Carotid Artery DiseasesNCT05574972
Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）
A study testing Timing Carotid Stent and Carotid Wallstent in people with Carotid Artery Diseases and Carotid Artery Stenosis, run by Suzhou Zenith Vascular SciTech Limited at 1 site in China.
Trial summary
Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Diseases, Carotid Artery Stenosis, Stroke
- What is being tested?
- Timing Carotid Stent and Carotid Wallstent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing
Liqun Jiao, +8601083198277, 13911224991@139.com
About this study
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）
Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.
Read the 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.
- Being tested
- Timing Carotid Stent, Carotid Wallstent
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis, Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing Carotid StentDevice
all the participants in this group will be performed with Timing Carotid Stent
Carotid WallstentDevice
all the participants in this group will be performed with Carotid Wallstent
| Study group | Role | What they receive |
|---|---|---|
| Timing Carotid Stent | Experimental | Not described Receives: Device: Timing Carotid Stent |
| Carotid Wallstent | Active comparator | Not described Receives: Device: Carotid Wallstent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (6)
Number of Participants Who Achieved Stent Technical Success
Stent Technical Success defined as successful implantation of a Carotid Stent
Measured: Procedural
Number of Participants Who Achieved Procedure Success
Number of Participants Who Achieved Procedure Success
Measured: 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
Measured: 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
Measured: 1 year
Ipsilateral ischemic stroke
Any ipsilateral ischemic stroke through 1 year post-index procedure
Measured: 1 year
mRS score change
mRS score change through 1 year post-index procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start18 Oct 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zenith Vascular SciTech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574972
- Sponsor's protocol ID
- ZTYL202201
- Status last verified
- Jan 2023
- First submitted
- 7 Oct 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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）
- ClinicalTrials.gov ID
- NCT05574972
- Acronym / sponsor ID
- ZTYL202201
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Suzhou Zenith Vascular SciTech LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timing Carotid Stent | Experimental | Device: Timing Carotid Stent |
| Carotid Wallstent | Active comparator | Device: Carotid Wallstent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing Carotid Stentall the participants in this group will be performed with Timing Carotid Stent | Device | Timing Carotid Stent |
| Carotid Wallstentall the participants in this group will be performed with Carotid Wallstent | Device | Carotid Wallstent |
Primary outcome
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
6 secondary outcomes
Number of Participants Who Achieved Stent Technical Success
Time frame: Procedural
Number of Participants Who Achieved Procedure Success
Time frame: Procedural
Target Lesion Revascularization
Time frame: 30 days
In-Stent Restenosis
Time frame: 1 year
Ipsilateral ischemic stroke
Time frame: 1 year
mRS score change
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing Carotid Stent and Carotid Wallstent in people with Carotid Artery Diseases and Carotid Artery Stenosis, run by Suzhou Zenith Vascular SciTech Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.