StrokeNCT05708079
Multidimensional Evaluation of Patients With Acute Ischemic Stroke Undergoing Pharmacological and Endovascular Revascularization Procedures for the Identification of Positive Prognostic Factors
An observational study of Stroke and Endovascular Thrombectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Systemic and endovascular thrombolytic treatments in acute cerebral ischemic stroke caused by occlusion of large caliber vessels are currently the standard of care for the acute treatment of stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Endovascular Thrombectomy, Ischemic Stroke
- What is being tested?
- Endovascular thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 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
- No healthy volunteers
- Adult, Older adult
Study population: Descriptive observational study on patients with acute ischemic stroke treated at the Policlinico A. Gemelli- IRCCS from 1 January 2016 to 31 December 2023.
Who may be able to join
- age > 18 years
- Acute ischemic stroke with consistent neurologic and radiologic evidence.
- Performing a CT without contrast and a triphasic CT angiography.
- Execution of mechanical endovascular thrombectomy procedure (whose indication is placed by a neurologist and interventional neuroradiologist).
Who cannot join
- patients lost to follow-up (e.g. back-transfer).
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
In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Systemic and endovascular thrombolytic treatments in acute cerebral ischemic stroke caused by occlusion of large caliber vessels are currently the standard of care for the acute treatment of stroke.
The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life".
Read more
The study will have the characteristics of a descriptive observational study on patients suffering from acute ischemic stroke treated at the Policlinico A. Gemelli-IRCCS from 1 January 2016 to 31 December 2023. These data will be compared with a retrospective control group of patients undergoing mechanical thrombectomy for cerebral ischemic stroke in our polyclinic.
The primary endpoint is the outcome of patients treated with mechanical endovascular thrombectomy evaluated with the modified Ranking Scale at 90 days, while as secondary endpoints some individual characteristics of the patient will be considered (sex, age, clinical history, etc.), characteristics of the thrombus (anatomical-pathological, radiological etc) and related to acute management (therapy, rehabilitation, etc).
Read the detailed description
Background and rationale of the study In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Recently, while some developments have been observed in the acute treatment of ischemic stroke such as the introduction of thrombolysis with rt-PA in the acute phase, in the face of acceptable side effects (NINDS, SITS MOST, ECASS), new treatments have been approved for the acute treatment of some types of acute stroke, such as endovascular treatment.
Endovascular treatment in acute cerebral ischemic stroke caused by large vessel occlusion has become the standard of care following the publication of five multicenter randomized trials performed in different reference centers in 2015. In these studies, the treatment cut-off was set at 4.5 hours, a previously validated standard time for intravenous thrombolysis, only for one of these was it instead set at 6 hours. In 2018, two other trials were published, which demonstrated the efficacy of the treatment even beyond 6 hours, one 16 hours after onset, the other up to 24 hours.
Several case studies have now been published which confirm the results of these latest trials, and others which demonstrate how the indications can be extended even beyond those envisaged by the most recent international guidelines.
The development of this therapeutic approach has therefore upset what was the standard therapy and consequently the natural history of many patients suffering from cerebral ischemic stroke.
The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life" (outside a randomized multicenter trial), as well as to define more precisely indications, contraindications , benefits (outcome at 90 days measured with the modified Ranking Scale) and possible complications of this technique. Furthermore, the presence of cofactors relating to acute management, thrombus characteristics and the data emerging from neuro-imaging performed in the acute phase that can determine better results will be evaluated.
Working hypothesis: in the various trials reported, divergences emerge in terms of characteristics of the patients enrolled, treatment timing and patient management in the acute phase. The hypothesis is that some characteristics of the patient, of the thrombus or of the type of treatment are important for the success of the treatment and their identification would allow to individualize the treatment determining better outcomes.
- Conditions
- Stroke, Endovascular Thrombectomy, Ischemic Stroke
- Being tested
- Endovascular thrombectomy
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular thrombectomyProcedure or surgery
An endovascular thrombectomy is the removal of a thrombus (blood clot) under image guidance. A thrombectomy is most commonly performed for an arterial embolism, which is an arterial blockage often caused by atrial fibrillation, a heart rhythm disorder.
What is being measured
The primary outcome is the main question the study is designed to answer.
