CAS for Stenosis With High-risk Features for CEA

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

Overview

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.

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.

Interventions

• 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).

Primary outcome measures

• 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]

Secondary outcome measures (7)

• In-stent restenosis rate within 12 months after the procedure [Time frame: 365 days after the procedure]
• Implantation success rate [Time frame: During the procedure]
• Procedure success rate [Time frame: 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]
• Symptomatic in-stent restenosis rate [Time frame: 6 months, and 12 months after the procedure]
• Target lesion revascularization rate [Time frame: 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]

Eligibility criteria

Inclusion criteria

• 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:

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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 16 centers

• Beijing Tiantan Hospital, Affiliated to Capital Medical University — Beijing
• Chongqing University Three Gorges Hospital — Chongqing
• The Second Nanning People's Hospital — Nanning
• The Affiliated Hospital of Guizhou Medical University — Guiyang
• Hebei General Hospital — Shijiazhuang
• Xingtai Central Hospital — Xingtai
• Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science an — Wuhan
• Inner Mongolia Autonomous Region People's Hospital — Hohhot
• … and 8 more centers

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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, Doc PMID 35598721

Identifiers

NCT: NCT07370246 · QX2025-015-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