CAS for Stenosis With High-risk Features for CEA (HeartCare CAS)

April 13, 2026 updated by: Beijing Tiantan Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Affiliated to Capital Medical University
        • Contact:
        • Principal Investigator:
          • Ning Ma, Pro.
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing University Three Gorges Hospital
        • Contact:
        • Principal Investigator:
          • Shengli Chen, Pro.
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The Second Nanning People's Hospital
        • Contact:
        • Principal Investigator:
          • Tong Li, Pro.
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
        • Principal Investigator:
          • Zhang Yang, Pro.
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei General Hospital
        • Contact:
        • Principal Investigator:
          • Guodong Xu, Pro.
      • Xingtai, Hebei, China
        • Recruiting
        • Xingtai Central Hospital
        • Contact:
        • Principal Investigator:
          • Yuqing Wei, Pro.
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Xiang Luo, Pro.
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Inner Mongolia Autonomous Region People's Hospital
        • Contact:
        • Principal Investigator:
          • Rile Wu, Pro.
    • Jiangxi
      • Jiujiang, Jiangxi, China
        • Recruiting
        • Jiu Jiang NO.1 People's Hospital
        • Contact:
        • Principal Investigator:
          • Hongbing Nie, Pro.
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Baofeng Xu, Pro.
    • Shandong
      • Jining, Shandong, China
        • Recruiting
        • Jining First People's Hospital
        • Contact:
        • Principal Investigator:
          • Jianfeng Chu, Pro.
      • Qingdao, Shandong, China
        • Recruiting
        • The Affiliated Hospital Of Qingdao University
        • Contact:
        • Principal Investigator:
          • Yong Zhang, Pro.
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contact:
        • Principal Investigator:
          • Ziqi Xu, Pro.
      • Lishui, Zhejiang, China
        • Recruiting
        • Lishui Central Hospital
        • Contact:
        • Principal Investigator:
          • Xiao Peng, Pro.
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
        • Principal Investigator:
          • En Wang, Pro.
      • Taizhou, Zhejiang, China
        • Recruiting
        • The Taizhou First People's Hospital
        • Contact:
        • Principal Investigator:
          • Chenghua Xu, Pro.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years, male or female;
  2. 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;
  3. 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;
  4. The vessel diameter of the target lesion is between 3.0 mm and 9.0 mm;
  5. Voluntary participation in this trial and provision of written informed consent.

Inclusion criteria for high-risk features for carotid endarterectomy:

Comorbidity factors:

  1. Age ≥ 75 years at the time of enrollment;
  2. Patients with congestive heart failure (New York Heart Association Class III/IV);
  3. Patients with unstable angina pectoris;
  4. 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;
  5. Patients with left ventricular ejection fraction ≤ 30%;
  6. Patients with recent myocardial infarction (within 2 to 6 weeks);
  7. Patients with coronary artery disease with ≥ 70% stenosis in two or more major vessels;
  8. Planned coronary artery bypass grafting or valve replacement surgery within 31 to 60 days following the procedure.

Anatomical factors:

  1. Lesions located at or above the level of the second cervical vertebra (C2) or lesions that are surgically inaccessible below the clavicle;
  2. History of radical head and neck surgery or radiotherapy;
  3. Patients with limited cervical spine mobility;
  4. Patients with tracheostomy;
  5. History of vocal cord paralysis or laryngectomy;
  6. Patients with contralateral recurrent laryngeal nerve palsy;
  7. Patients with restenosis following previous carotid endarterectomy;
  8. Patients with severe stenosis or occlusion of the contralateral carotid artery;
  9. Severe tandem lesions that can be covered by a single stent.

Exclusion Criteria:

  1. Target lesions caused by carotid arteritis;
  2. Target lesions located at the origin of the common carotid artery;
  3. Target lesions with extensive calcification or excessive tortuosity that preclude stent delivery;
  4. Target lesions attributable to asymptomatic complete occlusion or the presence of a "string sign";
  5. Target lesions adjacent to significant acute or subacute thrombus, or arteriovenous malformation;
  6. 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;
  7. History of intracranial hemorrhage or progressive stroke within 3 months before the procedure;
  8. History of an extensive hemispheric stroke within 2 weeks before the procedure;
  9. History of bradycardia (heart rate < 40 bpm) before the procedure;
  10. History of paroxysmal atrial fibrillation within the past 6 months, or paroxysmal atrial fibrillation requiring long-term anticoagulation therapy;
  11. 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);
  12. Patients with a known intracranial aneurysm requiring surgical intervention that cannot be treated before the procedure;
  13. Patients with known coagulation disorders (APTT > 3 times the upper limit of normal) or abnormal bleeding disorders;
  14. Patients with known contraindications to heparin or antiplatelet agents;
  15. Patients with a platelet count < 100×10^9/L;
  16. Patients with known allergies to any components of the investigational product, contrast agents;
  17. 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);
  18. Patients with known uncontrolled severe hypertension (persistent systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg);
  19. Patients with a pre-procedure mRS score > 3;
  20. Patients with extensively metastatic malignancy;
  21. Patients concurrently enrolled in another drug or medical device clinical trial;
  22. Female patients who are currently pregnant or breastfeeding, or who plan to conceive within 1 year;
  23. Lesions inaccessible by endovascular approach (including severe tortuosity of aortic arch branches with no suitable access artery, or special aortic arch anatomy);
  24. According to the judgment of the investigator, patients with an expected survival of less than 12 months;
  25. According to the judgment of the investigator, other situations that are not suitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Carotid artery stent system
Device: The carotid artery stent system, manufactured by Shanghai HeartCare Medical Technology Co., Ltd., is a self-expanding stent constructed from nitinol.
Device: Carotid artery stent system
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
30 days after the procedure and 365 days after the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-stent restenosis rate within 12 months after the procedure
Time Frame: 365 days 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%.
365 days after the procedure
Implantation success rate
Time Frame: During the procedure
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.
During the procedure
Procedure success rate
Time Frame: Before the discharge or 7 days after the procedure
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.
Before the discharge or 7 days after the procedure
In-stent restenosis rate within 6 months after the procedure
Time Frame: 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%.
6 months after the procedure
Symptomatic in-stent restenosis rate
Time Frame: 6 months, and 12 months after the procedure
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.
6 months, and 12 months after the procedure
Target lesion revascularization rate
Time Frame: 30 days, 6 months, and 12 months after the procedure
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.
30 days, 6 months, and 12 months after the procedure
Ischemic stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure
Time Frame: 12 months 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.
12 months after the procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse event rate
Time Frame: 30 days, 6 months, 12 months after the procedure
Major adverse events are defined as all deaths, strokes, and myocardial infarctions.
30 days, 6 months, 12 months after the procedure
Adverse events rate
Time Frame: 30 days, 6 months, and 12 months after the procedure
30 days, 6 months, and 12 months after the procedure
Serious adverse events rate
Time Frame: 30 days, 6 months, and 12 months after the procedure
30 days, 6 months, and 12 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai HeartCare Medical Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ning Ma, Professor, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QX2025-015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings