Ischemic StrokeACAPULCONCT04823481
Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)
An observational study of Ischemic Stroke and Thrombi, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Ischemic Stroke, Thrombi
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke who presented within 6 hours of stroke symptoms onset with isolated occlusion of the anterior or the posterior artery.
Who may be able to join
- Age ≥ 18 and < 96
- Clinical signs consistent with acute ischemic stroke
- Patients who presented within 6 hours of stroke symptoms onset
- Isolated occlusion of the anterior or the posterior artery
Who cannot join
- Administration of recanalization treatment before hospital admission
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone or in addition with IT. Therefore, observational studies are needed to understand the clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective observational study aims to highlight potential benefits of MT in those patients to improve their management and to propose targeted therapies in the future.
- Conditions
- Ischemic Stroke, Thrombi
- Medical subject headings
- Ischemic Stroke, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinico-radiological evolution of IS patients with isolated occlusion of the anterior or posterior cerebral artery.
Good Neurological Condition Good neurological outcome (GNO) at 3 months will defined using the modified Rankin Scale (mRS). A normal/near normal outcome after procedure is associated with a mRS Scale score = 0-1 and severe disability/death is associated with a mRS Scale score = 5-6
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Seners, MD,PhD, Principal investigator, Hôpital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823481
- Sponsor's protocol ID
- CE_20210126_8_PSS
- Acronym
- ACAPULCO
- Status last verified
- Dec 2022
- First submitted
- 26 Mar 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)
- ClinicalTrials.gov ID
- NCT04823481
- Acronym / sponsor ID
- ACAPULCO / CE_20210126_8_PSS
- Conditions
- Ischemic Stroke, Thrombi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Mar 2021 (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.
Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone or in addition with IT. Therefore, observational studies are needed to understand the clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective observational study aims to highlight potential benefits of MT in those patients to improve their management and to propose targeted therapies in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke who presented within 6 hours of stroke symptoms onset with isolated occlusion of the anterior or the posterior artery.
Key inclusion criteria (4 listed)
- Age ≥ 18 and < 96
- Clinical signs consistent with acute ischemic stroke
- Patients who presented within 6 hours of stroke symptoms onset
- Isolated occlusion of the anterior or the posterior artery
Key exclusion criteria (1 listed)
- Administration of recanalization treatment before hospital admission
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
Clinico-radiological evolution of IS patients with isolated occlusion of the anterior or posterior cerebral artery.
Time frame: 90 days
Good Neurological Condition Good neurological outcome (GNO) at 3 months will defined using the modified Rankin Scale (mRS). A normal/near normal outcome after procedure is associated with a mRS Scale score = 0-1 and severe disability/death is associated with a mRS Scale score = 5-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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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.
Pierre Seners, MD,PhD principal investigator
Hôpital Fondation Adolphe de Rothschild
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 Ischemic Stroke and Thrombi, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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: finished, as of the sponsor's last update on 12 Dec 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinico-radiological evolution of IS patients with isolated occlusion of the anterior or posterior cerebral artery. (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 12 Dec 2022.