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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03121430
Other study ID # 2052108140
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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