CEST-PROTECT: Proximal Flow Control With a Balloon Guide Catheter Plus Distal Embolic Protection: a Randomised, Open-label Trial Evaluating Cerebral Protection Techniques

NCT07841132 | Not Yet Recruiting DMC

• 1 other identifier: CEST-PROTECT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate whether a proximal-distal dual cerebral protection strategy can reduce the occurrence of new cerebral ischemic lesions compared with a single cerebral protection strategy in patients undergoing carotid artery stenting. Eligible participants will be randomly assigned to receive either dual cerebral protection using proximal flow control combined with a distal embolic protection device or conventional single cerebral protection. Brain magnetic resonance imaging will be performed after the procedure to assess new ischemic lesions. The study will also evaluate peri-procedural neurological events and other safety and efficacy outcomes.

Conditions

Carotid Artery Stenosis (Symptomatic and Asymptomatic)

Keywords

Carotid artery stenting; Embolic protection device; Proximal protection; Distal protection; Carotid artery stenosis; New cerebral infarction; Diffusion-weighted imaging; stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With at Least One New Ipsilateral Cerebral Ischemic Lesion on Diffusion-Weighted MRI

  The primary outcome is the proportion of participants with at least one new cerebral ischemic lesion on the side of the target carotid artery detected by diffusion-weighted magnetic resonance imaging (DWI) after carotid artery stenting, compared with the pre-procedural baseline MRI. New ischemic lesions will be assessed by an independent central imaging core laboratory blinded to treatment allocation.

  Within 72 hours after carotid artery stenting

Secondary Outcomes (12)

• Composite of Any Stroke or All-Cause Death Within 30 Days

  Within 30 (±7) days after carotid artery stenting

• Number and Distribution of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI

  Within 72 hours after carotid artery stenting

• Characteristics of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI

  Within 72 hours after carotid artery stenting

• Proportion of Participants With New Symptomatic or Asymptomatic Cerebral Infarction

  Within 30 (±7) days after carotid artery stenting

• Incidence of Ipsilateral Ischemic Stroke

  Within 7 (±2) and 30 (±7) days after carotid artery stenting

Study Arms (2)

BGC proximal flow control plus distal filter embolic protection device

EXPERIMENTAL

Carotid artery stenting will be performed via a transfemoral approach. Proximal flow control will be established using a balloon guide catheter (BGC) and combined with a distal filter embolic protection device, allowing the procedure to be performed under dual proximal and distal cerebral protection

Procedure: BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting

Single distal filter embolic protection device

ACTIVE COMPARATOR

Carotid artery stenting will be performed according to a standardized procedure under the protection of a distal embolic protection device. The selection criteria for the distal protection device and stent will be consistent with those used in the experimental group. The brand, model, size, rationale for selection, and details of device use will be fully documented.

Procedure: Single distal filter embolic protection device during carotid artery stenting

Interventions

BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting PROCEDURE

Carotid artery stenting will be performed via a transfemoral approach. Proximal flow control will be established using a balloon guide catheter (BGC) and combined with a distal filter embolic protection device. Carotid artery stenting will then be completed under dual proximal and distal cerebral protection.

BGC proximal flow control plus distal filter embolic protection device

Single distal filter embolic protection device during carotid artery stenting PROCEDURE

Carotid artery stenting will be performed according to a standardized procedure under the protection of a distal embolic protection device. The selection criteria for the distal protection device and stent will be consistent with those used in the experimental group. The brand, model, size, rationale for selection, and details of device use will be fully

Single distal filter embolic protection device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years, regardless of sex.
• Symptomatic carotid artery stenosis ≥50% or asymptomatic carotid artery stenosis ≥70%, with the degree of stenosis determined according to the prespecified NASCET method and confirmed by CTA, DSA, or MRA.
• Presence of at least one protocol-defined complex high-risk carotid stenosis feature confirmed by carotid ultrasonography, CTA, DSA, HR-VWI, or other protocol-specified imaging modalities.
• Written informed consent provided by the participant or legally authorized representative.

