Single-Arm Trial of Carotid Stenting for Carotid Stenosis (Timing Trial)

A Prospective, Multicenter, Single-arm, Target Value Clinical Trial to Evaluate the Efficacy and Safety of the Carotid Artery Stent System in the Treatment of Carotid Artery Stenosis

This is a prospective, multicenter, single-group, target value clinical trial planning to enroll 208 eligible subjects. Participants will be treated with the investigational carotid artery stent system and followed up at discharge, 30 days, 6 months, and 12 months postoperatively to evaluate the safety and efficacy of the device for endovascular treatment of carotid artery stenosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Atherosclerosis; Carotid Artery Stenosis Asymptomatic; Carotid Artery Stenosis
• Intervention / Treatment: Device: Carotid Artery Stenting

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liqun Jiao; Phone Number: 010-83198277; Email: 13911224991@139.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital
    • Contact: Liqun Jiao; Phone Number: 010-83198277; Email: 13911224991@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

General Inclusion Criteria (all must be satisfied):

1. Age ≥18 years, either sex.
2. Preoperative carotid duplex ultrasound (DUS) confirms stenosis of the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation, and the subject is deemed suitable for endovascular intervention.
3. Intraoperative digital subtraction angiography (DSA) confirms symptomatic carotid artery stenosis ≥50% or asymptomatic carotid artery stenosis ≥80% (measured by NASCET criteria). Symptomatic is defined as a non-disabling ischemic stroke or transient ischemic attack (TIA), including cerebral hemisphere events or amaurosis fugax, occurring within 6 months prior to the procedure.
4. Reference vessel diameter at the target lesion ranges from 3.5 mm to 9.5 mm.
5. Voluntarily participates in this trial and signs the informed consent form.

CEA High-Risk Inclusion Criteria (at least one criterion must be met):

Clinical High-Risk Factors:

1. Age >80 years.
2. Low cardiac output [left ventricular ejection fraction (LVEF) <30%].
3. Untreated or poorly controlled arrhythmia (recurrent despite standard medical therapy or other treatment).
4. Cardiac insufficiency (New York Heart Association Class III-IV).
5. Recent myocardial infarction (occurring between 72 hours and 30 days prior to the procedure).
6. Unstable angina (Canadian Cardiovascular Society Class 3-4).
7. Severe chronic obstructive pulmonary disease (COPD), defined as forced expiratory volume in 1 second (FEV1) <50% of predicted value.

Anatomic High-Risk Factors:

1. Restenosis after prior carotid endarterectomy (CEA).
2. Contralateral carotid artery occlusion.
3. Tandem carotid artery lesions.
4. Carotid artery dissection.
5. Pseudoaneurysm.

Exclusion Criteria:

1. Target lesion caused by carotid arteritis.
2. Target lesion located at the ostium of the common carotid artery.
3. Severe, long-segment calcification or severe tortuosity at the target lesion preventing adequate stent delivery.
4. Target lesion is a complete occlusion.
5. Presence of large acute or subacute thrombus, or arteriovenous malformation adjacent to the target lesion.
6. Requirement for concurrent stenting or stenting in other territories (intracranial or extracranial) within 30 days after the procedure.
7. Intracranial hemorrhage within 3 months prior to the procedure.
8. Large-scale ischemic stroke within 30 days prior to the procedure.
9. Known intracranial aneurysm that cannot be treated in advance.
10. Known coagulation disorder (activated partial thromboplastin time [APTT] >3 times the upper limit of normal) or abnormal bleeding diathesis.
11. Known contraindication to heparin or antiplatelet agents.
12. Known allergy to device components, contrast agent, or related materials.
13. Severe hepatic or renal insufficiency (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >5 times the upper limit of normal; serum creatinine >3 times the upper limit of normal).
14. Uncontrolled severe hypertension (persistent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg).
15. Preoperative bradycardia (heart rate <40 beats per minute).
16. Preoperative modified Rankin Scale (mRS) score ≥3.
17. Malignant tumor with extensive metastasis.
18. Currently participating in another drug or device clinical trial.
19. Pregnant or lactating women, or women planning pregnancy within 1 year.
20. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this trial.

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: Carotid Artery Stenting; All participants will undergo carotid artery stenting (CAS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of In-Stent Restenosis (ISR)	Restenosis is defined as ≥50% diameter stenosis occurring within the stent or within 5 mm of the proximal or distal stent edge of the target carotid artery, as assessed by carotid duplex ultrasound (DUS).	through study completion, an average of 1 year
Incidence of Major Adverse Events (MAE)	Major adverse events (MAE) are defined as the composite incidence of: (1) death, stroke (ischemic or hemorrhagic), or myocardial infarction (MI) occurring within 30 days after the procedure; and (2) death or ipsilateral ischemic stroke of the target vessel occurring from 31 to 365 days after the procedure.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success Rate	Defined as the percentage of enrolled subjects in whom device success is achieved. Device success is defined as successful implantation (including delivery, deployment, and expansion) of the stent covering the target lesion, with successful retrieval of the delivery system.	Intraoperative
Procedural Success Rate	Defined as the percentage of enrolled subjects in whom procedural success is achieved. Procedural success is defined as successful implantation of the stent, with post-procedure angiography demonstrating ≤30% residual stenosis at the target lesion, and freedom from major adverse events (MAE; defined as all-cause death, stroke, or myocardial infarction) prior to hospital discharge.	Perioperative
Incidence of In-Stent Restenosis (ISR)	Defined as the percentage of enrolled subjects who develop ISR at 6 months post-procedure. ISR is defined as restenosis within the stent or within 5 mm proximal or distal to the stent edge of the target carotid artery, as assessed by carotid duplex ultrasound (DUS), with DUS criteria indicating ≥50% diameter stenosis.	6 months
Incidence of Target Lesion Revascularization (TLR)	The percentage of enrolled subjects who undergo TLR within 30 days, at 6 months, and at 12 months post-procedure. TLR is defined as any repeat revascularization (including any surgical or percutaneous intervention) of the target lesion after the initial index procedure.	30 days,6 months,12 months
Incidence of Ipsilateral Ischemic Stroke	Defined as the percentage of enrolled subjects who experience an ipsilateral ischemic stroke at 6 months and 12 months post-procedure. Ipsilateral ischemic stroke is defined as an ischemic stroke occurring in the cerebral hemisphere supplied by the target vessel (the carotid artery treated during the index procedure).	6 months,12 months
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)		through study completion, an average of 1 year
Incidence of Device Deficiencies		through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Suzhou Zenith Vascular SciTech Limited
• Collaborators: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 5, 2026
• First Submitted That Met QC Criteria: November 12, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 12, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis; Carotid Stenosis
• Other Study ID Numbers: ZTYL202401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No