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

December 3, 2018 updated by: Pawel Latacz, Jagiellonian University

New Ischemic Cerebral Lesions Revealed by the Imaging Magnetic Resonance Imaging After Endarterectomy vs. Stenting Under Proximal Protection for the Treatment of Symptomatic Carotid Stenosis: Results of a Randomised Prospective Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 comprised:

  • patient's age ≥ 18 years;
  • 60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means of Doppler sonography, CT angiography or catheter angiography);
  • diameter of the target internal carotid artery not more than 7 mm;
  • symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or reversible ischaemic neurological deficit);
  • localisation and morphology of the lesion making possible surgical eversion endarterectomy or endovascular angioplasty with stent implantation;
  • written informed consent.

Exclusion criteria comprised:

  • target lesion that has been previously stented;
  • highly calcified lesions;
  • very tortuous common and internal carotid arteries;
  • occlusion of the contralateral carotid artery without adequate collateral circulation through the circle of Willis (revealed by means of transcranial Doppler sonography);
  • anatomical contraindications for eversion endarterectomy;
  • acute ipsilateral stroke;
  • disabling stroke at any side;
  • other severe pathologies of the brain resulting is significant loss of cerebral tissue and/or significant neurological deficits, such as extensive previous stroke or multiple lacunar infarcts;
  • history of haemorrhagic transformation of ischaemic stroke;
  • severe comorbidities (such as cancer or decompensated heart failure);
  • allergy to aspirin, clopidogrel or ticlopidine;
  • allergy to iodinated contrast media;
  • pregnant women;
  • women of reproductive age who do not use effective contraception;
  • metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known contraindications for magnetic resonance imaging;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carotid Artery Stenting
Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma
Procedure: Carotid Artery Stenting
Carotid artery stenting was considered successful if there was no residual stenosis greater than 20%, and there was no dissection of target artery following the procedure.
Active Comparator: Endarterectomy carotid artery
Subjects will undergo carotid endarterectomy
Procedure: Endarterectomy carotid artery
Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.
Time Frame: 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.
2-4 days after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any Stroke, TIA, MI or death
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Pawel Latacz, PhD MD, Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137/KBL/OIL/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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