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

Zhejiang Zylox Medical Device

Status: Unknown

Conditions: Superficial Femoral Artery Occlusion; Superficial Femoral Artery Stenosis; Peripheral Arterial Disease

Treatments: Device: Drug eluting peripheral vascular stent system; Device: Nitinol Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03121430

2052108140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Group A

Experimental group

Description:

subjects using the drug eluting peripheral vascular stent system

Treatment:

Device: Drug eluting peripheral vascular stent system

Group B

Active Comparator group

Description:

subjects using the Nitinol Stent System (Cordis Corporation)

Treatment:

Device: Nitinol Stent System