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

NCT05574972 | Unknown DMC

• 1 other identifier: ZTYL202201
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Artery Diseases; Carotid Artery Stenosis; Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Participants Who Achieved Stent Technical Success

  Procedural

• Number of Participants Who Achieved Procedure Success

  Procedural

• Target Lesion Revascularization

  30 days

• In-Stent Restenosis

  1 year

• Ipsilateral ischemic stroke

  1 year

Study Arms (2)

Timing Carotid Stent

EXPERIMENTAL

Device: Timing Carotid Stent

Carotid Wallstent

ACTIVE COMPARATOR

Device: Carotid Wallstent

Interventions

Timing Carotid Stent DEVICE

all the participants in this group will be performed with Timing Carotid Stent

Timing Carotid Stent

Carotid Wallstent DEVICE

all the participants in this group will be performed with Carotid Wallstent

Carotid Wallstent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patient has a massive stroke or myocardial infarction
• Patient has a intracranial aneurysm
• Patient has a coagulation dysfunction or abnormal bleeding, or contraindications to heparin and antiplatelet drugs
• Patient has known sensitivity to contrast agent
• 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

Sponsors & Collaborators

• Suzhou Zenith Vascular Scitech Co., Ltd.: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

Xuanwu Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis; Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: October 18, 2022
• Primary Completion: December 30, 2024
• Study Completion: May 30, 2025
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)