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Carotid Artery StenosisHeartCare CASNCT07370246

CAS for Stenosis With High-risk Features for CEA

A study testing Carotid artery stent system in people with Carotid Artery Stenosis and Carotid Artery Stenting, run by Beijing Tiantan Hospital at 16 sites 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
Search all trials

Trial summary

The purpose of this prospective, multicenter, single-group target-value study is to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carotid artery stent system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
16 sitesChina
Study dates
6 Mar 2026to 31 Dec 2028
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, male or female;
  • Pre-procedural carotid duplex ultrasound and/or computed tomography angiography confirmed stenosis of the common carotid artery, internal carotid artery, or carotid bifurcation, and are considered suitable for endovascular treatment;
  • Intra-procedural digital subtraction angiography, using NASCET criteria, confirmed stenosis of ≥ 50% (symptomatic) or ≥ 80% (asymptomatic), and symptomatic is defined as the occurrence of one or more clinical events within 6 months prior to the procedure, including transient ischemic attack, amaurosis fugax, or minor/non-disabling stroke attributable to the ipsilateral intracranial circulation;
  • The vessel diameter of the target lesion is between 3.0 mm and 9.0 mm;
  • Voluntary participation in this trial and provision of written informed consent.
  • Inclusion criteria for high-risk features for carotid endarterectomy:
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  • Comorbidity factors:
  • Age ≥ 75 years at the time of enrollment;
  • Patients with congestive heart failure (New York Heart Association Class III/IV);
  • Patients with unstable angina pectoris;
  • Patients with severe chronic obstructive pulmonary disease, defined as an FEV1 ≤ 50% of predicted, requirement for chronic oxygen therapy, or a resting PO₂ ≤ 60 mmHg;
  • Patients with left ventricular ejection fraction ≤ 30%;
  • Patients with recent myocardial infarction (within 2 to 6 weeks);
  • Patients with coronary artery disease with ≥ 70% stenosis in two or more major vessels;
  • Planned coronary artery bypass grafting or valve replacement surgery within 31 to 60 days following the procedure.
  • Anatomical factors:
  • Lesions located at or above the level of the second cervical vertebra (C2) or lesions that are surgically inaccessible below the clavicle;
  • History of radical head and neck surgery or radiotherapy;
  • Patients with limited cervical spine mobility;
  • Patients with tracheostomy;
  • History of vocal cord paralysis or laryngectomy;
  • Patients with contralateral recurrent laryngeal nerve palsy;
  • Patients with restenosis following previous carotid endarterectomy;
  • Patients with severe stenosis or occlusion of the contralateral carotid artery;
  • Severe tandem lesions that can be covered by a single stent.

Who cannot join

  • Target lesions caused by carotid arteritis;
  • Target lesions located at the origin of the common carotid artery;
  • Target lesions with extensive calcification or excessive tortuosity that preclude stent delivery;
  • Target lesions attributable to asymptomatic complete occlusion or the presence of a "string sign";
  • Target lesions adjacent to significant acute or subacute thrombus, or arteriovenous malformation;
  • History of major surgery (including intra-abdominal, intrathoracic, cardiac, or vascular procedures) within 30 days before the procedure, or any such surgery scheduled within 30 days after the procedure;
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  • History of intracranial hemorrhage or progressive stroke within 3 months before the procedure;
  • History of an extensive hemispheric stroke within 2 weeks before the procedure;
  • History of bradycardia (heart rate < 40 bpm) before the procedure;
  • History of paroxysmal atrial fibrillation within the past 6 months, or paroxysmal atrial fibrillation requiring long-term anticoagulation therapy;
  • Patients with known or potential sources of thromboembolism (including previously known symptomatic patent foramen ovale, mechanical heart valves, or deep vein thrombosis treated within 6 months);
  • Patients with a known intracranial aneurysm requiring surgical intervention that cannot be treated before the procedure;
  • Patients with known coagulation disorders (APTT > 3 times the upper limit of normal) or abnormal bleeding disorders;
  • Patients with known contraindications to heparin or antiplatelet agents;
  • Patients with a platelet count < 100×10^9/L;
  • Patients with known allergies to any components of the investigational product, contrast agents;
  • Patients with known severe hepatic or renal insufficiency (ALT or AST > 5 times the upper limit of normal, or serum creatinine > 3 times the upper limit of normal);
  • Patients with known uncontrolled severe hypertension (persistent systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg);
  • Patients with a pre-procedure mRS score > 3;
  • Patients with extensively metastatic malignancy;
  • Patients concurrently enrolled in another drug or medical device clinical trial;
  • Female patients who are currently pregnant or breastfeeding, or who plan to conceive within 1 year;
  • Lesions inaccessible by endovascular approach (including severe tortuosity of aortic arch branches with no suitable access artery, or special aortic arch anatomy);
  • According to the judgment of the investigator, patients with an expected survival of less than 12 months;
  • According to the judgment of the investigator, other situations that are not suitable for enrollment.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jiabao Yang, MD contact

+86 010-59978858

yangjiabao0773@163.com

16 sites in 1 country

China16 sites, 16 recruiting

  • Beijing Tiantan Hospital, Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100070

    Jiabao Yang, Dr., +86 010-59968858, yangjiabao0773@163.com

    Ning Ma, Pro.