3 months mRS
outcome of patients treated by mechanical endovascular thrombectomy evaluated with modified Ranking Scale at 90 days.
Measured: 3 months
Secondary outcomes (1)
Radiological-clinical correlation
Correlation between radiological parameters (site of occlusion, ASPECT score on CT without contrast medium, angiographic mTICI at the end of the procedure) and clinical parameters (age, NIHSS at onset) with outcome at 90 days.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jun 2020
- 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.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 600 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
- NCT05708079
- Sponsor's protocol ID
- 3004
- Status last verified
- Feb 2023
- First submitted
- 23 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
Publications
Alexandre AM, Pedicelli A, Valente I, Scarcia L, Giubbolini F, D'Argento F, Lozupone E, Distefano M, Pilato F, Colosimo C. May endovascular thrombectomy without CT perfusion improve clinical outcome? Clin Neurol Neurosurg. 2020 Nov;198:106207. doi: 10.1016/j.clineuro.2020.106207. Epub 2020 Sep 7.
PubMed 32950754Alexandre AM, Valente I, Consoli A, Piano M, Renieri L, Gabrieli JD, Russo R, Caragliano AA, Ruggiero M, Saletti A, Lazzarotti GA, Pileggi M, Limbucci N, Cosottini M, Cervo A, Viaro F, Vinci SL, Commodaro C, Pilato F, Pedicelli A. Posterior Circulation Endovascular Thrombectomy for Large-Vessel Occlusion: Predictors of Favorable Clinical Outcome and Analysis of First-Pass Effect. AJNR Am J Neuroradiol. 2021 May;42(5):896-903. doi: 10.3174/ajnr.A7023. Epub 2021 Mar 4.
PubMed 33664106Alexandre AM, Valente I, Frisullo G, Morosetti R, Genovese D, Bartolo A, Gigli R, Rollo C, Scarcia L, Carosi F, Fortunato G, D'Argento F, Calabresi P, Della Marca G, Pedicelli A, Broccolini A. Mechanical thrombectomy in patients with stroke due to large vessel occlusion in the anterior circulation and low baseline NIHSS score. J Integr Neurosci. 2021 Sep 30;20(3):645-650. doi: 10.31083/j.jin2003068.
PubMed 34645097Pilato F, Silva S, Valente I, Distefano M, Broccolini A, Brunetti V, Caliandro P, Marca GD, Di Iorio R, Frisullo G, Monforte M, Morosetti R, Piano C, Calandrelli R, Capone F, Alexandre A, Pedicelli A, Colosimo C, Caricato A. Predicting Factors of Functional Outcome in Patients with Acute Ischemic Stroke Admitted to Neuro-Intensive Care Unit-A Prospective Cohort Study. Brain Sci. 2020 Nov 26;10(12):911. doi: 10.3390/brainsci10120911.
PubMed 33256264Di Iorio R, Pilato F, Valente I, Laurienzo A, Gaudino S, Frisullo G, Profice P, Cottonaro S, Alexandre A, Caliandro P, Morosetti R, Lozupone E, D'Argento F, Pedicelli A, Colosimo C, Calabresi P, Della Marca G, Broccolini A. Role of Favorable Perfusion Imaging in Predicting the Outcome of Patients with Acute Ischemic Stroke due to Large Vessel Occlusion Undergoing Effective Thrombectomy: A Single-Center Study. Cerebrovasc Dis Extra. 2021;11(1):1-8. doi: 10.1159/000513025. Epub 2021 Jan 15.
PubMed 33454704Alexandre AM, Valente I, Consoli A, Trombatore P, Scarcia L, Piano M, Limbucci N, Gabrieli JD, Russo R, Caragliano AA, Ruggiero M, Saletti A, Lazzarotti GA, Pileggi M, Cosottini M, Pilato F, Slomka A, Colo F, Giubbolini F, Frisullo G, Della Marca G, Broccolini A, Pedicelli A. Posterior Circulation Endovascular Thrombectomy for Large Vessels Occlusion in Patients Presenting with NIHSS Score </= 10. Life (Basel). 2021 Dec 17;11(12):1423. doi: 10.3390/life11121423.
