Status:
NOT_YET_RECRUITING
The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation
Lead Sponsor:
Qingdao Hiser Medical Group
Conditions:
Common Femoral Artery Occlusive Disease
Eligibility:
All Genders
18+ years
Brief Summary
The stent-FP study investigates the impact of coverage of profound femoral artery (PFA) by bare metal stent deployed in proximal superficial femoral artery (SFA) lesions. 300 patients with femoral bif...
Eligibility Criteria
Inclusion
- Patients with chronic atherosclerosis obliterans aged over 18 years
- Patients presenting Rutherford classification from 2-5
- Patients is willing to follow-up on time
- Patient has a life expectancy of at least 24 months
- Prior to enrolment, the guidewire has crossed target lesion
- De novo lesions located in the femoral artery bifurcation (5mm between distal CFA and proximal SFA), need for primary bare metal stent implantation
- There is a patent deep femoral artery demonstrated by angiography
- If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled （9）For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery .
- (10) 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 (11) Informed consent signed by patients
Exclusion
- Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc.
- In the past 3 months, they have participated in other drugs that interfere with this clinical trial or patients in clinical trials of medical devices
- Pregnant and lactating women
- Patients with other diseases that may make the trial difficult or significantly shorten the patient's life expectancy (\<2 years), such as tumors, severe liver disease, cardiac insufficiency, etc or patients whose life expectancy is less than 24 months (24 months of follow-up are required)
- Patients with acute arterial thrombosis or embolism at the target lesion site.
- Patients who underwent stent implantation in common femoral artery previously
- (8) Use of thrombectomy, atherectomy or laser devices during procedure (9) Previous open surgery in the same limb . (10) Patients with deep femoral artery totally occlusion
Key Trial Info
Start Date :
August 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 17 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04713865
Start Date
August 18 2021
End Date
August 17 2026
Last Update
August 19 2021
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