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Carotid Artery StenosisNCT06959628

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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
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 Jul 2024to 1 Jun 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;
  • 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. Contact the study team or a site near you to ask about taking part.

zhong chen, Professor contact

18911662898

chenzhong86580@vip.sina.com

China1 site, 1 recruiting

  • Beijing Anzhen Hospital

    Beijing

    zhong chen, Professor, 18911662898, chenzhong86580@vip.sina.com

    Recruiting

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

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 NCT06959628
Study groupRoleWhat they receive
Trans-Carotid Artery Occlusion Shunt System Combined with Introducer SetsExperimentalDevice 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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. First posted6 May 2025
  2. Study start1 Jul 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959628
Sponsor's protocol ID
WKP002FIM(CN)-01
Status last verified
Apr 2025
First submitted
28 Apr 2025
Last updated
6 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

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.

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: looking for participants now, as of the sponsor's last update on 6 May 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 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 NCT06959628.

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 6 May 2025.

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