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

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

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.

Study Overview

• Status: Completed
• Conditions: Femoropopliteal Occlusive Disease
• Intervention / Treatment: Procedure: endovascular treatment

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 Type: Observational
• Enrollment (Actual): 1518

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 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
5. If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled
6. For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery
7. 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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 B：TASC D lesion with common femoral artery involved; Chronic total occlusions >20cm with common femoral artery involved (100 cases)	Procedure: endovascular treatment; 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 C：TASC D lesion with proximal popliteal artery involved; Chronic total occlusions >20cm with proximal popliteal artery involved (300 cases)	Procedure: endovascular treatment; 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 D：TASC D lesion with distal popliteal artery involved; Chronic total occlusions >20cm with distal popliteal artery involved (200 cases)	Procedure: endovascular treatment; 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events (MAE)	major adverse events including major adverse limb events (MALE) or death	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical-driven Target lesion reintervention rate	Target lesion reintervention rate	24 months
Procedural success rate	Procedural 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 limb events (MALE)	Major adverse limb events (MALE) including clinically-driven target lesion revascularization (CD-TLR) and major amputation	24 months
Incidence of major amputation	Major amputation defined as above-ankle amputation	24 months
All-cause mortality	All-cause mortality defined as death from any cause	24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): August 31, 2026

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: endovascular treatment; Femoropopliteal Occlusive Disease
• Other Study ID Numbers: The Oriental Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No