Carotid Artery PlaqueCASTLENCT05524207
Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque
An observational study of Carotid Artery Plaque and Carotid Stenosis, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
To investigate the efficacy and safety of carotid stenting for vulnerable carotid plaques. All patients with carotid artery stenosis underwent carotid arterial contrast-enhanced ultrasonography before operation. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Carotid Artery Plaque, Carotid Stenosis, Stent Embolisation
- What is being tested?
- carotid artery stenting
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients suffering from carotid artery stenosis
Who may be able to join
- The patients with ischemic symptom whose carotid stenosis were more than 50%
- The patients without ischemic symptom whose carotid stenosis were more than 70%
Who cannot join
- • Confirmed with severe intracranial vascular lesions
- Suffering from the large area cerebral infarction or critical stroke sequela
- Restenosis after CEA or CAS
- Suffering from severe coronary heart disease, respiratory failure,the hypertension difficult to controled
- Patients with malignant tumor or expected life < 2 years
Trial locations and contacts
1 site in 1 country.
weiwei wu, M.D. contact
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing
keqiang zhao, M.D., 0086-56118899, zkqiang@139.com
About this study
Official title: A Controlled Clinical Study of Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque
To investigate the efficacy and safety of carotid stenting for vulnerable carotid plaques. All patients with carotid artery stenosis underwent carotid arterial contrast-enhanced ultrasonography before operation. According to the examination results, they were divided into two groups: vulnerable plaque group and stable plaque group. The incidence of perioperative stroke events in the two groups was compared. The incidence of stroke events in the two groups within 1 year was compared.
Read the detailed description
- To enroll 100 cases of patients suffering from carotid artery stenosis。the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues
- The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection.
- All patients undergo carotid stent. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.
- Conditions
- Carotid Artery Plaque, Carotid Stenosis, Stent Embolisation
- Being tested
- carotid artery stenting
- Keywords
- carotid artery stenosis, vulnerable plague, carotid stenting
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid artery stentingProcedure or surgery
Implantation of stents at the site of carotid artery stenosis for the treatment of carotid plaque with severe stenosis
| Study group | Role | What they receive |
|---|---|---|
| Vulnerable plaque group | Patients with preoperative contrast-enhanced intra-plaque contrast agent were classified as vulnerable plaque group Receives: Procedure: carotid artery stenting | |
| Stable plaque group | The patients with no contrast agent enhancement in the plaque showed preoperative contrast-enhanced ultrasound were classified as stable plaque group Receives: Procedure: carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative 30-day stroke rate
To determine whether there is a new cerebral infarction by postoperative re-examination of brain MRI and preoperative brain MRI
Measured: 30 days
Secondary outcomes (1)
1-year stroke rate after surgery
Stroke rate in ipsilateral carotid artery blood supply area within 1 year after operation
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 posted1 Sep 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keqiang Zhao, Beijing Tsinghua Chang Gung Hospital
- Investigators
- sifan yang, Study director, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524207
- Sponsor's protocol ID
- 20220816
- Acronym
- CASTLE
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 1 Sep 2022
- 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 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Study of Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque
- ClinicalTrials.gov ID
- NCT05524207
- Acronym / sponsor ID
- CASTLE / 20220816
- Conditions
- Carotid Artery Plaque, Carotid Stenosis, Stent Embolisation
- Keywords
- carotid artery stenosis, vulnerable plague, carotid stenting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Sep 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.
To investigate the efficacy and safety of carotid stenting for vulnerable carotid plaques. All patients with carotid artery stenosis underwent carotid arterial contrast-enhanced ultrasonography before operation. According to the examination results, they were divided into two groups: vulnerable plaque group and stable plaque group. The incidence of perioperative stroke events in the two groups was compared. The incidence of stroke events in the two groups within 1 year was compared.
Detailed description
- To enroll 100 cases of patients suffering from carotid artery stenosis。the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues
- The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection.
- All patients undergo carotid stent. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vulnerable plaque group | – | Procedure: carotid artery stentingPatients with preoperative contrast-enhanced intra-plaque contrast agent were classified as vulnerable plaque group |
| Stable plaque group | – | Procedure: carotid artery stentingThe patients with no contrast agent enhancement in the plaque showed preoperative contrast-enhanced ultrasound were classified as stable plaque group |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients suffering from carotid artery stenosis
Key inclusion criteria (2 listed)
- The patients with ischemic symptom whose carotid stenosis were more than 50%
- The patients without ischemic symptom whose carotid stenosis were more than 70%
Key exclusion criteria (5 listed)
- • Confirmed with severe intracranial vascular lesions
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 |
|---|---|---|
| carotid artery stentingImplantation of stents at the site of carotid artery stenosis for the treatment of carotid plaque with severe stenosis | Procedure or surgery | Stable plaque group, Vulnerable plaque group |
Primary outcome
Perioperative 30-day stroke rate
Time frame: 30 days
To determine whether there is a new cerebral infarction by postoperative re-examination of brain MRI and preoperative brain MRI
1 secondary outcome
1-year stroke rate after surgery
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 1 Sep 2022.
- 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.
weiwei wu, M.D. contact
sifan yang study director
Beijing Tsinghua Chang Gung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Plaque and Carotid Stenosis, run by Beijing Tsinghua Chang Gung Hospital 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 2 inclusion and 5 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 1 Sep 2022. 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?
Contact keqiang zhao, M.D. (0086-56119121, zkqiang@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative 30-day stroke rate (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 1 Sep 2022.