An interventional study of GoldenFlow Stent in Peripheral Arterial Disease, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 5 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Patients with bilateral femoropopliteal disease is eligible for enrollment into the study
Exclusion Criteria:
Titanium nitrite coated woven nitinol stent
Device: GoldenFlow 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.
Also known as: Titanium-nitride coated GoldenFlow woven-nitinol stent
In-stent binary restenosis of the treated segment
Determined by Duplex ultrasound
Time frame: at 6 month
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
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong