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

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Femoropopliteal Occlusive Disease

Treatments: Procedure: endovascular treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04698304

The Oriental Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
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

Trial design

1,000 participants in 5 patient groups

Group A：TASC C lesion group

Description:

Multiple stenoses or occlusions totaling \>15cm or recurrent stenoses or occlusions that need treatment after endovascular interventions (300 cases)

Treatment:

Procedure: endovascular treatment

Group B：TASC D lesion with common femoral artery involved

Description:

Chronic total occlusions \>20cm with common femoral artery involved (100 cases)

Treatment:

Procedure: endovascular treatment

Group C：TASC D lesion with proximal popliteal artery involved

Description:

Chronic total occlusions \>20cm with proximal popliteal artery involved (300 cases)

Treatment:

Procedure: endovascular treatment

Group D：TASC D lesion with distal popliteal artery involved

Description:

Chronic total occlusions \>20cm with distal popliteal artery involved (200 cases)

Treatment:

Procedure: endovascular treatment

Group E：TASC D lesion with popliteal artery and proximal trifurcation vessels involved

Description:

Chronic total occlusion of popliteal artery (P1-3 segment) with proximal trifurcation vessels involved (100 cases)

Treatment:

Procedure: endovascular treatment