Study of Blood Flow Changes and Microemboli During Carotid Surgery

NCT ID: NCT01343615

Last Updated: 2011-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.

Detailed Description

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Conditions

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Carotid Endarterectomy Percutaneous Transluminal Angioplasty Cognitive Aspects Diffusion Weighted MRI

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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carotid stenting

Group Type ACTIVE_COMPARATOR

carotid stenting

Intervention Type PROCEDURE

A group of patients will be operated by endovascular technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects.

carotid endarterectomy

Group Type ACTIVE_COMPARATOR

carotid endarterectomy

Intervention Type PROCEDURE

A group of patients will be operated by open technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects

Interventions

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carotid stenting

A group of patients will be operated by endovascular technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects.

Intervention Type PROCEDURE

carotid endarterectomy

A group of patients will be operated by open technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* acoustic window for transcranial Doppler
* surgical criteria proposed by the NASCET and ACAS studies
* postoperative follow-up for at least six months
* patient consent

Exclusion Criteria

* carotid restenosis
* combined surgery
* emergency surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Unicamp

Locations

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Hospital de Clínicas da Unicamp

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Germano da Paz Oliveira

Role: primary

Luciana A. Moreira da Paz Oliveira

Role: backup

Other Identifiers

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MES2011

Identifier Type: -

Identifier Source: org_study_id