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

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: Recruiting
• Conditions: Carotid Artery Stenting; Carotid Artery Stenosis
• Intervention / Treatment: Device: Carotid artery stent system

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: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiabao Yang, MD; Phone Number: +86 010-59978858; Email: yangjiabao0773@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Affiliated to Capital Medical University
      • Contact: Jiabao Yang, Dr.; Phone Number: +86 010-59968858; Email: yangjiabao0773@163.com
      • Principal Investigator: Ning Ma, Pro.
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Recruiting
      • Chongqing University Three Gorges Hospital
      • Contact: Shengli Chen, Pro.; Phone Number: +86 023-58103215; Email: 2271487396@qq.com
      • Principal Investigator: Shengli Chen, Pro.
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • The Second Nanning People's Hospital
      • Contact: Tong Li, Pro.; Phone Number: +86 0771-4881666; Email: 416727438@qq.com
      • Principal Investigator: Tong Li, Pro.
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • The Affiliated Hospital of Guizhou Medical University
      • Contact: Gang Cai, Dr.; Phone Number: +86 0851-86855119; Email: caigang89@sina.com
      • Principal Investigator: Zhang Yang, Pro.
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • Hebei General Hospital
      • Contact: Guodong Xu, Pro.; Phone Number: +86 85989696; Email: xgd0606@163.com
      • Principal Investigator: Guodong Xu, Pro.
    • Xingtai, Hebei, China
      • Recruiting
      • Xingtai central hospital
      • Contact: Yuqing Wei, Pro.; Phone Number: +86 03192123010; Email: xtyuqin@126.com
      • 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: Xiang Luo, Pro.; Phone Number: +86 027-83663200; Email: flydottjh@163.com
      • Principal Investigator: Xiang Luo, Pro.
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • Recruiting
      • Inner Mongolia Autonomous Region People's Hospital
      • Contact: Rile Wu, Pro.; Phone Number: +86 0471-3283999; Email: wurile@hotmail.com
      • Principal Investigator: Rile Wu, Pro.
  • Jiangxi
    • Jiujiang, Jiangxi, China
      • Recruiting
      • Jiu Jiang NO.1 People's Hospital
      • Contact: Hongbing Nie, Pro.; Phone Number: +86 0792-8582052; Email: niehongbin1@126.com
      • Principal Investigator: Hongbing Nie, Pro.
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Bethune Hospital of Jilin University
      • Contact: Baofeng Xu, Pro.; Phone Number: +86 0431-81879901; Email: xubf@jlu.edu.cn
      • Principal Investigator: Baofeng Xu, Pro.
  • Shandong
    • Jining, Shandong, China
      • Recruiting
      • Jining First People's Hospital
      • Contact: Jianfeng Chu, Pro.; Phone Number: +86 0537-6056666; Email: cjf18678769767@163.com
      • Principal Investigator: Jianfeng Chu, Pro.
    • Qingdao, Shandong, China
      • Recruiting
      • The affiliated hospital of Qingdao university
      • Contact: Yong Zhang, Pro.; Phone Number: +86 96166; Email: bravezhang@126.com
      • Principal Investigator: Yong Zhang, Pro.
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Ziqi Xu, Pro.; Phone Number: +86 057187236114; Email: zyxuziqi@zju.cdu.cn
      • Principal Investigator: Ziqi Xu, Pro.
    • Lishui, Zhejiang, China
      • Recruiting
      • Lishui Central Hospital
      • Contact: Xiao Peng, Pro.; Phone Number: +86 0578-2285888; Email: pengxiao2508@163.com
      • Principal Investigator: Xiao Peng, Pro.
    • Taizhou, Zhejiang, China
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: En Wang, Pro.; Phone Number: +86 0576-85120120; Email: wange@enzemed.com
      • Principal Investigator: En Wang, Pro.
    • Taizhou, Zhejiang, China
      • Recruiting
      • The Taizhou First People's Hospital
      • Contact: Chenghua Xu, Pro.; Phone Number: +86 057684120120; Email: samuel5098@163.com
      • Principal Investigator: Chenghua Xu, Pro.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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	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

Outcome Measure	Measure Description	Time Frame
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%.	365 days after the procedure
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.	During the procedure
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.	Before the discharge or 7 days after the procedure
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%.	6 months after the procedure
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.	6 months, and 12 months after the procedure
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.	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	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

Outcome Measure	Measure Description	Time Frame
Major adverse event rate	Major adverse events are defined as all deaths, strokes, and myocardial infarctions.	30 days, 6 months, 12 months after the procedure
Adverse events rate		30 days, 6 months, and 12 months after the procedure
Serious adverse events rate		30 days, 6 months, and 12 months after the procedure

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Shanghai HeartCare Medical Technology Co., Ltd.
• Investigators: Principal Investigator: Ning Ma, Professor, Beijing Tiantan Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Carotid artery stenosis; Carotid artery stent
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID 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