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

NCT04698304 | Active Not Recruiting

• 1 other identifier: The Oriental Study
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoropopliteal Occlusive Disease

Keywords

Femoropopliteal Occlusive Disease; endovascular treatment; patency rate

Outcome Measures

Primary Outcomes (4)

• Technical success rate

  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

  7 days

• Incidence of major adverse events

  major adverse events

  36 months

• Target vessel patency rate evaluated by postoperative ultrasound

  Target vessel patency rate

  36 months

• Clinical-driven Target lesion reintervention rate

  Target lesion reintervention rate

  36 months

Secondary Outcomes (2)

• 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

Study Arms (5)

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)

Procedure: endovascular treatment

Group B：TASC D lesion with common femoral artery involved

Chronic total occlusions \>20cm with common femoral artery involved (100 cases)

Procedure: endovascular treatment

Group C：TASC D lesion with proximal popliteal artery involved

Chronic total occlusions \>20cm with proximal popliteal artery involved (300 cases)

Procedure: endovascular treatment

Group D：TASC D lesion with distal popliteal artery involved

Chronic total occlusions \>20cm with distal popliteal artery involved (200 cases)

Procedure: endovascular treatment

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)

Procedure: endovascular treatment

Interventions

endovascular treatment PROCEDURE

All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods according to the characteristics of the lesions. For example: (a) Plain old balloon angioplasty; (b) Drug-coated balloon angioplasty; (c) Drug-coated balloon angioplasty + provisional stenting; (d) Bare-metal stent implantation; (e) Stent graft implantation; (f) Directional atherectomy + drug-coated balloon angioplasty, (g) Drug -eluting stent.

Group A：TASC C lesion group; Group B：TASC D lesion with common femoral artery involved; Group C：TASC D lesion with proximal popliteal artery involved; Group D：TASC D lesion with distal popliteal artery involved; Group E：TASC D lesion with popliteal artery and proximal trifurcation vessels involved

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with TASC C, D femoropopliteal lesions who undergoing endovascular treatment

You may qualify if:

• Patients over 18 years old
• Patients with Rutherford classification range from 3 to 6
• The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Huashan Hospital: collaborator
• Qingdao Haici Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• RenJi Hospital: lead
• Second Affiliated Hospital of Suzhou University: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: January 6, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (1)