RevascularizationNCT06924593
Study on the Trans-Carotid Artery Occlusion Shunt System
A study testing Trans-Carotid Artery Occlusion Shunt System in people with Revascularization and Carotid Artery Stenosis, run by Shenzhen Wecan Medical Technology Co.,Ltd at 1 site in China.
Trial summary
The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revascularization, Carotid Artery Stenosis, Carotid Artery Diseases
- What is being tested?
- Trans-Carotid Artery Occlusion Shunt System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years;
- For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met:
- Symptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be > 50%, and the patient has a history of stroke (mild or non-disabling), transient ischemic attack (TIA), and/or amaurosis fugax within 180 days before the operation.
- Asymptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be > 70%, and the patient has not experienced any neurological symptoms within 180 days before the operation.
- The modified Rankin Scale (mRs) score ≤ 2 before enrollment.
- The patient must meet at least one of the following important anatomical or comorbid high-risk conditions in order to be included in the study:
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- Anatomical high-risk:
- Contralateral carotid artery occlusion; B. Presence of tandem stenosis in the internal carotid artery with a stenosis degree > 70%; C. Carotid artery stenosis above the C2 vertebral body; D. Restenosis after previous ipsilateral carotid endarterectomy; E. Bilateral carotid artery stenosis requiring treatment (treatment of the contralateral vessel should be carried out at least 30 days after the operation); F. "Difficult neck" suitable for the transcarotid approach as evaluated by the researcher, including but not limited to: history of previous neck radiotherapy, history of previous radical neck lymph node dissection, neck stoma or limited cervical spine mobility.
- Comorbid high-risk:
- The patient's age is ≥ 70 years old; H. The patient has coronary artery disease involving > 2 vessels and has a history of angina pectoris of any severity; I. The patient has a history of angina pectoris, with Canadian Cardiovascular Society (CCS) angina class 3 or 4, or unstable angina pectoris (defined as resting angina pectoris accompanied by electrocardiogram changes); J. The patient has congestive heart failure (CHF) - New York Heart Association (NYHA) functional class 3 or 4; K. The patient is known to have severe left ventricular dysfunction with a left ventricular ejection fraction (LVEF) < 30%; L. The patient has experienced a myocardial infarction within 72 hours to 6 weeks before the operation; M. The patient has severe pulmonary disease (chronic obstructive pulmonary disease, COPD), with a forced expiratory volume in one second (FEV1) < 50% (predicted value), or has been receiving long-term oxygen therapy, or has an arterial partial pressure of oxygen (PO2) ≤ 60 mmHg (room air) at rest; N. The patient has permanent contralateral cranial nerve injury; O. The patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).
- The diameter of the common carotid artery on the target lesion side is > 6 mm;
- The patient is able to understand the purpose of the trial, voluntarily participates in this study, signs the informed consent form, and is willing to complete the follow-up according to the requirements of the protocol.
Who cannot join
- Anatomical exclusion criteria:
- There are extensive atherosclerotic plaques in the proximal part of the common carotid artery on the target lesion side, making the safe operation of the surgery difficult; There are lesions in the access area of the common carotid artery on the target lesion side and its proximal part towards the heart; The distance from the superior border of the clavicle on the target lesion side to the bifurcation of the common carotid artery is less than 5 cm; A stent or graft has been implanted in the carotid artery on the target lesion side; There are acute or subacute thrombosis, arteriovenous malformations at the target lesion or adjacent areas; Severe calcification or tortuosity at the target lesion site makes it difficult to deliver the instruments to the designated location; The target carotid artery is completely occluded;
- Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);
- Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);
- The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;
- There has been spontaneous intracranial hemorrhage within 12 months;
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- Carotid artery stenosis not caused by atherosclerosis (such as dissection, fibromuscular dysplasia, etc.);
- There are other heart diseases that may lead to embolism: such as left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, artificial aortic valve or artificial mitral valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm or left atrial myxoma, etc.;
- Severe dementia or other nervous system diseases that may interfere with the evaluation of neurological function;
- Advanced heart failure;
- Chronic atrial fibrillation; Paroxysmal atrial fibrillation with an episode within 6 months or paroxysmal atrial fibrillation requiring long-term anticoagulant therapy;
- Myocardial infarction occurred within 72 hours before the operation;
- Coronary artery bypass grafting (CABG), endovascular stent surgery, cardiac valve surgery or vascular surgical procedures have been or will be performed within 30 days before and after the operation;
- There is an active bleeding tendency or severe coagulation dysfunction; There has been gastrointestinal bleeding within 30 days before the operation, which will affect antiplatelet therapy;
- Hemoglobin (Hgb) < 8 gm/dL, platelet count < 90×10^9/L or a history of heparin-induced thrombocytopenia;
- Patients with abnormal liver and kidney function before the operation [Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Serum creatinine (Cr) > 3.0mg/dL (265.2μmol/L) or end-stage renal disease receiving hemodialysis];
- Patients known to be allergic to contrast agents, stent and delivery device materials (referring to nitinol, PTFE, nylon polymer materials); Patients known to have contraindications to anticoagulant and antiplatelet drugs;
- Intracranial tumors or other malignant tumors;
- Life expectancy is less than 1 year;
- Women who plan to become pregnant, are pregnant or are breastfeeding;
- Patients who are participating in other clinical trials at the same time and have not withdrawn from the trials;
- Patients who are judged by the researcher as not suitable for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
zhong chen, Professor
About this study
Official title: Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization During Endovascular Treatment
The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment
Read the detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
- Being tested
- Trans-Carotid Artery Occlusion Shunt System
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-Carotid Artery Occlusion Shunt SystemDevice
To evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment
| Study group | Role | What they receive |
|---|---|---|
| Trans-Carotid Artery Occlusion Shunt System | Experimental | Device systems for Carotid Artery Revascularization during Endovascular Treatment Receives: Device: Trans-Carotid Artery Occlusion Shunt System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite incidence rate of death, stroke, and myocardial infarction within 30 days after the operation.
The composite incidence rate of death, stroke, and myocardial infarction.
Measured: 30 days after the operation
Secondary outcomes (10)
Immediate technical success rate
Immediate technical success is defined as complete occlusion of the proximal common carotid artery, effectively establishing a blood flow reversal circulation pathway, and successfully withdrawing the device.
Measured: Immediate technical success rate
Surgical success rate
Surgical success is defined as technical success without major adverse events (MAE is defined as death, stroke, or myocardial infarction).
Measured: 30 days after the operation
Incidence rate of stroke within 30 days after the operation
The researcher will confirm whether the subject has suffered a stroke.
Measured: 30 days after the operation
Incidence rate of cranial nerve injury within 30 days after the operation
The researcher will confirm whether the subject has suffered a cranial nerve injury.
Measured: 30 days after the operation
Incidence rate of myocardial infarction within 30 days after the operation
The researcher will confirm whether the subject has suffered a myocardial infarction.
Measured: 30 days after the operation
All-cause mortality rate within 30 days after the operation
All-cause mortality refers to deaths from any cause that occur within the follow-up time points.
Measured: 30 days after the operation
Incidence rate of access complications within 30 days after the operation
Access complications refer to various adverse situations or complications that occur during or after the establishment of vascular accesses.
Measured: 30 days after the operation
Incidence rate of ipsilateral stroke within 30 days after the operation
The researcher will confirm whether the subject has suffered a ipsilateral stroke.
Measured: 30 days after the operation
Device-related adverse events
Adverse events refer to adverse medical events that occur during the process of a clinical trial, regardless of whether they are related to the medical device used in the trial. However, normal postoperative stress responses should be distinguished, such as fever, discomfort in the chest and back, etc. If, upon the judgment of the researcher, it is determined to be a normal postoperative stress response, there is no need to record it as an adverse event of the medical device. Adverse events related to the medical device refer to situations that are determined by the researcher to be definitely related, possibly related, or undeterminable in relation to the medical device used in the trial.
Measured: Before discharge (up to 14 days), 30 days after the operation
Incidence rate of serious adverse events
Serious adverse events refer to events that occur during the clinical trial process and lead to death or a serious deterioration of health status, including fatal diseases or injuries, permanent defects in body structure or body function, the need for hospitalization or an extended hospital stay, the need to take medical measures to avoid permanent defects in body structure or body function, and events that lead to fetal distress, fetal death, or congenital abnormalities and congenital defects.
Measured: Before discharge (up to 14 days), 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start30 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RevascularizationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Wecan Medical Technology Co.,Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhong chen, Professor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924593
- Sponsor's protocol ID
- WKP002CT(CN)-01
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization During Endovascular Treatment
- ClinicalTrials.gov ID
- NCT06924593
- Acronym / sponsor ID
- WKP002CT(CN)-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Shenzhen Wecan Medical Technology Co.,LtdUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Apr 2025 (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.
The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment
Detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-Carotid Artery Occlusion Shunt System | Experimental | Device: Trans-Carotid Artery Occlusion Shunt SystemDevice systems for Carotid Artery Revascularization during Endovascular Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18 years;
- For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met:
- The modified Rankin Scale (mRs) score ≤ 2 before enrollment.
- The patient must meet at least one of the following important anatomical or comorbid high-risk conditions in order to be included in the study:
- Contralateral carotid artery occlusion; B. Presence of tandem stenosis in the internal carotid artery with a stenosis degree > 70%; C. Carotid artery stenosis above the C2 vertebral body; D. Restenosis after previous ipsilateral carotid endarterectomy; E. Bilateral carotid artery stenosis requiring treatment (treatment of the contralateral vessel should be carried out at least 30 days after the operation); F. "Difficult neck" suitable for the transcarotid approach as evaluated by the researcher, including but not limited to: history of previous neck radiotherapy, history of previous radical neck lymph node dissection, neck stoma or limited cervical spine mobility.
Key exclusion criteria (22 listed)
- Anatomical exclusion criteria:
- There are extensive atherosclerotic plaques in the proximal part of the common carotid artery on the target lesion side, making the safe operation of the surgery difficult; There are lesions in the access area of the common carotid artery on the target lesion side and its proximal part towards the heart; The distance from the superior border of the clavicle on the target lesion side to the bifurcation of the common carotid artery is less than 5 cm; A stent or graft has been implanted in the carotid artery on the target lesion side; There are acute or subacute thrombosis, arteriovenous malformations at the target lesion or adjacent areas; Severe calcification or tortuosity at the target lesion site makes it difficult to deliver the instruments to the designated location; The target carotid artery is completely occluded;
- Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);
- Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);
- The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;
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 |
|---|---|---|
| Trans-Carotid Artery Occlusion Shunt SystemTo evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment | Device | Trans-Carotid Artery Occlusion Shunt System |
Primary outcome
The composite incidence rate of death, stroke, and myocardial infarction within 30 days after the operation.
Time frame: 30 days after the operation
The composite incidence rate of death, stroke, and myocardial infarction.
10 secondary outcomes
Immediate technical success rate
Time frame: Immediate technical success rate
Surgical success rate
Time frame: 30 days after the operation
Incidence rate of stroke within 30 days after the operation
Time frame: 30 days after the operation
Incidence rate of cranial nerve injury within 30 days after the operation
Time frame: 30 days after the operation
Incidence rate of myocardial infarction within 30 days after the operation
Time frame: 30 days after the operation
All-cause mortality rate within 30 days after the operation
Time frame: 30 days after the operation
Incidence rate of access complications within 30 days after the operation
Time frame: 30 days after the operation
Incidence rate of ipsilateral stroke within 30 days after the operation
Time frame: 30 days after the operation
Device-related adverse events
Time frame: Before discharge (up to 14 days), 30 days after the operation
Incidence rate of serious adverse events
Time frame: Before discharge (up to 14 days), 30 days after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- 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.
zhong chen, Professor principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-Carotid Artery Occlusion Shunt System in people with Revascularization and Carotid Artery Stenosis, run by Shenzhen Wecan Medical Technology Co.,Ltd 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 12 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhong chen, Professor (18911662898, chenzhong86580@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite incidence rate of death, stroke, and myocardial infarction within 30 days after the operation. (time frame: 30 days after the operation). 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 7 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.