Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting: A Randomized Study (EMBO-PROTECT)

Instituto de Investigación Marqués de Valdecilla0 个研究点目标入组 126 人开始时间: 2026年7月1日最近更新: 2026年5月8日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 126

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization. This prospective randomized study evaluates the safety and efficacy of proximal embolic protection using a balloon guide catheter during CAS by comparing the incidence of diffusion-weighted MRI-detected microembolisms and symptomatic thromboembolic events between protected and unprotected procedures.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

盲法说明

Outcome assessors (neurologists and radiologists evaluating diffusion-weighted MRI images) are blinded to treatment allocation. Participants and interventional staff are not blinded due to the nature of the procedure.

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 18 years
•Symptomatic or asymptomatic carotid artery stenosis
•Candidate for carotid artery stenting
•Written informed consent provided

排除标准

•Vascular anatomy unsuitable for balloon guide catheter placement
•Severe renal failure
•Previous disabling stroke or symptomatic intracranial hemorrhage
•Evidence of carotid thrombus
•Severe common carotid artery lesion
•Chronic atrial fibrillation on oral anticoagulation
•Acute coronary syndrome within 30 days
•Contraindications to anticoagulant or antiplatelet therapy
•Contraindications to MRI
•Contrast media allergy
•Lack of prior dual antiplatelet therapy

研究者

发起方

Instituto de Investigación Marqués de Valdecilla

申办方类型

Other

责任方

Sponsor

相似试验

尚未招募

4 期

Use of drug coated balloons for ostial coronary lesions

CTRI/2024/07/069759VMMC and Safdarjung hospital60

尚未招募

不适用

The PICCOLETO XI A-PREP StudyCoronary Artery Disease

NCT07391033Fondazione Ricerca e Innovazione Cardiovascolare ETS500

招募中

不适用

To study whether side branch strut opening using kissing balloon inflation after provisional left main stenting will improve the side branch outcome.

CTRI/2024/09/073616Principal Investigator630

尚未招募

不适用

Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCADMulti Vessel Coronary Artery DiseasePercutaneous Coronary Intervention

NCT07539324Genoss Co., Ltd.892

Enrolling By Invitation

不适用

Effectiveness of Surgical and Diagnostic Methods in Cerebral Vascular Occlusive Disease

NCT07396025National Centre for Neurosurgery, Republic of Kazakhstan60