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

• Sponsor: Qingdao Hiser Medical Group (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04713865
• Collaborator: (none)
• Enrollment: 300
• Anticipated Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Femoral Artery Occlusive Disease	Procedure: endovascular treatment; Procedure: endovascular treatment; Procedure: endovascular treatment

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation
• Anticipated Study Start Date: Aug 18, 2021
• Anticipated Primary Completion Date: Aug 17, 2023
• Anticipated Study Completion Date: Aug 17, 2026

Arms and Interventions

Arm	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%
PFA moderately jailed by proximal SFA stent(100 pts)	Procedure: endovascular treatment; The bare metal stent covers the deep femoral artery in 50-90%
PFA totally jailed by proximal SFA stent (100pts)	Procedure: endovascular treatment; The bare metal stent totally covers the deep femoral artery

Outcome Measures

Primary Outcome Measures

1. Major adverse events and freedom from target lesion revascularization [post-interventional 48 months]

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

Secondary Outcome Measures

1. primary patency of PFA and bare metal stent [post-interventional 1,6, 12,24,36 and 48 month]

   primary patency of PFA and bare metal stent at 1,6, 12,24,36 and 48 month

2. MAE [post-interventional 1,6, 12,24,36 month]

   Major adverse events at 1,6, 12,24,36 month

3. F -TLR [post-interventional 1,6, 12,24,36 month]

   freedom from target lesion revascularization at 1,6, 12,24,36 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Qingdao Hiser Medical Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qingdao Hiser Medical Group
• ClinicalTrials.gov Identifier: NCT04713865
• Other Study ID Numbers: the Sent-FP study
• First Posted: Jan 19, 2021
• Last Update Posted: Aug 19, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qingdao Hiser Medical Group: Common femoral artery occlusive disease; The bare metal stent; profound femoral artery patency

Study Results

No Results Posted as of Aug 19, 2021