Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）

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）

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Ischemic Stroke; Carotid Artery Diseases; Carotid Artery Stenosis
• Intervention / Treatment: Device: Timing Carotid Stent; Device: Carotid Wallstent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital
    • Contact: Liqun Jiao; Phone Number: +8601083198277; Email: 13911224991@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Target lesion is not caused by atherosclerotic disease；
2. Target lesion is located at the opening of the common carotid artery；
3. Patient has severe lesion calcification that may restrict the full deployment of the carotid
4. Patient has a total occlusion of the target carotid arteries
5. Patient has a large number of acute or subacute thrombi and arteriovenous malformations near the target lesion
6. Patient has a severe stenosis or occlusion in series with target lesions
7. Patient has known severe carotid stenosis contralateral to the target lesion
8. Patient need angioplasty in other parts (including intracranial and extracranial) at the same time or within 30 days after procedure
9. Patient has a symptomatic severe stenosis of other blood vessels (including intracranial and extracranial) except carotid artery
10. Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke or intracranial hemorrhage
11. Patient has a massive stroke or myocardial infarction
12. Patient has a intracranial aneurysm
13. Patient has a coagulation dysfunction or abnormal bleeding, or contraindications to heparin and antiplatelet drugs
14. Patient has known sensitivity to contrast agent
15. Patient has a platelet < 90 × 109 / L, severe liver and kidney injury, and severe dysfunction of important organs such as heart, lung, liver and kidney
16. Patient has a uncontrollable severe hyperemia
17. Patient has a bradycardia
18. mRS≥3
19. Patient has life expectancy of less than one year
20. Patient is currently enrolled in another investigational study protocol
21. Females who are pregnant or in lactation
22. Other conditions not suitable for inclusion judged by the researcher -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Timing Carotid Stent	Device: Timing Carotid Stent; all the participants in this group will be performed with Timing Carotid Stent
Active Comparator: Carotid Wallstent	Device: Carotid Wallstent; all the participants in this group will be performed with Carotid Wallstent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days	MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Stent Technical Success	Stent Technical Success defined as successful implantation of a Carotid Stent	Procedural
Number of Participants Who Achieved Procedure Success	Number of Participants Who Achieved Procedure Success	Procedural
Target Lesion Revascularization	Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion	30 days
In-Stent Restenosis	≥50% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation	1 year
Ipsilateral ischemic stroke	Any ipsilateral ischemic stroke through 1 year post-index procedure	1 year
mRS score change	mRS score change through 1 year post-index procedure	1 year

Collaborators and Investigators

• Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd.
• Collaborators: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Stroke; Ischemic Stroke; Carotid Stenosis; Carotid Artery Diseases; Constriction, Pathologic
• Other Study ID Numbers: ZTYL202201

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