CAS for Stenosis With High-risk Features for CEA

NCT07370246 | Recruiting

• 1 other identifier: QX2025-015-01
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 16

Brief 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. 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.

Conditions

Carotid Artery Stenting; Carotid Artery Stenosis

Keywords

Carotid artery stenosis; Carotid artery stent

Outcome Measures

Primary Outcomes (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.

  30 days after the procedure and 365 days after the procedure

Secondary Outcomes (7)

• In-stent restenosis rate within 12 months after the procedure

  365 days after the procedure

• Implantation success rate

  During the procedure

• Procedure success rate

  Before the discharge or 7 days after the procedure

• In-stent restenosis rate within 6 months after the procedure

  6 months after the procedure

• Symptomatic in-stent restenosis rate

  6 months, and 12 months after the procedure

Other Outcomes (3)

• Major adverse event rate

  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

Study Arms (1)

Carotid artery stent system

EXPERIMENTAL

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

Interventions

Carotid artery stent system DEVICE

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).

Carotid artery stent system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Shanghai HeartCare Medical Technology Co., Ltd.: collaborator

Study Sites (16)

Beijing Tiantan Hospital, Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The Second Nanning People's Hospital

Nanning, Guangxi, China

RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, China

RECRUITING

Xingtai Central Hospital

Xingtai, Hebei, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

RECRUITING

Jiu Jiang No.1 People's Hospital

Jiujiang, Jiangxi, China

RECRUITING

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Jining First People's Hospital

Jining, Shandong, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

RECRUITING

The Taizhou First People's Hospital

Taizhou, Zhejiang, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 32686047 RESULT

• 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.

  PMID: 26802612 RESULT

• 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.

  PMID: 24948033 RESULT

• 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.

  PMID: 18222352 RESULT

• 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.

  PMID: 16548004 RESULT

• 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.

  PMID: 35598721 RESULT

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ning Ma, Professor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiabao Yang, MD

CONTACT

+86 010-59978858; yangjiabao0773@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 27, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2025-12

Locations

CN (16)