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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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 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

• 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

Locations
Other Locations
China
Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Ni Qihong, M.D.
niqihong1989@163.com
+8615801900772
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1000
Treatments
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)
Group B:TASC D lesion with common femoral artery involved
Chronic total occlusions \>20cm with common femoral artery involved (100 cases)
Group C:TASC D lesion with proximal popliteal artery involved
Chronic total occlusions \>20cm with proximal popliteal artery involved (300 cases)
Group D:TASC D lesion with distal popliteal artery involved
Chronic total occlusions \>20cm with distal popliteal artery involved (200 cases)
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)
Related Therapeutic Areas
Sponsors
Collaborators: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University, Xuanwu Hospital, Beijing, Chengdu University of Traditional Chinese Medicine, Second Affiliated Hospital of Suzhou University
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov