The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions

Recruiting

• Conditions: Femoropopliteal Occlusive Disease
• Interventions: Procedure: endovascular treatment

• Registration Number: NCT04698304
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-19
• Study Start: 2021-01-01
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Patients over 18 years old
2. Patients with Rutherford classification range from 3 to 6
3. If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study
4. The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with the digital artery below the ankle
5. 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
6. If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled
7. For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery
8. Informed consent signed by patients

Exclusion Criteria

1. Patients who are unwilling or refuse to sign the informed consent form
2. Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism
3. Patients with thromboangiitis obliterans
4. Patients with failure of endovascular treatment, and transferred to bypass surgery
5. Patients who underwent surgical atherectomy for common femoral artery occlusive lesions
6. Patients with known allergy to heparin, low molecular weight heparin and contrast agents
7. Patients who have been enrolled in other clinical trials in the past 3 months
8. Women during pregnancy and lactation
9. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A：TASC C lesion group	endovascular treatment	Multiple stenoses or occlusions totaling \>15cm or recurrent stenoses or occlusions that need treatment after endovascular interventions (300 cases)
Group C：TASC D lesion with proximal popliteal artery involved	endovascular treatment	Chronic total occlusions \>20cm with proximal popliteal artery involved (300 cases)
Group D：TASC D lesion with distal popliteal artery involved	endovascular treatment	Chronic total occlusions \>20cm with distal popliteal artery involved (200 cases)
Group E：TASC D lesion with popliteal artery and proximal trifurcation vessels involved	endovascular treatment	Chronic total occlusion of popliteal artery (P1-3 segment) with proximal trifurcation vessels involved (100 cases)
Group B：TASC D lesion with common femoral artery involved	endovascular treatment	Chronic total occlusions \>20cm with common femoral artery involved (100 cases)

Primary Outcome Measures

Name	Time	Method
Clinical-driven Target lesion reintervention rate	36 months	Target lesion reintervention rate
Technical success rate	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	36 months	major adverse events
Target vessel patency rate evaluated by postoperative ultrasound	36 months	Target vessel patency rate

Secondary Outcome Measures

Name	Time	Method
Target vessel patency rate evaluated by postoperative ultrasound	24 months	Target vessel patency rate
Clinical-driven Target lesion reintervention rate	24 months	Target lesion reintervention rate
Direct medical expenses (3-year cumulative hospitalization expenses and endovascular expenses related to target lesions)	36 months	Direct medical expenses

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China