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Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion

Peripheral Arterial Disease Clinical Trial

Official title:
The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial

Clinical Trial Summary

Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.

Clinical Trial Description

This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03121430
Study type Interventional
Source Zhejiang Zylox Medical Device Co., Ltd.
Contact Gao Feng
Phone +86 (0)10 8220-7036
Email md@osmundacn.com
Status Recruiting
Phase N/A
Start date October 22, 2018
Completion date February 2021
View Details
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