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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03121430
• Other study ID #: 2052108140
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: February 2021

Study information

• Verified date: February 2019
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: Gao Feng
• Phone: +86 (0)10 8220-7036
• Email: md[@]osmundacn.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: February 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria in Preoperative:

• Aged from 18 to 85 years old, male or female

• Subject's target lesions were stenosis and/or occlusion

• Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent

Exclusion Criteria in Preoperative:

• In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration

• Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration

• Subject with coagulation abnormalities should not be performed

Related Conditions & MeSH terms

• Constriction, Pathologic
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Superficial Femoral Artery Occlusion
• Superficial Femoral Artery Stenosis

Intervention

Device:
• Drug eluting peripheral vascular stent system
Drug eluting peripheral vascular stent system?Color Doppler Ultrasonography (CDU) imaging?Dual Fluoroscopic Imaging?Digital subtraction angiography(DSA)
• Nitinol Stent System
Nitinol Stent System?Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging?Digital subtraction angiography(DSA)

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.	Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary patency rate at 12 months after operation	the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively	12 months
Secondary	primary patency rate at 6 months after operation	the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively	6 months
Secondary	target lesion revascularization rate	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	Preoperative,up to 1 month,6 months,12 months
Secondary	Stent fracture rate	using the Dual Fluoroscopic Imaging	6 months?12 months