First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

Study Overview
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Brief Summary
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The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in the femoropopliteal arteries.

Detailed Description
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Endovascular treatment in femoropopliteal segment is the most challenging area due to restenosis and stent fracture after endovascular treatment. The titanium-nitride coated woven-nitinol peripheral arterial stent system (GoldenFlow, Lifetech Science, Shenzhen, China) is designed to have superior radial strength, flexibility and durability to withstand the compression, torsion, bending, lengthening and shortening found in femoropopliteal disease. Compared to another commercially available woven-nitinol stent, the GoldenFlow stent has the potential advantage to be repositionable and is less likely to lengthen during deployment. This is a first-in-man study is to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in de-novo femoropopliteal lesions.

Official Title
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First-in-man Study to Assess Efficacy and Safety of a Novel Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: GoldenFlow Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Symptomatic leg ischemia (Rutherford class 2 to 4) Ankle Brachial Index <0.9 De novo femoropopliteal stenosis (≥70%) or occlusion Reference diameter 4 and 7mm Lesion length 4 to 15cm At least one patent (<50% stenosis) infrapopliteal run-off vessel The lesion(s) can be successfully crossed with a guidewire and dilated Patients with bilateral femoropopliteal disease is eligible for enrollment into the study - Staged contralateral limb procedure can be performed >30 days after index procedure Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule Exclusion Criteria: Tissue loss or gangrene (Rutherford class 5 and 6) Previous bypass surgery or stenting in target vessel Untreated aortoiliac or common femoral artery inflow disease >50% Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GoldenFlow stent<br>Titanium nitrite coated woven nitinol stent | Device: GoldenFlow Stent<br>* The GoldenFlow stent (Lifetech Science, Shenzhen, China) is a TiN coated self-expanding stent consisting of interwoven nitinol wires braided in a closed cell design. Stents used in this study ranged from 4-12mm in diameter and 20-160mm in length.<br>* Other names: Titanium-nitride coated GoldenFlow woven-nitinol stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent binary restenosis of the treated segment | Determined by Duplex ultrasound | at 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | defined as residual diameter stenosis <30% | intraoperation | 
| Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization | Composite of death, index limb amputation and ischemic driven target vessel revacularization at 30 days | 30 days | 
| Clinically driven target vessel revascularization |  | 6 months | 
| Stent fracture | defined by plain x-ray | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoropopliteal disease, restenosis