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

NCT03764306 | Terminated

• 1 other identifier: 137/KBL/OIL/2015
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carotid Artery Stenosis; Carotid Atherosclerosis; Stroke, Ischemic

Keywords

carotid angioplaty; MRI DWI

Outcome Measures

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.

  2-4 days after procedure

Secondary Outcomes (1)

• Any Stroke, TIA, MI or death

  6 months

Study Arms (2)

Carotid Artery Stenting

ACTIVE COMPARATOR

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

Endarterectomy carotid artery

ACTIVE COMPARATOR

Subjects will undergo carotid endarterectomy

Procedure: Endarterectomy carotid artery

Interventions

Carotid Artery Stenting PROCEDURE

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.

Carotid Artery Stenting

Endarterectomy carotid artery PROCEDURE

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

Endarterectomy carotid artery

Eligibility Criteria

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

You may qualify if:

• patient's age ≥ 18 years;
• % 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jagiellonian University: lead

Related Publications (5)

• 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.

  PMID: 20142180 RESULT

• 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.

  PMID: 20222019 RESULT

• 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.

  PMID: 22454248 RESULT

• 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.

  PMID: 10942686 RESULT

• 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.

  PMID: 21307169 RESULT

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases; Ischemic Stroke

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pawel Latacz, PhD MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 5, 2018
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: October 30, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-11