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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- Recruiting
- Xuanwu Hospital
-
Contact:
- Liqun Jiao
- Phone Number: +8601083198277
- Email: 13911224991@139.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Timing Carotid Stent
|
all the participants in this group will be performed with Timing Carotid Stent
|
|
Active Comparator: Carotid Wallstent
|
all the participants in this group will be performed with Carotid Wallstent
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days
Time Frame: 30 days
|
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure
|
30 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Achieved Stent Technical Success
Time Frame: Procedural
|
Stent Technical Success defined as successful implantation of a Carotid Stent
|
Procedural
|
|
Number of Participants Who Achieved Procedure Success
Time Frame: Procedural
|
Number of Participants Who Achieved Procedure Success
|
Procedural
|
|
Target Lesion Revascularization
Time Frame: 30 days
|
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
Time Frame: 1 year
|
≥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
Time Frame: 1 year
|
Any ipsilateral ischemic stroke through 1 year post-index procedure
|
1 year
|
|
mRS score change
Time Frame: 1 year
|
mRS score change through 1 year post-index procedure
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ZTYL202201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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