Peripheral Arterial Disease
Conditions
Keywords
femoropopliteal disease, restenosis
Brief summary
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
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.
Interventions
DEVICEGoldenFlow Stent
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.
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent binary restenosis of the treated segment | at 6 month | Determined by Duplex ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | intraoperation | defined as residual diameter stenosis \<30% |
| Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization | 30 days | Composite of death, index limb amputation and ischemic driven target vessel revacularization at 30 days |
| Clinically driven target vessel revascularization | 6 months | — |
| Stent fracture | 6 months | defined by plain x-ray |
Countries
Hong Kong
Outcome results
None listed