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

Not Applicable

• Conditions: Peripheral Arterial Disease; Superficial Femoral Artery Stenosis; Superficial Femoral Artery Occlusion
• Interventions: Device: Drug eluting peripheral vascular stent system; Device: Nitinol Stent System

• Registration Number: NCT03121430
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2017-04-09
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-20
• Study Start: 2018-10-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18
• Primary Completion: 2020-07
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Drug eluting peripheral vascular stent system	subjects using the drug eluting peripheral vascular stent system
Group B	Nitinol Stent System	subjects using the Nitinol Stent System (Cordis Corporation)

Primary Outcome Measures

Name	Time	Method
primary patency rate at 12 months after operation	12 months	the rate of the target lesion diameter stenosis \<50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively

Secondary Outcome Measures

Name	Time	Method
primary patency rate at 6 months after operation	6 months	the rate of the target lesion diameter stenosis \<50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively
Stent fracture rate	6 months、12 months	using the Dual Fluoroscopic Imaging
target lesion revascularization rate	Preoperative，up to 1 month，6 months，12 months	subject found that the presence of restenosis in the target lesion in follow-up , and need to re-intervention or bypass graft according to the clinical symptoms

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China