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

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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Superficial Femoral Artery Occlusion; Superficial Femoral Artery Stenosis
• Intervention / Treatment: Device: Drug eluting peripheral vascular stent system; Device: Nitinol Stent System

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • Recruiting
    • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; subjects using the drug eluting peripheral vascular stent system	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）
ACTIVE_COMPARATOR: Group B; subjects using the Nitinol Stent System (Cordis Corporation)	Device: Nitinol Stent System; Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）; Other Names: Cordis Corporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Stent fracture rate	using the Dual Fluoroscopic Imaging	6 months、12 months

Collaborators and Investigators

• Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
• Collaborators: Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
• Investigators: Principal Investigator: Chen Zhong, Beijing Anzhen Hospital; Principal Investigator: Guo Wei, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2018
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (ACTUAL): April 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: peripheral arterial disease; Drug eluting peripheral vascular stent system; primary patency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Pathological Conditions, Anatomical; Peripheral Arterial Disease; Peripheral Vascular Diseases; Constriction, Pathologic
• Other Study ID Numbers: 2052108140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No