New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis

Not Applicable

Terminated

• Conditions: Carotid Atherosclerosis; Stroke, Ischemic; Carotid Artery Stenosis
• Interventions: Procedure: Endarterectomy carotid artery; Procedure: Carotid Artery Stenting

• Registration Number: NCT03764306
• Lead Sponsor: Jagiellonian University

Brief Summary

Background and purpose. Even if periprocedural cerebral microembolism associated with carotid endarterectomy or stenting usually does not manifest as clinically overt stroke, neuropsychological disturbances resulting from these events represent an important clinical and socioeconomic problem. Still, it remains unclear whether the use proximal protection can lower the incidence of cerebral embolism associated with the treatment of carotid stenosis.

Materials and methods. This was a prospective randomised single-centre study, which was aimed at comparison of surgical eversion endarterectomy with stenting under proximal protection in symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment and neurologic events.

Detailed Description

The CARECarotid was a prospective randomised single-centre study, which was performed in the University Hospital in Kraków. It was planned to evaluate 50 patients presenting with symptomatic lesions of the internal carotid artery.

Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection. All patients provided their written informed consent to undergo the procedures and to participate in this trial.

In all surgical patients carotid endarterectomy will perform using the eversion technique. All surgical endarterectomies will perform under cervical block anaesthesia.

Perioperatively patients in the surgical arm received aspirin; other antiplatelet or anticoagulant agents were not administered during 5 days before surgery.

All procedures in carotid artery stenting will perform with proximal protection system - the Mo.Ma (Medtronic, Minneapolis, MN, USA) device. The investigators will implante stents that were tailored to the localisation of lesions and morphology of carotid arteries: Carotid Wallstent (Boston Scientific, Natick, MA, USA, and in patients with tortuous arteries Precise Pro RX (Cordis, Fremont, CA, USA) or Roadsaver (Terumo, Tokyo, Japan). Patients in the stent arm will receive clopidogrel 75 mg/day and aspirin 75 mg/day. These drugs were administered during 3 days before planned procedure and then 3-6 months after stent implantation. All patients will have MRI DWI performed before and 2-4 days after procedures in both groups. Within 6 months there will be an evaluation of the incidence of neurological events.

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2015-05-01
• Study Completion: 2018-10-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endarterectomy carotid artery	Endarterectomy carotid artery	Subjects will undergo carotid endarterectomy
Carotid Artery Stenting	Carotid Artery Stenting	Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma

Primary Outcome Measures

Name	Time	Method
The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.	2-4 days after procedure	Number of patients with treatment related new ipsilateral cerebral embolic lesions in brain diffusion-weighted magnetic resonance imaging within 2-4 days post carotid artery stenting and endarterectomy. Number, size and location new cerebral lesions per patients in both groups.

Secondary Outcome Measures

Name	Time	Method
Any Stroke, TIA, MI or death	6 months	Number of patients with occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 6 months after carotid artery stenting and endarterectomy.