Back to resultsTiming Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）
Primary Purpose
Carotid Artery Diseases, Carotid Artery Stenosis, Stroke
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Timing Carotid Stent
Carotid Wallstent
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Diseases
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
- 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
- Patient has a uncontrollable severe hyperemia
- Patient has a bradycardia
- mRS≥3
- Patient has life expectancy of less than one year
- Patient is currently enrolled in another investigational study protocol
- Females who are pregnant or in lactation
- Other conditions not suitable for inclusion judged by the researcher -
Sites / Locations
- Xuanwu HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Timing Carotid Stent
Carotid Wallstent
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Participants Who Achieved Stent Technical Success
Stent Technical Success defined as successful implantation of a Carotid Stent
Number of Participants Who Achieved Procedure Success
Number of Participants Who Achieved Procedure Success
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
In-Stent Restenosis
≥50% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation
Ipsilateral ischemic stroke
Any ipsilateral ischemic stroke through 1 year post-index procedure
mRS score change
mRS score change through 1 year post-index procedure
Full Information
NCT ID
NCT05574972
First Posted
October 7, 2022
Last Updated
January 3, 2023
Sponsor
Suzhou Zenith Vascular Scitech Co., Ltd.
Collaborators
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05574972
Brief Title
Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）
Official Title
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）
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zenith Vascular Scitech Co., Ltd.
Collaborators
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Diseases, Carotid Artery Stenosis, Stroke, Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Timing Carotid Stent
Arm Type
Experimental
Arm Title
Carotid Wallstent
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Timing Carotid Stent
Intervention Description
all the participants in this group will be performed with Timing Carotid Stent
Intervention Type
Device
Intervention Name(s)
Carotid Wallstent
Intervention Description
all the participants in this group will be performed with Carotid Wallstent
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days
Description
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved Stent Technical Success
Description
Stent Technical Success defined as successful implantation of a Carotid Stent
Time Frame
Procedural
Title
Number of Participants Who Achieved Procedure Success
Description
Number of Participants Who Achieved Procedure Success
Time Frame
Procedural
Title
Target Lesion Revascularization
Description
Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion
Time Frame
30 days
Title
In-Stent Restenosis
Description
≥50% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation
Time Frame
1 year
Title
Ipsilateral ischemic stroke
Description
Any ipsilateral ischemic stroke through 1 year post-index procedure
Time Frame
1 year
Title
mRS score change
Description
mRS score change through 1 year post-index procedure
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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
Patient has a uncontrollable severe hyperemia
Patient has a bradycardia
mRS≥3
Patient has life expectancy of less than one year
Patient is currently enrolled in another investigational study protocol
Females who are pregnant or in lactation
Other conditions not suitable for inclusion judged by the researcher -
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao
Phone
+8601083198277
Email
13911224991@139.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）
We'll reach out to this number within 24 hrs