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

NCT ID: NCT04713865

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2026-08-17

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

PFA slightly jailed by proximal SFA stent(100 pts)

endovascular treatment

Intervention Type: PROCEDURE

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

PFA moderately jailed by proximal SFA stent(100 pts)

endovascular treatment

Intervention Type: PROCEDURE

The bare metal stent covers the deep femoral artery in 50-90%

PFA totally jailed by proximal SFA stent (100pts)

endovascular treatment

Intervention Type: PROCEDURE

The bare metal stent totally covers the deep femoral artery

Interventions

endovascular treatment

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

Intervention Type: PROCEDURE

endovascular treatment

The bare metal stent covers the deep femoral artery in 50-90%

Intervention Type: PROCEDURE

endovascular treatment

The bare metal stent totally covers the deep femoral artery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qingdao Hiser Medical Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

the Sent-FP study

Identifier Type: -

Identifier Source: org_study_id