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Safety and Efficacy Study of GoldenFlow Peripheral Stent System

Femoral Artery Occlusion Clinical Trial

Official title:
Safety and Efficacy Study of GoldenFlow Peripheral Stent System, A Prospective, Multi-center, Single-Arm Clinical Trial

Clinical Trial Summary

A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lower limb artery stenosis or occlusion diseases.

Clinical Trial Description

A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lower limb artery stenosis or occlusion diseases. A total of 90 cases of patients, who are suitable to be treated with Peripheral Stent will be screened and enrolled according to the inclusion and exclusion criteria, and the lesion will be treated with GodenFlow Peripheral Stent System under the guidance of Digital Subtraction Angiography (DSA). Clinical and imaging follow-up was conducted 3 months and 6 months after surgery, The follow-ups mainly included clinical symptoms and signs, ankle-brachial index (ABI) and colour Doppler ultrasound, Computed Tomography Angiography (CTA), etc., for the sake of verifying the efficacy and safety of the device in treating patients with lower limb artery stenosis or occlusion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03687983
Study type Interventional
Source Lifetech Scientific (Shenzhen) Co., Ltd.
Contact Ying Xia
Phone +86 13760184511
Email xiaying@lifetechmed.com
Status Recruiting
Phase N/A
Start date May 11, 2016
Completion date December 2019
View Details
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