Stroke, Ischemic Clinical Trial
— CARECarotidOfficial title:
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
Verified date | November 2018 |
Source | Jagiellonian University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 31 |
Est. completion date | October 30, 2018 |
Est. primary completion date | May 1, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Jagiellonian University |
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: r — View Citation
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 — View Citation
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 Expe — View Citation
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. — View Citation
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 Endarterect — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 6 months |
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