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

Chinese University of Hong Kong5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

GoldenFlow StentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years 2. Symptomatic leg ischemia (Rutherford class 2 to 4) 3. Ankle Brachial Index \<0.9 4. De novo femoropopliteal stenosis (≥70%) or occlusion 5. Reference diameter 4 and 7mm 6. Lesion length 4 to 15cm 7. At least one patent (\<50% stenosis) infrapopliteal run-off vessel 8. The lesion(s) can be successfully crossed with a guidewire and dilated 9. Patients with bilateral femoropopliteal disease is eligible for enrollment into the study \- Staged contralateral limb procedure can be performed \>30 days after index procedure 10. Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule Exclusion Criteria: 1. Tissue loss or gangrene (Rutherford class 5 and 6) 2. Previous bypass surgery or stenting in target vessel 3. Untreated aortoiliac or common femoral artery inflow disease \>50% 4. Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure

Locations (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Outcomes

Primary Outcomes

In-stent binary restenosis of the treated segment

Determined by Duplex ultrasound

Time frame: at 6 month

Secondary Outcomes

Technical Success

defined as residual diameter stenosis \<30%

Time frame: 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

Time frame: 30 days

Clinically driven target vessel revascularization

Time frame: 6 months

Stent fracture

defined by plain x-ray

Time frame: 6 months

Data from ClinicalTrials.gov

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