Clinical trial NCT04713865: The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation
Official title: The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Common Femoral Artery Occlusive Disease
Keywords: Common femoral artery occlusive disease
The bare metal stent
profound femoral artery patency
Lead sponsor: Qingdao Hiser Medical Group
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 300
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: Patiens with De novo lesions located in the femoral artery bifurcation (5mm between distal CFA and proximal SFA), need for primary bare metal stent implantation

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 bifurcation lesions will be included and divided into 3 groups according to the location of proximal stent edge. The primary endpoint of the study is major adverse events and freedom from target lesion revascularization at 48 months. Secondary endpoints include primary patency of PFA and bare metal stent at 1,6, 12,24,36and 48 month, MAE and F -TLR at 1,6, 12,24,36 month.


Eligibility criteria: Inclusion Criteria:

1. Patients with chronic atherosclerosis obliterans aged over 18 years
2. Patients presenting Rutherford classification from 2-5
3. Patients is willing to follow-up on time
4. Patient has a life expectancy of at least 24 months
5. Prior to enrolment, the guidewire has crossed target lesion
6. De novo lesions located in the femoral artery bifurcation (5mm between distal CFA and proximal SFA), need for primary bare metal stent implantation
7. There is a patent deep femoral artery demonstrated by angiography
8. 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 Criteria:

1. Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc.
2. 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
3. Pregnant and lactating women
4. 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)
5. Patients with acute arterial thrombosis or embolism at the target lesion site.
6. 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

Primary outcomes:
measure: Major adverse events and freedom from target lesion revascularization
timeFrame: post-interventional 48 months
Secondary outcomes:
measure: primary patency of PFA and bare metal stent
timeFrame: post-interventional 1,6, 12,24,36 and 48 month
measure: MAE
timeFrame: post-interventional 1,6, 12,24,36 month
measure: F -TLR
timeFrame: post-interventional 1,6, 12,24,36 month
Other outcomes:
Locations:
Study officials:
References: