Carotid Artery StenosisNCT06864299

Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets

A study testing Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets in people with Carotid Artery Stenosis and Carotid Artery Diseases, run by Shenzhen Wecan Medical Technology Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carotid Artery Stenosis, Carotid Artery Diseases
What is being tested?: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteChina
Study dates: 1 Jun 2024to 1 Jun 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years;
Patients with internal carotid artery stenosis, meeting at least one of the following conditions:
Asymptomatic carotid artery stenosis: Stenosis severity > 70%;
Symptomatic carotid artery stenosis: Stenosis severity > 50%, with one or more of the following symptoms occurring within 180 days prior to the procedure: transient ischemic attack (TIA), transient visual obscurations (TVO), or mild/non-disabling stroke;
Common carotid artery diameter > 6 mm, and meets the required vascular diameter for carotid artery stenting;
The participant or their legal guardian is able to understand the purpose of the trial, voluntarily consent to participation, sign an informed consent form, and is willing to comply with follow-up requirements as outlined in the study protocol.

Who cannot join

Anatomical Exclusion Criteria:
Patients with extensive atherosclerotic plaques in the proximal common carotid artery, which hinder safe surgical manipulation;
Patients with lesions in the common carotid artery access area or its proximal segment;
Patients with the common carotid artery bifurcation located < 5 cm from the clavicular margin;
Patients with tandem severe stenosis or occlusion at the target lesion site;
Patients who have previously received stent or graft implantation in the ipsilateral carotid artery;

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Patients with bilateral carotid artery stenosis requiring intervention on both sides;
Patients with acute or subacute thrombosis, arteriovenous malformations, or other abnormal vascular structures in the target lesion or adjacent regions;
Patients with severe calcification or tortuosity at the target lesion site, making it difficult to deliver devices to the intended location;
Patients with concomitant severe symptomatic stenosis in other vascular territories, including intracranial or extracranial arteries;
Patients who have experienced an ischemic stroke within the past 3 months, which may impact endpoint evaluation;
Patients with a history of spontaneous intracranial hemorrhage within the past 12 months;
Patients diagnosed with carotid artery dissection;
Patients with carotid stenosis due to non-atherosclerotic causes;
Patients with other cardiovascular conditions that may predispose to embolism, including left ventricular aneurysm, cardiomyopathy, mechanical aortic or mitral valves, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma;
Patients with central nervous system disorders, including cranial nerve impairment, which could confound endpoint evaluation (e.g., severe dementia, secondary epilepsy, etc.);
Patients with chronic atrial fibrillation;
Patients with paroxysmal atrial fibrillation episodes within the past 6 months or those requiring long-term anticoagulation therapy due to paroxysmal atrial fibrillation;
Patients who have had a myocardial infarction within the last 6 months;
Patients who have undergone or plan to undergo coronary artery bypass grafting (CABG), endovascular stenting procedures, or heart valve surgeries within 90 days prior to the procedure, which may interfere with endpoint evaluation;
Patients with active bleeding tendencies or significant coagulation disorders;
Patients with a history of gastrointestinal bleeding that could interfere with antiplatelet therapy;
Patients with preoperative liver or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 5 times the upper limit of normal, or serum creatinine (Cr) > 3.0 mg/dL (265.2 μmol/L);
Patients with known hypersensitivity to contrast agents, anticoagulants, antiplatelet medications, or materials used in stent delivery systems (e.g., nitinol, PTFE, nylon-based polymers);
Patients with intracranial or other malignancies;
Patients with a life expectancy of less than 3 years;
Women who are planning pregnancy, pregnant, or breastfeeding;
Patients participating in another clinical trial or those who have not withdrawn or been excluded from a trial within the last 3 months of the screening period;
Other patients who, in the investigator's opinion, are deemed unsuitable for inclusion in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Anzhen Hospital, Capital Medical University
Beijing

Other trials in China

About this study

Official title: Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets for Cerebral Protection During Carotid Angioplasty

The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty

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

Conditions: Carotid Artery Stenosis, Carotid Artery Diseases
Being tested: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets
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 System Combined with Introducer SetsDevice
To evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty

Study groups in NCT06864299
Study group	Role	What they receive
Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets	Experimental	Device systems for the treatment of carotid artery stenosis Receives: Device: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets

What is being measured

The primary outcome is the main question the study is designed to answer.

