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TerminatedNCT03764306CARECarotidUpdated Dec 5, 2018

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

An interventional study of Carotid Artery Stenting and Endarterectomy carotid artery in Carotid Artery Stenosis, Carotid Atherosclerosis and Stroke, Ischemic, sponsored by Jagiellonian University. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Jagiellonian University · Not applicable, Interventional, and Treatment

Why this study was terminated
Problem with recruitment of patients meeting the inclusion criteria.

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled May 2015, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carotid Artery Stenosis
  • Carotid Atherosclerosis
  • Stroke, Ischemic

Keywords

  • carotid angioplaty
  • MRI DWI
03

In context

Carotid Stenosis

349 studies on the registry are indexed under Carotid Stenosis; 82 are open to participants now.

This study's enrollment of 31 is below the median of 104 across 188 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 160 studies on the registry; 35 are open to participants now.

Browse Jagiellonian University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
31 participants (actual)

Study arms

  • 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

  • Active comparator
    Endarterectomy carotid artery

    Subjects will undergo carotid endarterectomy

    Procedure: Endarterectomy carotid artery

Interventions

  • ProcedureCarotid 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.

  • ProcedureEndarterectomy carotid artery

    Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.

06

What researchers measure

Primary outcomes

  1. The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.

    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.

    Time frame: 2-4 days after procedure

Secondary outcomes

  1. Any Stroke, TIA, MI or death

    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.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Cremonesi A, Gieowarsingh S, Spagnolo B, Manetti R, Liso A, Furgieri A, Barattoni MC, Ghetti L, Tavazzi L, Castriota F. Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry). EuroIntervention. 2009 Nov;5(5):589-98. doi: 10.4244/eijv5i5a95. PubMed 20142180 ↗
  • Ansel GM, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A; Investigators for the ARMOUR Pivotal Trial. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):1-8. doi: 10.1002/ccd.22439. PubMed 20222019 ↗
  • Bersin RM, Stabile E, Ansel GM, Clair DG, Cremonesi A, Hopkins LN, Nikas D, Reimers B, Sievert H, Rubino P. A meta-analysis of proximal occlusion device outcomes in carotid artery stenting. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1072-8. doi: 10.1002/ccd.24433. Epub 2012 Jul 23. PubMed 22454248 ↗
  • Gao MY, Sillesen HH, Lorentzen JE, Schroeder TV. Eversion carotid endarterectomy generates fewer microemboli than standard carotid endarterectomy. Eur J Vasc Endovasc Surg. 2000 Aug;20(2):153-7. doi: 10.1053/ejvs.1999.1072. PubMed 10942686 ↗
  • Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, Howard G, Brott TG; CREST Investigators. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. doi: 10.1161/STROKEAHA.110.610212. Epub 2011 Feb 9. PubMed 21307169 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03764306
Lead sponsor
Jagiellonian University
Responsible party
Pawel Latacz (Principal Investigator, Jagiellonian University) — Principal investigator
First posted
Dec 5, 2018
Start date
May 1, 2015
Primary completion
May 1, 2015
Completion
Oct 30, 2018
Last update
Dec 5, 2018

Study contacts

Pawel Latacz, PhD MD
principal investigator · Jagiellonian University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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