The Management of Asymptomatic Carotid Stenosis

NCT ID: NCT06882954

Last Updated: 2025-03-19

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

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2027-12-31

Brief Summary

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Carotid stenosis are asymptomatic if no hemispheric or retinal symptoms have appeared in the 6 months preceding the discovery of the stenosis. Asymptomatic carotid stenosis (ACS) accounts for about ¾ of all carotid lesions. The goal of treating carotid stenosis is to prevent a stroke. While carotid surgery is recommended in the elderly patients in cases of symptomatic carotid stenosis, that of ACS in patients over 75 years old, even when tight, remains subject to many controversies. Indeed, the debate, concerning the benefit to be expected from a surgical procedure or a possible angioplasty procedure, is not yet closed. The aim of our study, through a retrospective evaluation of the results of all consecutive carotid endarterectomy (CEA) and stenting in the participating center.

Detailed Description

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Conditions

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Carotid Artery Diseases Carotid Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Asymptomatic carotid stenosis
* Patient with degree of carotid stenosis greater than 80% measured by the maximum systolic velocity at the site of the stenosis which must have been greater than 250 cm/s
* Ultrasound characteristics of a possibly unstable plaque

Exclusion Criteria

* Symptomatic carotid artery stenosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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TINELLI GIOVANNI

Associate Professor of Vascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Giovanni Tinelli

Role: primary

0039 0630157205

Other Identifiers

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2691

Identifier Type: -

Identifier Source: org_study_id

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