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

Last updated: December 1, 2024
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Treatment

endovascular treatment

Clinical Study ID

NCT04698304
The Oriental Study
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 limbcan be selected for this study

  4. The lower extremity artery needs to have a healthy runoff of no less than 10 cmabove the ankle, and at least one healthy dorsalis pedis artery, medial or lateralplantar artery connected with the digital artery below the ankle

  5. The guide wire should pass through the lesion of femoropopliteal artery, and furtherendovascular treatment is performed. In this study, we did not limit the methods ofthe guide wire passing through the target lesion

  6. If the first-time endovascular treatment is failure, patients undergo endovasculartreatment successfully at the second time, the patients can still be enrolled

  7. For patients with aortoiliac artery lesions, they can be enrolled after thesuccessful reconstruction of aortoiliac artery

  8. Informed consent signed by patients

Exclusion

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 arterialembolism

  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 occlusivelesions

  6. Patients with known allergy to heparin, low molecular weight heparin and contrastagents

  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 orsignificantly shorten the life expectancy (< 3 years), such as tumors, severe liverdisease, cardiac insufficiency

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: endovascular treatment
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Renji Hospital

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

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