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Clinical Trials in China / NCT05894863
Recruiting Not applicable

Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions

NCT05894863 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Not applicable
Started
2023-05-31
Last updated
2023-06-08

Condition(s) studied

Peripheral Arterial Disease

Investigational drug(s) / intervention(s)

Smart flex stent

Smart flex stent: Smart flex stent will be used for femoropopliteal occlusive lesions.

Study summary

This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital Shanghai Shanghai Municipality Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05894863 on ClinicalTrials.gov ↗ ← All trials in China