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)
Primary patency — 12-month Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
Freedom of major adverse events (MAEs) — 12-month Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
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.
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