Femoropopliteal Occlusive Disease
Conditions
Keywords
Femoropopliteal Occlusive Disease, 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.
Interventions
PROCEDUREendovascular treatment
All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods according to the characteristics of the lesions. For example: (a) Plain old balloon angioplasty; (b) Drug-coated balloon angioplasty; (c) Drug-coated balloon angioplasty + provisional stenting; (d) Bare-metal stent implantation; (e) Stent graft implantation; (f) Directional atherectomy + drug-coated balloon angioplasty, (g) Drug -eluting stent.
Sponsors
RenJi Hospital
Xuanwu Hospital, Beijing
Second Affiliated Hospital of Suzhou University
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Chengdu University of Traditional Chinese Medicine
First Affiliated Hospital of Zhejiang University
Xiamen Cardiovascular Hospital, Xiamen University
Shanghai Zhongshan Hospital
Huashan Hospital
Qingdao Haici Hospital
First People's Hospital of Hangzhou
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 5. If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled 6. For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse events (MAE) | 24 months | major adverse events including major adverse limb events (MALE) or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | 7 days | Procedural success refers to 1. Establishment of continuous blood flow, no early occlusion, acute thrombosis or reintervention driven by target lesion within 7 days after operation |
| Clinical-driven Target lesion reintervention rate | 24 months | Target lesion reintervention rate |
| Incidence of major adverse limb events (MALE) | 24 months | Major adverse limb events (MALE) including clinically-driven target lesion revascularization (CD-TLR) and major amputation |
| Incidence of major amputation | 24 months | Major amputation defined as above-ankle amputation |
| All-cause mortality | 24 months | All-cause mortality defined as death from any cause |
Countries
China
Outcome results
None listed