Using Smart Flex Stent to Treat Long Femoropopliteal Artery Lesions

Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study

This study is testing if the Smart Flex Stent can safely help people with Peripheral Arterial Disease who have long blockages in their leg arteries feel better and improve their blood flow.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05894863 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of the Smart Flex Stent System in treating long femoropopliteal artery lesions in patients with Peripheral Arterial Disease. It will include 120 patients with lesions longer than 15 cm, who will be followed up at 1, 6, 12, and 24 months post-procedure. The primary focus is on achieving primary patency at 12 months and ensuring freedom from major adverse events during the same period. Secondary endpoints will assess various success rates and quality of life changes over the follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with Rutherford classification scores of 2 to 5 and specific angiographic criteria.

Not a fit: Patients with previous bypass surgery or stenting in the target vessel or those with acute thrombus at the target lesion will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow and reduce complications for patients with long femoropopliteal artery lesions.

How similar studies have performed: Other studies have shown promising results with similar stent systems, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. The patient presented a score from 2 to 5 following Rutherford classification
2. The patient is willing to comply with specified follow-up evaluations at the specified times
3. The patient is \>18 years old
4. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
5. The patient has a projected life expectancy of at least 24 months
6. Before enrolment, the guidewire has crossed the target lesion
7. Target lesion length ≧150mm by angiographic estimation
8. Stenosis \> 50% or occlusion in the femoropopliteal artery
9. There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot

Exclusion Criteria:

1. Previous bypass surgery or stenting in the target vessel
2. Patients who exhibit acute intraluminal thrombus at the target lesion vessel
3. Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
4. Pregnant women or Female patients with potential childbearing
5. Use of thrombectomy, atherectomy, or laser devices during the procedure
6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
7. The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
8. Significant renal dysfunction (Serum creatinine \>2.0mg/dl)
9. Patient with Known allergy to contrast media

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Meng Ye, M.D. — Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
• Study coordinator: Ni Qihong, M.D.

Conditions Peripheral Arterial Disease; Femoropopliteal lesions; Patency