PubMed 34947955Alexandre AM, Colo F, Brunetti V, Valente I, Frisullo G, Pedicelli A, Scarcia L, Rollo C, Falcou A, Milonia L, Andrighetti M, Piano M, Macera A, Commodaro C, Ruggiero M, Da Ros V, Bellini L, Lazzarotti GA, Cosottini M, Caragliano AA, Vinci SL, Gabrieli JD, Causin F, Panni P, Roveri L, Limbucci N, Arba F, Pileggi M, Bianco G, Romano DG, Diana F, Semeraro V, Burdi N, Ganimede MP, Lozupone E, Fasano A, Lafe E, Cavallini A, Russo R, Bergui M, Calabresi P, Della Marca G, Broccolini A. Mechanical thrombectomy in minor stroke due to isolated M2 occlusion: a multicenter retrospective matched analysis. J Neurointerv Surg. 2023 Nov;15(e2):e198-e203. doi: 10.1136/jnis-2022-019557. Epub 2022 Oct 12.
PubMed 36223995Pilato F, Valente I, Calandrelli R, Alexandre A, Arena V, Dell'Aquila M, Broccolini A, Della Marca G, Morosetti R, Frisullo G, Brunetti V, Distefano M, Pedicelli A, Colosimo C, Di Lazzaro V. Clot evaluation and distal embolization risk during mechanical thrombectomy in anterior circulation stroke. J Neurol Sci. 2022 Jan 15;432:120087. doi: 10.1016/j.jns.2021.120087. Epub 2021 Dec 14.
PubMed 34933250Alexandre AM, Valente I, Pedicelli A, Pezzullo AM, Colo F, Scarcia L, Romi A, Piano M, Macera A, Gabrieli JD, Cester G, Caragliano AA, Vinci SL, Ruggiero M, Commodaro C, Saletti A, Lazzarotti GA, Cosottini M, Da Ros V, Bellini L, Lozupone E, Paladini A, Brunetti V, Morosetti R, Frisullo G, Calabresi P, Marca GD, Broccolini A. Mechanical thrombectomy in acute ischemic stroke due to large vessel occlusion in the anterior circulation and low baseline National Institute of Health Stroke Scale score: a multicenter retrospective matched analysis. Neurol Sci. 2022 May;43(5):3105-3112. doi: 10.1007/s10072-021-05771-5. Epub 2021 Nov 29.
PubMed 34843020
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 Acute Ischemic Stroke Undergoing Pharmacological and Endovascular Revascularization Procedures for the Identification of Positive Prognostic Factors
- ClinicalTrials.gov ID
- NCT05708079
- Acronym / sponsor ID
- 3004
- Conditions
- Stroke, Endovascular Thrombectomy, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 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.
In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Systemic and endovascular thrombolytic treatments in acute cerebral ischemic stroke caused by occlusion of large caliber vessels are currently the standard of care for the acute treatment of stroke.
The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life".
The study will have the characteristics of a descriptive observational study on patients suffering from acute ischemic stroke treated at the Policlinico A. Gemelli-IRCCS from 1 January 2016 to 31 December 2023. These data will be compared with a retrospective control group of patients undergoing mechanical thrombectomy for cerebral ischemic stroke in our polyclinic.
The primary endpoint is the outcome of patients treated with mechanical endovascular thrombectomy evaluated with the modified Ranking Scale at 90 days, while as secondary endpoints some individual characteristics of the patient will be considered (sex, age, clinical history, etc.), characteristics of the thrombus (anatomical-pathological, radiological etc) and related to acute management (therapy, rehabilitation, etc).
Detailed description
Background and rationale of the study In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Recently, while some developments have been observed in the acute treatment of ischemic stroke such as the introduction of thrombolysis with rt-PA in the acute phase, in the face of acceptable side effects (NINDS, SITS MOST, ECASS), new treatments have been approved for the acute treatment of some types of acute stroke, such as endovascular treatment.
Endovascular treatment in acute cerebral ischemic stroke caused by large vessel occlusion has become the standard of care following the publication of five multicenter randomized trials performed in different reference centers in 2015. In these studies, the treatment cut-off was set at 4.5 hours, a previously validated standard time for intravenous thrombolysis, only for one of these was it instead set at 6 hours. In 2018, two other trials were published, which demonstrated the efficacy of the treatment even beyond 6 hours, one 16 hours after onset, the other up to 24 hours.
