Clinical trial NCT03121430: Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Superficial Femoral Artery Stenosis
Superficial Femoral Artery Occlusion
Keywords: peripheral arterial disease
Drug eluting peripheral vascular stent system
primary patency
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
First posted: 2017-04-20
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: primary patency rate at 12 months after operation
timeFrame: 12 months
Secondary outcomes:
measure: primary patency rate at 6 months after operation
timeFrame: 6 months
measure: target lesion revascularization rate
timeFrame: Preoperative，up to 1 month，6 months，12 months
measure: Stent fracture rate
timeFrame: 6 months、12 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
Study officials:
affiliation: Beijing Anzhen Hospital
name: Chen Zhong
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Guo Wei
role: PRINCIPAL_INVESTIGATOR
References: