The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions (NCT04698304) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions
China1,000 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Technical success rate
Timeframe: 7 days
2
Incidence of major adverse events
Timeframe: 36 months
3
Target vessel patency rate evaluated by postoperative ultrasound