days
Technical success refers to 1. Establishment of continuous blood flow, no early occlusion, acute thrombosis or reintervention driven by target lesion within 7 days after operation
Incidence of major adverse events
时间窗: 36 months
major adverse events
Target vessel patency rate evaluated by postoperative ultrasound
时间窗: 36 months
Target vessel patency rate
Incidence of major adverse events (MAE)
时间窗: 24 months
major adverse events including major adverse limb events (MALE) or death
次要结局
- Clinical-driven Target lesion reintervention rate(24 months)
- Procedural success rate(7 days)
- Incidence of major adverse limb events (MALE)(24 months)
- Incidence of major amputation(24 months)
- All-cause mortality(24 months)
- Clinical-driven Target lesion reintervention rate(24 months)
- Direct medical expenses (3-year cumulative hospitalization expenses and endovascular expenses related to target lesions)(36 months)