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

    Baofeng Xu, Pro., +86 0431-81879901, xubf@jlu.edu.cn

    Baofeng Xu, Pro.

    Recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality

    Shengli Chen, Pro., +86 023-58103215, 2271487396@qq.com

    Shengli Chen, Pro.

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Gang Cai, Dr., +86 0851-86855119, caigang89@sina.com

    Zhang Yang, Pro.

    Recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Ziqi Xu, Pro., +86 057187236114, zyxuziqi@zju.cdu.cn

    Ziqi Xu, Pro.

    Recruiting

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia

    Rile Wu, Pro., +86 0471-3283999, wurile@hotmail.com

    Rile Wu, Pro.

    Recruiting

  • Jining First People's Hospital

    Jining, Shandong

    Jianfeng Chu, Pro., +86 0537-6056666, cjf18678769767@163.com

    Jianfeng Chu, Pro.

    Recruiting

  • Jiu Jiang No.1 People's Hospital

    Jiujiang, Jiangxi

    Hongbing Nie, Pro., +86 0792-8582052, niehongbin1@126.com

    Hongbing Nie, Pro.

    Recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang

    Xiao Peng, Pro., +86 0578-2285888, pengxiao2508@163.com

    Xiao Peng, Pro.

    Recruiting

  • The Second Nanning People's Hospital

    Nanning, Guangxi

    Tong Li, Pro., +86 0771-4881666, 416727438@qq.com

    Tong Li, Pro.

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Yong Zhang, Pro., +86 96166, bravezhang@126.com

    Yong Zhang, Pro.

    Recruiting

  • Hebei General Hospital

    Shijiazhuang, Hebei

    Guodong Xu, Pro., +86 85989696, xgd0606@163.com

    Guodong Xu, Pro.

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    En Wang, Pro., +86 0576-85120120, wange@enzemed.com

    En Wang, Pro.

    Recruiting

  • The Taizhou First People's Hospital

    Taizhou, Zhejiang

    Chenghua Xu, Pro., +86 057684120120, samuel5098@163.com

    Chenghua Xu, Pro.

    Recruiting

  • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

    Xiang Luo, Pro., +86 027-83663200, flydottjh@163.com

    Xiang Luo, Pro.

    Recruiting

  • Xingtai Central Hospital

    Xingtai, Hebei

    Yuqing Wei, Pro., +86 03192123010, xtyuqin@126.com

    Yuqing Wei, Pro.

    Recruiting

Other trials in China

About this study

Official title: Evaluating the Safety and Efficacy of the Carotid Artery Stenting System for Stenosis With High-risk Features for CEA: a Prospective, Multicenter, Single-group Target-value Study in China

The purpose of this prospective, multicenter, single-group target-value study is to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. This trial is utilizing the carotid artery stent system provided by Shanghai HeartCare Medical Technology Co., Ltd. and will be conducted at approximately 10 interventional neurology centers in China.

Read the detailed description

This trial is a prospective, multicenter, single-group target-value study to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. The primary outcome is a composite outcome that includes stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or ischemic stroke in the territory of the qualifying artery between day 31 and the end of the follow-up period.

Being tested
Carotid artery stent system
Keywords
Carotid artery stenosis, Carotid artery stent
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 stent systemDevice

    The carotid artery stent system consists of a nitinol self-expanding stent and a 1.65mm (5F) delivery device. At the tip of the delivery device and the inner part of the distal outer tube, there is a guidewire channel. The proximal end of the guidewire channel stops at the guidewire exchange port. The design allows for the accommodation of a guidewire with a diameter of 0.014inch (0.36mm).

Study groups in NCT07370246
Study groupRoleWhat they receive
Carotid artery stent systemExperimentalDevice: The carotid artery stent system, manufactured by Shanghai HeartCare Medical Technology Co., Ltd., is a self-expanding stent constructed from nitinol.
Receives: Device: Carotid artery stent system

What is being measured

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

  1. Stroke, myocardial infarction, and death within 30 days after the procedure, or stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure

    Stroke is defined as an event that causes focal neurological dysfunction or signs and lasts for at least 24 hours, including ischemic stroke and hemorrhagic stroke. Myocardial infarction is defined as an increase in creatine kinase isoenzyme (CK-MB) or troponin in the postoperative period that is at least twice the upper limit of the normal range, accompanied by ischemic symptoms such as chest pain, or the presence of ischemic electrocardiogram evidence. Ischemic stroke in the territory of the ipsilateral artery is defined as an ischemic stroke in the cerebral hemisphere that is supplied with blood flow by the target artery.

