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

Femoropopliteal Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04698304
• Other study ID #: The Oriental Study
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2022
• Source: RenJi Hospital
• Contact: Ni Qihong, M.D.
• Phone: +8615801900772
• Email: niqihong1989[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoropopliteal Occlusive Disease

Intervention

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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
RenJi Hospital	Chengdu University of Traditional Chinese Medicine, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Second Affiliated Hospital of Suzhou University, Xuanwu Hospital, Beijing, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of major adverse events	major adverse events	36 months
Primary	Target vessel patency rate evaluated by postoperative ultrasound	Target vessel patency rate	36 months
Primary	Clinical-driven Target lesion reintervention rate	Target lesion reintervention rate	36 months
Secondary	Target vessel patency rate evaluated by postoperative ultrasound	Target vessel patency rate	24 months
Secondary	Clinical-driven Target lesion reintervention rate	Target lesion reintervention rate	24 months
Secondary	Direct medical expenses (3-year cumulative hospitalization expenses and endovascular expenses related to target lesions)	Direct medical expenses	36 months