Several case studies have now been published which confirm the results of these latest trials, and others which demonstrate how the indications can be extended even beyond those envisaged by the most recent international guidelines.
The development of this therapeutic approach has therefore upset what was the standard therapy and consequently the natural history of many patients suffering from cerebral ischemic stroke.
The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life" (outside a randomized multicenter trial), as well as to define more precisely indications, contraindications , benefits (outcome at 90 days measured with the modified Ranking Scale) and possible complications of this technique. Furthermore, the presence of cofactors relating to acute management, thrombus characteristics and the data emerging from neuro-imaging performed in the acute phase that can determine better results will be evaluated.
Working hypothesis: in the various trials reported, divergences emerge in terms of characteristics of the patients enrolled, treatment timing and patient management in the acute phase. The hypothesis is that some characteristics of the patient, of the thrombus or of the type of treatment are important for the success of the treatment and their identification would allow to individualize the treatment determining better outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Descriptive observational study on patients with acute ischemic stroke treated at the Policlinico A. Gemelli- IRCCS from 1 January 2016 to 31 December 2023.
Key inclusion criteria (4 listed)
- age > 18 years
- Acute ischemic stroke with consistent neurologic and radiologic evidence.
- Performing a CT without contrast and a triphasic CT angiography.
- Execution of mechanical endovascular thrombectomy procedure (whose indication is placed by a neurologist and interventional neuroradiologist).
Key exclusion criteria (1 listed)
- patients lost to follow-up (e.g. back-transfer).
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 thrombectomyAn endovascular thrombectomy is the removal of a thrombus (blood clot) under image guidance. A thrombectomy is most commonly performed for an arterial embolism, which is an arterial blockage often caused by atrial fibrillation, a heart rhythm disorder. | Procedure or surgery | – |
Primary outcome
3 months mRS
Time frame: 3 months
outcome of patients treated by mechanical endovascular thrombectomy evaluated with modified Ranking Scale at 90 days.
1 secondary outcome
Radiological-clinical correlation
Time frame: 3 months
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.
- Background: PubMed 32950754Alexandre AM, Pedicelli A, Valente I, Scarcia L, Giubbolini F, D'Argento F, Lozupone E, Distefano M, Pilato F, Colosimo C. May endovascular thrombectomy without CT perfusion improve clinical outcome? Clin Neurol Neurosurg. 2020 Nov;198:106207. doi: 10.1016/j.clineuro.2020.106207. Epub 2020 Sep 7.
- Background: PubMed 33664106Alexandre AM, Valente I, Consoli A, Piano M, Renieri L, Gabrieli JD, Russo R, Caragliano AA, Ruggiero M, Saletti A, Lazzarotti GA, Pileggi M, Limbucci N, Cosottini M, Cervo A, Viaro F, Vinci SL, Commodaro C, Pilato F, Pedicelli A. Posterior Circulation Endovascular Thrombectomy for Large-Vessel Occlusion: Predictors of Favorable Clinical Outcome and Analysis of First-Pass Effect. AJNR Am J Neuroradiol. 2021 May;42(5):896-903. doi: 10.3174/ajnr.A7023. Epub 2021 Mar 4.
- Background: PubMed 34645097Alexandre AM, Valente I, Frisullo G, Morosetti R, Genovese D, Bartolo A, Gigli R, Rollo C, Scarcia L, Carosi F, Fortunato G, D'Argento F, Calabresi P, Della Marca G, Pedicelli A, Broccolini A. Mechanical thrombectomy in patients with stroke due to large vessel occlusion in the anterior circulation and low baseline NIHSS score. J Integr Neurosci. 2021 Sep 30;20(3):645-650. doi: 10.31083/j.jin2003068.
- Background: PubMed 33256264Pilato F, Silva S, Valente I, Distefano M, Broccolini A, Brunetti V, Caliandro P, Marca GD, Di Iorio R, Frisullo G, Monforte M, Morosetti R, Piano C, Calandrelli R, Capone F, Alexandre A, Pedicelli A, Colosimo C, Caricato A. Predicting Factors of Functional Outcome in Patients with Acute Ischemic Stroke Admitted to Neuro-Intensive Care Unit-A Prospective Cohort Study. Brain Sci. 2020 Nov 26;10(12):911. doi: 10.3390/brainsci10120911.