You may not qualify if:

• Other cerebrovascular lesions that may substantially increase peri-procedural risk or interfere with assessment of the primary outcome, including an untreated ipsilateral intracranial aneurysm \>5 mm, cerebral arteriovenous malformation, dural arteriovenous fistula, or other vascular lesions considered to pose significant risk by multidisciplinary assessment.
• Severe ipsilateral intracranial tandem stenosis ≥70% that is related to a recent ischemic event, is planned for intervention during the study follow-up period, or may interfere with attribution of post-procedural stroke; or complete occlusion of the contralateral internal carotid artery with an unacceptable risk of intolerance to proximal flow arrest.
• Technical conditions precluding carotid artery stenting or preventing safe implementation of either randomized cerebral protection strategy, including target-vessel occlusion or near-occlusion with distal collapse; free-floating thrombus or high-burden active intraluminal thrombus; absence of an appropriate landing zone for the distal embolic protection device or balloon flow-control segment in the common carotid artery; inability to safely cross, deploy, or retrieve the distal protection device; inability to safely and stably position the balloon guide catheter; severe aortic arch, supra-aortic, carotid-origin, or iliofemoral disease resulting in unacceptable transfemoral access risk; severe vascular tortuosity, angulation, or calcification resulting in unacceptable device-passage, vascular-injury, or stent-deployment risk; unacceptable risk of intolerance to proximal flow arrest; or any other condition preventing safe implementation of either randomized strategy.
• Modified Rankin Scale (mRS) score ≥3 after a recent stroke, or the presence of a large cerebral infarction, significant cerebral edema or mass effect, hemorrhagic transformation, impaired consciousness, progressive neurological deficits, or clinically unstable neurological status.
• Contraindication to contrast agents, antiplatelet therapy, anticoagulant therapy, or medications required during the procedure that cannot be adequately managed; or inability or expected inability to receive or complete protocol-required dual antiplatelet therapy.
• A serious medical condition precluding elective carotid artery stenting, including active bleeding, uncorrectable coagulopathy, severe renal dysfunction without adequate risk-control measures, persistent uncontrolled severe hypertension, active severe infection, myocardial infarction within 6 weeks before screening, unstable acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmia, or another serious systemic disease.
• Contraindication to MRI or anticipated inability to complete the protocol-required baseline and post-procedural MRI/DWI examinations.
• Current participation, or participation within 3 months before screening, in another clinical study that may affect the study intervention, safety assessment, or primary outcome evaluation; or planned major surgery or endovascular treatment during the peri-procedural period or 30-day follow-up that may interfere with assessment of study outcomes.
• Inability to understand or comply with study procedures, provide valid informed consent, complete the 30-day clinical follow-up or neurological assessments, or provide reliable primary outcome data; or life expectancy shorter than the required study follow-up period.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, substantially increases study-related risk, or may compromise the reliability of the study results.

Sponsors & Collaborators

• People's Hospital of Gaomi City: collaborator
• Henan Provincial People's Hospital: collaborator
• Linyi People's Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Shanxi Cardiovascular Hospital: collaborator
• Tianjin Huanhu Hospital: collaborator
• Xinqiao Hospital: collaborator
• Baoji third people's hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Xuanwu Hospital, Beijing: lead
• Fujian Zhangzhou hospital: collaborator
• Heze Municipal Hospital: collaborator
• The First People's Hospital of Mianyang: collaborator
• Nanyang Central Hospital: collaborator
• Union hospital of Fujian Medical University: collaborator
• The First Affiliated Hospital of Haerbin Medical University: collaborator
• Jiangsu Provincial People's Hospital: collaborator
• Jinan Hospital, Xuanwu Hospital, Capital Medical University: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Liaocheng Brains Hospital / Liaocheng People's Hospital: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Carotid Stenosis; Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jichang Luo, MD.

CONTACT

+86 13120136577; luojichang_dr@sina.com

Lingyan Meng, MD

CONTACT

+86 15015519994; lingyanmeng2001@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor blinded: Participants, treating physicians, and investigators will not be masked to treatment allocation because of the nature of the procedural intervention. Outcome assessors will be blinded to treatment allocation. Imaging outcomes will be evaluated by an independent central imaging core laboratory, clinical events by a blinded Clinical Events Committee, and neurological outcomes by trained independent blinded assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)