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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Common Femoral Artery Occlusive Disease
• Intervention / Treatment: Procedure: endovascular treatment; Procedure: endovascular treatment; Procedure: endovascular treatment

• Study Type: Observational
• Enrollment (Anticipated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PFA slightly jailed by proximal SFA stent(100 pts)	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
PFA moderately jailed by proximal SFA stent(100 pts)	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
PFA totally jailed by proximal SFA stent (100pts)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary patency of PFA and bare metal stent	primary patency of PFA and bare metal stent at 1,6, 12,24,36 and 48 month	post-interventional 1,6, 12,24,36 and 48 month
MAE	Major adverse events at 1,6, 12,24,36 month	post-interventional 1,6, 12,24,36 month
F -TLR	freedom from target lesion revascularization at 1,6, 12,24,36 month	post-interventional 1,6, 12,24,36 month

Collaborators and Investigators

• Sponsor: Qingdao Hiser Medical Group

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 18, 2021
• Primary Completion (ANTICIPATED): August 17, 2023
• Study Completion (ANTICIPATED): August 17, 2026

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Common femoral artery occlusive disease; The bare metal stent; profound femoral artery patency
• Other Study ID Numbers: the Sent-FP study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No