- Background: PubMed 33454704Di Iorio R, Pilato F, Valente I, Laurienzo A, Gaudino S, Frisullo G, Profice P, Cottonaro S, Alexandre A, Caliandro P, Morosetti R, Lozupone E, D'Argento F, Pedicelli A, Colosimo C, Calabresi P, Della Marca G, Broccolini A. Role of Favorable Perfusion Imaging in Predicting the Outcome of Patients with Acute Ischemic Stroke due to Large Vessel Occlusion Undergoing Effective Thrombectomy: A Single-Center Study. Cerebrovasc Dis Extra. 2021;11(1):1-8. doi: 10.1159/000513025. Epub 2021 Jan 15.
- Background: PubMed 34947955Alexandre AM, Valente I, Consoli A, Trombatore P, Scarcia L, Piano M, Limbucci N, Gabrieli JD, Russo R, Caragliano AA, Ruggiero M, Saletti A, Lazzarotti GA, Pileggi M, Cosottini M, Pilato F, Slomka A, Colo F, Giubbolini F, Frisullo G, Della Marca G, Broccolini A, Pedicelli A. Posterior Circulation Endovascular Thrombectomy for Large Vessels Occlusion in Patients Presenting with NIHSS Score </= 10. Life (Basel). 2021 Dec 17;11(12):1423. doi: 10.3390/life11121423.
- Background: PubMed 36223995Alexandre AM, Colo F, Brunetti V, Valente I, Frisullo G, Pedicelli A, Scarcia L, Rollo C, Falcou A, Milonia L, Andrighetti M, Piano M, Macera A, Commodaro C, Ruggiero M, Da Ros V, Bellini L, Lazzarotti GA, Cosottini M, Caragliano AA, Vinci SL, Gabrieli JD, Causin F, Panni P, Roveri L, Limbucci N, Arba F, Pileggi M, Bianco G, Romano DG, Diana F, Semeraro V, Burdi N, Ganimede MP, Lozupone E, Fasano A, Lafe E, Cavallini A, Russo R, Bergui M, Calabresi P, Della Marca G, Broccolini A. Mechanical thrombectomy in minor stroke due to isolated M2 occlusion: a multicenter retrospective matched analysis. J Neurointerv Surg. 2023 Nov;15(e2):e198-e203. doi: 10.1136/jnis-2022-019557. Epub 2022 Oct 12.
- Background: PubMed 34933250Pilato F, Valente I, Calandrelli R, Alexandre A, Arena V, Dell'Aquila M, Broccolini A, Della Marca G, Morosetti R, Frisullo G, Brunetti V, Distefano M, Pedicelli A, Colosimo C, Di Lazzaro V. Clot evaluation and distal embolization risk during mechanical thrombectomy in anterior circulation stroke. J Neurol Sci. 2022 Jan 15;432:120087. doi: 10.1016/j.jns.2021.120087. Epub 2021 Dec 14.
- Background: PubMed 34843020Alexandre AM, Valente I, Pedicelli A, Pezzullo AM, Colo F, Scarcia L, Romi A, Piano M, Macera A, Gabrieli JD, Cester G, Caragliano AA, Vinci SL, Ruggiero M, Commodaro C, Saletti A, Lazzarotti GA, Cosottini M, Da Ros V, Bellini L, Lozupone E, Paladini A, Brunetti V, Morosetti R, Frisullo G, Calabresi P, Marca GD, Broccolini A. Mechanical thrombectomy in acute ischemic stroke due to large vessel occlusion in the anterior circulation and low baseline National Institute of Health Stroke Scale score: a multicenter retrospective matched analysis. Neurol Sci. 2022 May;43(5):3105-3112. doi: 10.1007/s10072-021-05771-5. Epub 2021 Nov 29.
- 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 Stroke and Endovascular Thrombectomy, 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 (+390630151, andrea.alexandre@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 months mRS (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708079, which also lists 9 linked publications.
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.