NCT05894863 Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
| NCT ID | NCT05894863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2026-01-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-05-31 with a primary completion date of 2026-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
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
Contact & Investigator
Meng Ye, M.D.
PRINCIPAL INVESTIGATOR
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Frequently Asked Questions
Who can join the NCT05894863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05894863 currently recruiting?
Yes, NCT05894863 is actively recruiting participants. Contact the research team at niqihong1989@163.com for enrollment information.
Where is the NCT05894863 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05894863 clinical trial?
NCT05894863 is sponsored by RenJi Hospital. The principal investigator is Meng Ye, M.D. at Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University. The trial plans to enroll 120 participants.