The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endovascular treatment, endovascular treatment, endovascular treatment.
- Who it may be relevant to
- Registry conditions: Common Femoral Artery Occlusive Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure endovascular treatment
The bare metal stent covers the deep femoral artery lower than 50% - Procedure endovascular treatment
The bare metal stent covers the deep femoral artery in 50-90% - Procedure endovascular treatment
The bare metal stent totally covers the deep femoral artery
Primary outcome measures
- Major adverse events and freedom from target lesion revascularization [Time frame: post-interventional 48 months]
Secondary outcome measures (3)
- primary patency of PFA and bare metal stent [Time frame: post-interventional 1,6, 12,24,36 and 48 month]
- MAE [Time frame: post-interventional 1,6, 12,24,36 month]
- F -TLR [Time frame: post-interventional 1,6, 12,24,36 month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-crossover
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04713865 · the Sent-FP study