    Measured: 30 days after the procedure and 365 days after the procedure

Secondary outcomes (7)

  1. In-stent restenosis rate within 12 months after the procedure

    Angiography demonstrated restenosis of the target artery both within the 5-mm stent segment and at the stent margins, with a degree of stenosis ≥50%.

    Measured: 365 days after the procedure

  2. Implantation success rate

    Implantation success was defined as successful implantation of the stent (including delivery, release, and expansion), covering the target lesion area, and subsequent withdrawal of the delivery system.

    Measured: During the procedure

  3. Procedure success rate

    Procedure success is defined as successful stent implantation followed by angiographic confirmation of ≤30% residual stenosis at the target lesion and the absence of any major adverse event prior to hospital discharge.

    Measured: Before the discharge or 7 days after the procedure

  4. In-stent restenosis rate within 6 months after the procedure

    Angiography demonstrated restenosis of the target artery both within the 5-mm stent segment and at the stent margins, with a degree of stenosis ≥50%.

    Measured: 6 months after the procedure

  5. Symptomatic in-stent restenosis rate

    Symptomatic in-stent restenosis is defined as in-stent restenosis that results in an ischemic stroke or transient ischemic attack in the territory of the target artery.

    Measured: 6 months, and 12 months after the procedure

  6. Target lesion revascularization rate

    Target lesion revascularization is defined as any repeat revascularization procedure performed on the original treatment site, encompassing the initial lesion segment and a 5-mm border zone proximal and distal to it.

    Measured: 30 days, 6 months, and 12 months after the procedure

  7. Ischemic stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure

    Ischemic stroke is defined as a new focal neurological deficit of sudden onset that is associated with an infarction lesion on CT or MRI.

    Measured: 12 months after the procedure

Timeline

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

  1. First posted27 Jan 2026
  2. Study start6 Mar 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07370246
Sponsor's protocol ID
QX2025-015-01
Acronym
HeartCare CAS
Status last verified
Dec 2025
First submitted
26 Dec 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yang B, Ma Y, Wang T, Chen Y, Wang Y, Zhao Z, Chen D, Wang J, Xu X, Luo T, Hua Y, Ling F, Qureshi AI, Hong B, Jiao L; RECAS Trial Investigators. Carotid Endarterectomy and Stenting in a Chinese Population: Safety Outcome of the Revascularization of Extracranial Carotid Artery Stenosis Trial. Transl Stroke Res. 2021 Apr;12(2):239-247. doi: 10.1007/s12975-020-00835-8. Epub 2020 Jul 19.

    PubMed 32686047

  • Ronchey S, Praquin B, Orrico M, Serrao E, Ciceroni C, Alberti V, Fazzini S, Mangialardi N. Outcomes of 1000 Carotid Wallstent Implantations: Single-Center Experience. J Endovasc Ther. 2016 Apr;23(2):267-74. doi: 10.1177/1526602815626558. Epub 2016 Jan 23.

    PubMed 26802612

  • Hopkins LN, White CJ, Foster MT, Powell RJ, Zemel G, Diaz-Cartelle J. Carotid artery stenting and patient outcomes: the CABANA surveillance study. Catheter Cardiovasc Interv. 2014 Nov 15;84(6):997-1004. doi: 10.1002/ccd.25578. Epub 2014 Jul 18.

    PubMed 24948033

  • Iyer SS, White CJ, Hopkins LN, Katzen BT, Safian R, Wholey MH, Gray WA, Ciocca R, Bachinsky WB, Ansel G, Joye JD, Russell ME; BEACH Investigators. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J Am Coll Cardiol. 2008 Jan 29;51(4):427-34. doi: 10.1016/j.jacc.2007.09.045.

    PubMed 18222352

  • White CJ, Iyer SS, Hopkins LN, Katzen BT, Russell ME; BEACH Trial Investigators. Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results. Catheter Cardiovasc Interv. 2006 Apr;67(4):503-12. doi: 10.1002/ccd.20689.

    PubMed 16548004

  • Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Document Reviewers, Bellmunt-Montoya S, Bulbulia R, Darling RC 3rd, Eckstein HH, Giannoukas A, Koelemay MJW, Lindstrom D, Schermerhorn M, Stone DH. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):7-111. doi: 10.1016/j.ejvs.2022.04.011. Epub 2022 May 20. No abstract available.

    PubMed 35598721

Questions about this trial

What is this clinical trial studying?

A study testing Carotid artery stent system in people with Carotid Artery Stenosis and Carotid Artery Stenting, run by Beijing Tiantan Hospital at 16 sites 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 25 inclusion and 25 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 Jiabao Yang, MD (+86 010-59978858, yangjiabao0773@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke, myocardial infarction, and death within 30 days after the procedure, or stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure (time frame: 30 days after the procedure and 365 days after the 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 NCT07370246, which also lists 6 linked publications.

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 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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