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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02499510
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Completed
Phase N/A
Start date October 2015
Completion date May 2018
View Details
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