Clinical trial NCT06365697: Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis
Official title: Efficacy and Safety of the Ton-bridge Carotid Stent for the Treatment of Carotid Artery Stenosis: a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carotid Artery Stenosis
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-15
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis.

Detailed description: This is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial carried out in 7 research centers in China. Patients with carotid atherosclerotic stenosis will be randomized (1:1) to either the Ton-bridge carotid stent or WALLSTENT carotid stent for treatment. The purpose of this clinical trial is to evaluate the effectiveness and safety of a novel carotid stent, the Ton-bridge carotid stent, in humans for treatment.

Eligibility criteria: Inclusion Criteria:

* Patient is 18-80 years old and of any sex;
* Patient is diagnosed with carotid atherosclerotic stenosis by imaging. The lesion site is located in the extracranial segment of carotid artery and is suitable for endovascular treatment. Patient is either symptomatic with carotid stenosis≥50% or asymptomatic with carotid stenosis≥70% as determined by digital subtraction angiography (DSA) using NASCET methodology.

  * Symptomatic is defined as non-disabling ischemic stroke (mRS≤2) or transient cerebral ischemia (TIA, including cerebral hemispheric neurological events and amaurosis fugax) associated with the carotid stenosis within the past 6 months.
* The target vessel reference diameter ranges from 3.5mm to 9mm.
* Patient has been informed of the nature of this trial, understood the purpose of this clinical investigation, and volunteered to participate and sign the informed consent form.

Exclusion Criteria:

* Evolving stroke within 3 months before index procedure, disabling stroke (mRS≥3) before the procedure, or massive cerebral infarction (area of infarction is \>1/3 of the ipsilateral middle cerebral artery territory) within 30 days before the procedure.
* Myocardial infarction within 30 days prior to index procedure.
* Severe heart, lung, liver, or renal insufficiency.
* Patient has known bleeding diathesis, or contraindication to heparin or antiplatelet therapy.
* Patient has a known allergy to contrast media or nickel-titanium material.
* Disturbance of consciousness, dementia, or severe neurological deficits (NIHSS≥15 or mRS≥3)
* Severe hypertension (Systolic blood pressure≥180mmHg and/or diastolic blood pressure≥110mmHg) difficult to be controlled.
* Patient has known risk factors for embolization.
* Patient has had any major surgical procedure (i.e., intraabdominal or intrathoracic surgery, any surgery or interventional procedure involving cardiac, cerebral or vascular system) within 30 days before index procedure.
* Patient has had any intracranial surgery or intracranial hemorrhage within 1 year before index procedure.
* Patient has other known neurological diseases such as intracranial tumor, which may confound the neurological assessments.
* Intracranial aneurysm or arteriovenous malformation, which requires treatment.
* Patient has other known vascular lesion requiring intervention at the same time or within 30 days after index procedure.
* Patient has other carotid diseases such as vasculitis, carotid dissection, carotid aneurysm and fibromuscular dysplasia.
* Ipsilateral intracranial artery severe stenosis (≥70%), occlusion or dissection; stenosis(≥50%) or occlusion of ipsilateral common carotid artery opening or brachiocephalic artery; any previously placed stent in the ipsilateral carotid artery or brachiocephalic artery; the target lesion is a restenosis after a previous carotid endarterectomy (CEA).
* The target lesion vessel has intraluminal filling defect, thrombosis, occlusion or subtotal occlusion ("string sign").
* Severe tortuous anatomy or other anatomic factors that prohibit the safe placement of the catheter or stent systems.
* Pregnant or lactating female.
* Patient is participating in an investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation.
* Other circumstances which the investigator considers unsuitable for participating in this investigation.

Primary outcomes:
measure: Incidence of non-MAE(major adverse events) within 30 days post-procedure
timeFrame: Up to 30 days
Secondary outcomes:
measure: Technical success
timeFrame: Intraprocedure
measure: Procedural success
timeFrame: before discharge or up to 7 days
measure: Target lesion revascularization (TLR) rate
timeFrame: Up to 1 year
measure: Ipsilateral stroke between 31 days and 1 year post-procedure
timeFrame: Between 31 days and 1 year
measure: In-stent restenosis rate
timeFrame: 180±30 days, 360±30 days
measure: mRS score
timeFrame: 30±7 days, 180±30 days, 360±30 days
measure: Device deficiency
timeFrame: Up to 1 year
measure: Incidence of MAE
timeFrame: Up to 1 year
measure: Incidence of Adverse events (AE)
timeFrame: Up to 1 year
measure: Incidence of Serious adverse events (SAE)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Jinan
country: China
facility: Central Hospital Affiliated to Shangdong First Medical University
state: Shangdong
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Central Hospital Affiliated to Shangdong First Medical University
name: Liqun Jiao
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Yong Zhang
role: PRINCIPAL_INVESTIGATOR
References: