Cerebral AneurysmNCT05713825
Multidimensional Evaluation of Patients With Ruptured or Unruptured Cerebral Aneurysm Undergoing Endovascular or Surgical Treatment
An observational study of Cerebral Aneurysm, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Cerebral aneurysms are common changes in intracranial angioarchitecture. Unruptured aneurysms are increasingly identified thanks to the imaging techniques used in daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Endovascular embolization or surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2023to 31 Dec 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Given the purely descriptive nature of the primary objective, we do not proceed with the formal calculation of the sample size but a sample of N=500 patients is proposed.
Who may be able to join
- age > 18 years
- ruptured or unruptured cerebral aneurysm with consistent neurologic and radiologic evidence.
- CT without contrast medium and CT angiography, demonstrating the SAH and the aneurysm.
- Execution of an endovascular embolization procedure (which is indicated by a neurosurgeon and interventional neuroradiologist) or surgical treatment.
Who cannot join
- non-aneurysmal causes of SAH (example: AVMs, AVDs and trauma).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma, RM, 00168
Andrea M Alexandre, MD, MSc, +390630151, andrea.alexandre@policlinicogemelli.it
About this study
Cerebral aneurysms are common changes in intracranial angioarchitecture. Unruptured aneurysms are increasingly identified thanks to the imaging techniques used in daily clinical practice. Since bleeding remains a highly dramatic event burdened by significant morbidity-mortality (about 50%), endovascular therapy, in combination with classic surgical therapy, is an essential element in contemporary medicine.
Endovascular and surgical treatment represent the standard of care. The rationale of this study is to identify clinical and radiological characteristics, mainly neuro-radiological ones, not fully explored in previous studies, which can help predict the outcome of patients affected by cerebral aneurysm.
Read more
The study will have the characteristics of a retrospective study on patients with cerebral aneurysm treated at our center from 1 January 2015 to 31 December 2023.
Objective of the study is the multidimensional evaluation in patients with cerebral aneurysms, ruptured and unruptured, undergoing an endovascular embolization procedure or surgical treatment.
Read the detailed description
Cerebral aneurysmal disease affects 2-5% of the world population, with 0.7-1.9% of cases of rupture resulting in subarachnoid hemorrhage (SAH). The most affected age group is wide - from 30 to 60 years - with a ratio between male and female gender equal to 1.6.
SAH accounts for approximately 5% of strokes and is burdened by high mortality and disability rates; in this particular situation, the patient is subjected in the shortest time possible to a clinical-anamnestic framework, to evaluate the severity of the clinical picture and quantify it through the use of the Hunt \& Hess scale, which is followed by the direct tomographic examination, to evaluate the extent of the lesions.
Recently, numerous developments have been observed in the treatment, elective or acute, of cerebral aneurysm, such as the introduction of new therapeutic devices, such as the flow diversion stent or "flow diverter".
The primary objective of the treatment of a cerebral aneurysm must be different on the basis of the type of lesion and the patient's clinical conditions: while, in fact, the treatment of a ruptured aneurysm has the primary aim of avoiding immediate rebleeding and facilitating treatment intensive, the goal of treatment of an unruptured aneurysm must be the achievement of a stable result, up to and including exclusion from the circulation.
Endovascular therapy has reached such prominence that, in most teams, the right of first refusal in the treatment of aneurysmal subarachnoid hemorrhage rests with the interventional neuroradiologist and no longer with the neurosurgeon.
The scientific literature is now rich in this regard, and in particular the two ISUIA (International Study of Unruptured Intracranial) trials and the ISAT (International Subarachnoid Aneurysm Trial ) are two points of reference in the management of intracranial aneurysms nowadays, focusing on endovascular treatment, especially in suitable anatomical conditions.
Although clinical trials and meta-analyses have dispelled any doubts about the validity/necessity of the therapies, the authors are convinced that there may be clinical and radiological characteristics, not fully explored in the aforementioned studies, which can help predict the outcome of these patients. The finding of these variables, if confirmed by subsequent trials aimed at the purpose, could in the future guide the selection of patients to undergo treatment as well as guide the choice of the best technique, endovascular or surgical in primis, to be applied according to the characteristics of each patient .
Therefore, it is the authors' intention to conduct a retrospective observational study with the aim of exploring the possible implication of new variables that can predict with sufficient accuracy the outcome of patients with ruptured and unruptured cerebral aneurysms; a possible positive response could be followed by a more structured clinical trial with which to derive the appropriate conclusions with greater methodological soundness.
- Conditions
- Cerebral Aneurysm
- Being tested
- Endovascular embolization or surgery
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular embolization or surgeryProcedure or surgery
- Endovascular embolization may be done with coils, remodeling technique (coils and balloon), stent and coils, flow-diverter, endosaccular devices. The access is through the femoral or radial artery.
- Surgery is considered the standard neurosurgical procedure of aneurysm clipping.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence at 90 days assessed by Rankin scale (mRS).
A good clinical outcome will be defined as an modified Rankin Scale (mRS) score between 0 and 2 (mRS 0 identifies a patients with no symptoms, 6 identifies a dead patient).
Measured: 90 days
Secondary outcomes (3)
efficacy of endovascular treatment using the Raymond-Roy scale
Raymond-Roy scale:
class I: complete obliteration class II: residual neck class III: residual aneurysm
Measured: at the end of the endovascular procedure
90-day in-hospital mortality.
Any cause of death in patients treated for a cerebral aneurysm (considering endovascular or surgical procedures)
Measured: 90 days
post-procedural symptomatic stroke/haemorrhage.
Any type of symptomatic ischemic or hemorrhagic event following endovascular or surgical procedures
Measured: 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start31 Jan 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Andrea, MD MSc, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713825
- Sponsor's protocol ID
- 3583
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Evaluation of Patients With Ruptured or Unruptured Cerebral Aneurysm Undergoing Endovascular or Surgical Treatment
- ClinicalTrials.gov ID
- NCT05713825
- Acronym / sponsor ID
- 3583
- Conditions
- Cerebral Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Feb 2023 (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.
Cerebral aneurysms are common changes in intracranial angioarchitecture. Unruptured aneurysms are increasingly identified thanks to the imaging techniques used in daily clinical practice. Since bleeding remains a highly dramatic event burdened by significant morbidity-mortality (about 50%), endovascular therapy, in combination with classic surgical therapy, is an essential element in contemporary medicine.
Endovascular and surgical treatment represent the standard of care. The rationale of this study is to identify clinical and radiological characteristics, mainly neuro-radiological ones, not fully explored in previous studies, which can help predict the outcome of patients affected by cerebral aneurysm.
The study will have the characteristics of a retrospective study on patients with cerebral aneurysm treated at our center from 1 January 2015 to 31 December 2023.
Objective of the study is the multidimensional evaluation in patients with cerebral aneurysms, ruptured and unruptured, undergoing an endovascular embolization procedure or surgical treatment.
Detailed description
Cerebral aneurysmal disease affects 2-5% of the world population, with 0.7-1.9% of cases of rupture resulting in subarachnoid hemorrhage (SAH). The most affected age group is wide - from 30 to 60 years - with a ratio between male and female gender equal to 1.6.
SAH accounts for approximately 5% of strokes and is burdened by high mortality and disability rates; in this particular situation, the patient is subjected in the shortest time possible to a clinical-anamnestic framework, to evaluate the severity of the clinical picture and quantify it through the use of the Hunt \& Hess scale, which is followed by the direct tomographic examination, to evaluate the extent of the lesions.
Recently, numerous developments have been observed in the treatment, elective or acute, of cerebral aneurysm, such as the introduction of new therapeutic devices, such as the flow diversion stent or "flow diverter".
The primary objective of the treatment of a cerebral aneurysm must be different on the basis of the type of lesion and the patient's clinical conditions: while, in fact, the treatment of a ruptured aneurysm has the primary aim of avoiding immediate rebleeding and facilitating treatment intensive, the goal of treatment of an unruptured aneurysm must be the achievement of a stable result, up to and including exclusion from the circulation.
Endovascular therapy has reached such prominence that, in most teams, the right of first refusal in the treatment of aneurysmal subarachnoid hemorrhage rests with the interventional neuroradiologist and no longer with the neurosurgeon.
The scientific literature is now rich in this regard, and in particular the two ISUIA (International Study of Unruptured Intracranial) trials and the ISAT (International Subarachnoid Aneurysm Trial ) are two points of reference in the management of intracranial aneurysms nowadays, focusing on endovascular treatment, especially in suitable anatomical conditions.
Although clinical trials and meta-analyses have dispelled any doubts about the validity/necessity of the therapies, the authors are convinced that there may be clinical and radiological characteristics, not fully explored in the aforementioned studies, which can help predict the outcome of these patients. The finding of these variables, if confirmed by subsequent trials aimed at the purpose, could in the future guide the selection of patients to undergo treatment as well as guide the choice of the best technique, endovascular or surgical in primis, to be applied according to the characteristics of each patient .
Therefore, it is the authors' intention to conduct a retrospective observational study with the aim of exploring the possible implication of new variables that can predict with sufficient accuracy the outcome of patients with ruptured and unruptured cerebral aneurysms; a possible positive response could be followed by a more structured clinical trial with which to derive the appropriate conclusions with greater methodological soundness.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Given the purely descriptive nature of the primary objective, we do not proceed with the formal calculation of the sample size but a sample of N=500 patients is proposed.
Key inclusion criteria (4 listed)
- age > 18 years
- ruptured or unruptured cerebral aneurysm with consistent neurologic and radiologic evidence.
- CT without contrast medium and CT angiography, demonstrating the SAH and the aneurysm.
- Execution of an endovascular embolization procedure (which is indicated by a neurosurgeon and interventional neuroradiologist) or surgical treatment.
Key exclusion criteria (1 listed)
- non-aneurysmal causes of SAH (example: AVMs, AVDs and trauma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular embolization or surgery* Endovascular embolization may be done with coils, remodeling technique (coils and balloon), stent and coils, flow-diverter, endosaccular devices. The access is through the femoral or radial artery. * Surgery is considered the standard neurosurgical procedure of aneurysm clipping. | Procedure or surgery | – |
Primary outcome
Functional independence at 90 days assessed by Rankin scale (mRS).
Time frame: 90 days
A good clinical outcome will be defined as an modified Rankin Scale (mRS) score between 0 and 2 (mRS 0 identifies a patients with no symptoms, 6 identifies a dead patient).
3 secondary outcomes
efficacy of endovascular treatment using the Raymond-Roy scale
Time frame: at the end of the endovascular procedure
90-day in-hospital mortality.
Time frame: 90 days
post-procedural symptomatic stroke/haemorrhage.
Time frame: 48 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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. This study is not recruiting at the moment.
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 Cerebral Aneurysm, 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 4 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea M Alexandre, MD, MSc (00390630151, andrea.alexandre@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at 90 days assessed by Rankin scale (mRS). (time frame: 90 days). 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 8 Feb 2023.