The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation

NCT04713865 | Not Yet Recruiting

• 1 other identifier: the Sent-FP study
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Common Femoral Artery Occlusive Disease

Keywords

Common femoral artery occlusive disease; The bare metal stent; profound femoral artery patency

Outcome Measures

Primary Outcomes (1)

• Major adverse events and freedom from target lesion revascularization

  Major adverse events and freedom from target lesion revascularization at 48 months

  post-interventional 48 months

Secondary Outcomes (3)

• primary patency of PFA and bare metal stent

  post-interventional 1,6, 12,24,36 and 48 month

• MAE

  post-interventional 1,6, 12,24,36 month

• F -TLR

  post-interventional 1,6, 12,24,36 month

Study Arms (3)

PFA slightly jailed by proximal SFA stent(100 pts)

Procedure: endovascular treatment

PFA moderately jailed by proximal SFA stent(100 pts)

Procedure: endovascular treatment

PFA totally jailed by proximal SFA stent (100pts)

Procedure: endovascular treatment

Interventions

endovascular treatment PROCEDURE

The bare metal stent covers the deep femoral artery lower than 50%

PFA slightly jailed by proximal SFA stent(100 pts)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qingdao Hiser Medical Group: lead

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: August 18, 2021
• Primary Completion: August 17, 2023
• Study Completion (Estimated): August 17, 2026
• Last Updated: August 19, 2021

Record last verified: 2021-01