Clinical trial NCT04698304: The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Femoropopliteal Occlusive Disease
Keywords: Femoropopliteal Occlusive Disease
endovascular treatment
patency rate
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: Xuanwu Hospital, Beijing
name: Second Affiliated Hospital of Suzhou University
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Chengdu University of Traditional Chinese Medicine
First posted: 2021-01-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with TASC C, D femoropopliteal lesions who undergoing endovascular treatment

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 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.

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 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.

Eligibility criteria: 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, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with the digital artery below 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

Primary outcomes:
measure: Technical success rate
timeFrame: 7 days
measure: Incidence of major adverse events
timeFrame: 36 months
measure: Target vessel patency rate evaluated by postoperative ultrasound
timeFrame: 36 months
measure: Clinical-driven Target lesion reintervention rate
timeFrame: 36 months
Secondary outcomes:
measure: Target vessel patency rate evaluated by postoperative ultrasound
timeFrame: 24 months
measure: Clinical-driven Target lesion reintervention rate
timeFrame: 24 months
measure: Direct medical expenses (3-year cumulative hospitalization expenses and endovascular expenses related to target lesions)
timeFrame: 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: