A Prospective, Multi-center and Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Timing Carotid Stent for Carotid Artery Stenosis（Timing Trial）

Suzhou Zenith Vascular Scitech Co., Ltd.1 site in 1 country178 target enrollmentOctober 18, 2022

ConditionsCarotid Artery Diseases Carotid Artery Stenosis Stroke Ischemic Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carotid Artery Diseases
Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd.
Enrollment: 178
Locations: 1
Primary Endpoint: Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.

Detailed Description

This is a prospective, randomized, concurrent controlled, multi-center study. Patients with carotid artery stenosis will be assigned to either the Timing Carotid Stent or Carotid Wallstent. Each treated patient will be followed and assessed for 12 months after randomization. The hypothesis to be tested is that the safety and effectiveness of the Timing Carotid Stent is not inferior to the Carotid Wallstent.

Registry

clinicaltrials.gov

Start Date

October 18, 2022

End Date

May 30, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Zenith Vascular Scitech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18-85 years;
•Patient is either symptomatic with carotid stenosis ≥50% OR asymptomatic with carotid stenosis ≥70% ;
•Target lesion 3.5- 5.5 mm;
•Signed informed consent.

Exclusion Criteria

•Target lesion is not caused by atherosclerotic disease；
•Target lesion is located at the opening of the common carotid artery；
•Patient has severe lesion calcification that may restrict the full deployment of the carotid
•Patient has a total occlusion of the target carotid arteries
•Patient has a large number of acute or subacute thrombi and arteriovenous malformations near the target lesion
•Patient has a severe stenosis or occlusion in series with target lesions
•Patient has known severe carotid stenosis contralateral to the target lesion
•Patient need angioplasty in other parts (including intracranial and extracranial) at the same time or within 30 days after procedure
•Patient has a symptomatic severe stenosis of other blood vessels (including intracranial and extracranial) except carotid artery
•Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke or intracranial hemorrhage