Carotid Artery DiseasesNCT06882954
The Management of Asymptomatic Carotid Stenosis
An observational study of Carotid Artery Diseases and Carotid Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Carotid Stenosis
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients with significant internal carotid artery stenosis referred to the Unit of Vascular Surgery of Fondazione Policlinico Gemelli IRCCS Rome for carotid artery endoarterectomy and stenting
Who may be able to join
- 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
Who cannot join
- Symptomatic carotid artery stenosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00167
Giovanni Tinelli, 0039 0630157205, giovanni.tinelli@policlinicogemelli.it
About this study
Official title: The Management of Asymptomatic Carotid Stenosis: Monocentric Experience
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.
- Conditions
- Carotid Artery Diseases, Carotid Stenosis
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke rate
Rate of stroke after the procedure
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882954
- Sponsor's protocol ID
- 2691
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Asymptomatic Carotid Stenosis: Monocentric Experience
- ClinicalTrials.gov ID
- NCT06882954
- Acronym / sponsor ID
- 2691
- Conditions
- Carotid Artery Diseases, Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with significant internal carotid artery stenosis referred to the Unit of Vascular Surgery of Fondazione Policlinico Gemelli IRCCS Rome for carotid artery endoarterectomy and stenting
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Symptomatic carotid artery stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stroke rate
Time frame: Through study completion, an average of 1 year
Rate of stroke after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases and Carotid Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke rate (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.