Acute StrokeREPAIR-FCNCT03451903
Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?
An observational study of Acute Stroke, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
This study aims to identify factors influencing the time span and success of reperfusion after a mechanical thrombectomy in the acute phase of cerebral infarction, and in particular the effect of intra-venous thrombolysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Actilyse and Mechanical thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Feb 2018
- 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: Patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon. Data are prospectively collected in the Franche-Comté Stroke Registry.
Who may be able to join
- acute phase of cerebral infarction
- all patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon
- from 1st January 2015 to 31st December 2016
Who cannot join
- Patients whose procedures were interrupted (puncture failure, catheterisation of the common or internal carotid artery failure)
- Patients whose arteries were recanalised during the diagnostic arteriography
About this study
This study aims to identify factors influencing the time span and success of reperfusion after a mechanical thrombectomy in the acute phase of cerebral infarction, and in particular the effect of intra-venous thrombolysis.
Read the detailed description
Mechanical thrombectomy (MT), associated with standard IV thrombolysis (IVT) treatment, is effective during the acute phase of cerebral infarction with proximal occlusion of the anterior circulation in reducing disability at three months. MT-only treatment has only been assessed retrospectively in subgroups of controlled studies, with a significant difference in favour of the treatment. These results have led to a discussion about the benefits of MT without IVT in cases of proximal occlusion or carotid terminus occlusion. Recent data are in favour of a better prognosis for patients benefiting from a combined procedure. The impact of IVT on the implementation of MT is widely disputed, in particular the speed of execution, which could be enhanced by IVT. The factors influencing the time span and success of reperfusion after an MT are still not well-known, IVT in particular. The investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.
The investigators carried out a retrospective study based on data gathered prospectively by the Franche-Comté Stroke Registry. The investigators also considered other factors which could have affected the duration of the procedure or the rate of satisfactory revascularisation, including location of infarct, thrombus size and stroke aetiology.
Hypothesis: the investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.
- Conditions
- Acute Stroke
- Being tested
- Actilyse, Mechanical thrombectomy
- Keywords
- stroke, thrombectomy, procedure time, revascularisation, thrombolytic therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActilyseDrug
Also called rtPA
Actilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction.
Mechanical thrombectomyProcedure or surgery
Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical thrombectomy group | Patients with acute stroke treated by mechanical thrombectomy. Receives: Procedure: Mechanical thrombectomy | |
| Combined procedure group | Patients with acute stroke treated by intravenous thrombolysis (with actilyse) and mechanical thrombectomy. Receives: Drug: Actilyse; Procedure: Mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the procedure
It is the period of time between when the artery is punctured and when the first image from the first cerebral angiographic test is acquired after revascularisation, which is used to calculate the rate of revascularisation.
Measured: From the beginning of mechanical thrombectomy to the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2016
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Bonnet, MD, Principal investigator, J Minjoz Besancon university Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451903
- Sponsor's protocol ID
- P/2017/348
- Acronym
- REPAIR-FC
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 29 Mar 2018
- 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 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?
- ClinicalTrials.gov ID
- NCT03451903
- Acronym / sponsor ID
- REPAIR-FC / P/2017/348
- Conditions
- Acute Stroke
- Keywords
- stroke, thrombectomy, procedure time, revascularisation, thrombolytic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 2 Mar 2018 (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.
This study aims to identify factors influencing the time span and success of reperfusion after a mechanical thrombectomy in the acute phase of cerebral infarction, and in particular the effect of intra-venous thrombolysis.
Detailed description
Mechanical thrombectomy (MT), associated with standard IV thrombolysis (IVT) treatment, is effective during the acute phase of cerebral infarction with proximal occlusion of the anterior circulation in reducing disability at three months. MT-only treatment has only been assessed retrospectively in subgroups of controlled studies, with a significant difference in favour of the treatment. These results have led to a discussion about the benefits of MT without IVT in cases of proximal occlusion or carotid terminus occlusion. Recent data are in favour of a better prognosis for patients benefiting from a combined procedure. The impact of IVT on the implementation of MT is widely disputed, in particular the speed of execution, which could be enhanced by IVT. The factors influencing the time span and success of reperfusion after an MT are still not well-known, IVT in particular. The investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.
The investigators carried out a retrospective study based on data gathered prospectively by the Franche-Comté Stroke Registry. The investigators also considered other factors which could have affected the duration of the procedure or the rate of satisfactory revascularisation, including location of infarct, thrombus size and stroke aetiology.
Hypothesis: the investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical thrombectomy group | – | Procedure: Mechanical thrombectomyPatients with acute stroke treated by mechanical thrombectomy. |
| Combined procedure group | – | Drug: Actilyse, Procedure: Mechanical thrombectomyPatients with acute stroke treated by intravenous thrombolysis (with actilyse) and mechanical thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon. Data are prospectively collected in the Franche-Comté Stroke Registry.
Key inclusion criteria (3 listed)
- acute phase of cerebral infarction
- all patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon
- from 1st January 2015 to 31st December 2016
Key exclusion criteria (2 listed)
- Patients whose procedures were interrupted (puncture failure, catheterisation of the common or internal carotid artery failure)
- Patients whose arteries were recanalised during the diagnostic arteriography
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 |
|---|---|---|
| ActilyseAlso: rtPAActilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction. | Drug | Combined procedure group |
| Mechanical thrombectomyMechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain. | Procedure or surgery | Combined procedure group, Mechanical thrombectomy group |
Primary outcome
Duration of the procedure
Time frame: From the beginning of mechanical thrombectomy to the end of the procedure.
It is the period of time between when the artery is punctured and when the first image from the first cerebral angiographic test is acquired after revascularisation, which is used to calculate the rate of revascularisation.
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 29 Mar 2018.
- 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.
Louise Bonnet, MD principal investigator
J Minjoz Besancon university Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Centre Hospitalier Universitaire de Besancon.
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 2 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Duration of the procedure (time frame: From the beginning of mechanical thrombectomy to the end of the procedure.). 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 29 Mar 2018.