Status:
ACTIVE_NOT_RECRUITING
The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Xuanwu Hospital, Beijing
Second Affiliated Hospital of Suzhou University
Conditions:
Femoropopliteal Occlusive Disease
Eligibility:
All Genders
18+ years
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04698304
Start Date
January 1 2021
End Date
December 31 2025
Last Update
December 8 2025
Active Locations (1)
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1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127