The composite incidence of death, stroke, and myocardial infarction within 30 days postoperatively.
Composite incidence is the rate of occurrence of a composite endpoint, which is a combination of multiple study outcomes.
Measured: Within 30 days after procedure

Secondary outcomes (6)

Immediate technical success rate
Immediate technical success is defined as the complete proximal occlusion of the common carotid artery, successful establishment of an effective retrograde blood flow pathway, and the successful reconstruction of carotid blood circulation.
Measured: intraoperative
The incidence of stroke
The incidence of stroke refers to the occurrence of stroke within the follow-up time points, including hemorrhagic and ischemic strokes.
Measured: pre-discharge（up to 14 days）and 30 days post-surgery
The incidence of neurological injury
The incidence of neurological injury refers to the occurrence of neurological dysfunction within the follow-up time points, including assessment of swallowing disorders, voice disorders, and facial expression muscle impairment.
Measured: Within 24 hours post-surgery and 30 days post-surgery
The incidence of myocardial infarction
The incidence of myocardial infarction refers to deaths from any cause that occur within the follow-up time points.
Measured: pre-discharge（up to 14 days）and 30 days post-surgery
All-cause mortality during perioperative period (from surgery to 30 days after surgery)
All-cause mortality Refers to deaths from any cause that occur within the follow-up time points.
Measured: Intraoperatively, pre-discharge（up to 14 days）and 30 days post-surgery
Delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
Access-related complications refer to bleeding, rebleeding, and hematoma along the delivery access route. Hematomas include surgical wound hematoma, arterial access site hematoma, and femoral venous access site hematoma.
Measured: Intraoperatively, pre-discharge（up to 14 days）and 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20241 Jun 2025

First posted7 Mar 2025
Study start1 Jun 2024
Primary completion1 Jun 2025
Study completion1 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carotid Artery StenosisStudies 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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06864299
Sponsor's protocol ID: WKP002FIM(CN)-01
Status last verified: Mar 2025
First submitted: 3 Mar 2025
Last updated: 11 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Carotid Artery Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 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 Combined With Introducer Sets for Cerebral Protection During Carotid Angioplasty
ClinicalTrials.gov ID: NCT06864299
Acronym / sponsor ID: WKP002FIM(CN)-01
Conditions: Carotid Artery Stenosis, Carotid Artery Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Shenzhen Wecan Medical Technology Co.,LtdUniversity, hospital or other
Study start: 1 Jun 2024 (actual)
Primary completion: 1 Jun 2025 (actual)
Study completion: 1 Jun 2025 (actual)
First posted: 7 Mar 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 Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty

Detailed description

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 Combined with Introducer Sets	Experimental	Device: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer SetsDevice systems for the treatment of carotid artery stenosis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age ≥ 18 years;
Patients with internal carotid artery stenosis, meeting at least one of the following conditions:
Common carotid artery diameter > 6 mm, and meets the required vascular diameter for carotid artery stenting;
The participant or their legal guardian is able to understand the purpose of the trial, voluntarily consent to participation, sign an informed consent form, and is willing to comply with follow-up requirements as outlined in the study protocol.

Key exclusion criteria (29 listed)

Anatomical Exclusion Criteria:
Patients with concomitant severe symptomatic stenosis in other vascular territories, including intracranial or extracranial arteries;
Patients who have experienced an ischemic stroke within the past 3 months, which may impact endpoint evaluation;
Patients with a history of spontaneous intracranial hemorrhage within the past 12 months;
Patients diagnosed with carotid artery dissection;

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 System Combined with Introducer SetsTo evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty	Device	Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets

Primary outcome

The composite incidence of death, stroke, and myocardial infarction within 30 days postoperatively.
Time frame: Within 30 days after procedure
Composite incidence is the rate of occurrence of a composite endpoint, which is a combination of multiple study outcomes.

6 secondary outcomes

Immediate technical success rate
Time frame: intraoperative
The incidence of stroke
Time frame: pre-discharge（up to 14 days）and 30 days post-surgery
The incidence of neurological injury
Time frame: Within 24 hours post-surgery and 30 days post-surgery
The incidence of myocardial infarction
Time frame: pre-discharge（up to 14 days）and 30 days post-surgery
All-cause mortality during perioperative period (from surgery to 30 days after surgery)
Time frame: Intraoperatively, pre-discharge（up to 14 days）and 30 days post-surgery
Delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
Time frame: Intraoperatively, pre-discharge（up to 14 days）and 30 days post-surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Carotid Artery Stenosis

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

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.

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?

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 6 inclusion and 29 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: finished, as of the sponsor's last update on 11 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite incidence of death, stroke, and myocardial infarction within 30 days postoperatively. (time frame: Within 30 days after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864299.

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 11 Jul 2025.