Acute Ischemic StrokeFrameLPNCT05539404
Evaluate Endovascular Treatment of Large Ischemic Stroke With Substantial Penumbra.
A study testing Endovascular treatment in addition of best medical treatment. in people with Acute Ischemic Stroke, run by University Hospital, Toulouse at 9 sites in France.
Trial summary
Large cerebral infarctions are frequent and associated with a poor outcome. Previous cohort studies results suggest that patients with an acute ischemic stroke with large core and substantial penumbra on perfusion imaging benefit from EVT while those with no salvageable ischemic tissue did not. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Endovascular treatment in addition of best medical treatment.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 9 sitesFrance
- Study dates
- 2 Nov 2022to 18 Apr 2023
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients experiencing an acute ischemic stroke related to an anterior proximal large vessel occlusion (ICA/M1/Tandem) on MR or CT-angiography evolving for less than 24 hours from last known to be well. For patients experiencing a wake-up stroke or a stroke of unknown onset the mid-point between last seen well and symptoms discovery + the delay between symptoms discovery to randomization, will be used to calculate the delay between symptom onset to randomization.
- On baseline imaging (MRI Diffusion Weighted Imaging/Perfusion Weighted Imaging or CTP) L.P. profile defined by a Large Core > 70 mL, and a MM ratio>1.4 using RAPID software.
- Delay between end of imaging and randomization <90 min.
- Expected delay between end of imaging and femoral puncture < 60 min
- Best medical treatment including IV thrombolysis if indicated
- Surrogate decision maker's consent or emergency inclusion form.
- Affiliated person or beneficiary of a social security scheme.
Who cannot join
- Pre-Stroke mRS >1.
- Other serious advanced or terminal illness or life expectancy is estimated to be less than 6 months.
- Pre-existing medical, neurological or psychiatric condition that would confound the neurological or functional evaluation.
- Pregnancy and breastfeeding
- Inability to undergo contrast brain perfusion MR or CT.
- Technically inadequate perfusion imaging precluding L.P. profile assessment
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- Occlusion in multiple proximal vascular site territories (eg. bilateral anterior circulation occlusion or anterior + posterior circulation occlusions).
- Known allergy to iodine precluding EVT.
- Vessel anatomy or tortuosity precluding EVT.
- Patient under judicial protection.
- Participation in another interventional or therapeutic study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hôpital Pellegrin
Bordeaux, 33076
University Hospital of Lille Hôpital Roger Salengro
Lille, 590370
University Hospital of Limoges Hôpital Dupuytren 1
Limoges, 87042
University Hospital of Montpellier Hôpital Gui de Chauliac
Montpellier, 34295
University Hospital of Nancy (CHRU) Hôpital central
Nancy, 54000
Fondation Adolphe de Rothschild Hospital
Paris, 75019
University Hospital Pitié-Salpétrière AP-HP
Paris, 75651
Foch Hospital Centre
Suresnes, 92150
University Hospital Toulouse
Toulouse, 31059
About this study
Official title: French Acute Randomized Controlled Trial Using Multimodal Imaging for Endovascular Treatment of Patients With Large Cerebral Infarction With Substantial Penumbra up to 24 Hours
Large cerebral infarctions are frequent and associated with a poor outcome. Previous cohort studies results suggest that patients with an acute ischemic stroke with large core and substantial penumbra on perfusion imaging benefit from EVT while those with no salvageable ischemic tissue did not. The Investigator aim to demonstrate in a randomized controlled trials (RCT) that EVT (Endo Vascular Treatment) in addition to BMT (Best Medical Treatment) increases the rate of functional recovery (mRS 0-2) at 3 months in patients with a LVO-related AIS with a large core and substantial penumbra evolving for less than 24hrs
Read the detailed description
The reperfusion of salvageable ischemic tissue (penumbra) to improve functional recovery is the aim of the endovascular treatment (EVT) of acute ischemic stroke (AIS) complicating large cerebral vessel occlusion (LVO). Downstream of an LVO, imaging profiles are highly variable ranging from a large completed infarction within 2 hrs to a small core and a large mismatch at 24 hrs after onset . A large core is typically associated with a poor prognosis and was a common exclusion criterion from the RCTs that demonstrated the efficacy of EVT for LVO related AIS . However the investigator recently reported that AIS with a large core 1- represent 20% of the LVO-related AIS scanned within 6 hours after onset 2- Up to 50% had a MM on perfusion imaging and 3- EVT increases the rate of functional recovery in patients with a large core over BMT only in the subgroup of patients with a MM (Mismatch) on baseline imaging .
One hundred and eighty patients experiencing an LVO-related AIS within 24 hours after last known well, with a documented large core (>70mL) and a MM on baseline imaging will be randomized (1:1) to undergo EVT+BMT vs. BMT in a multicenter, randomized, controlled, open-label, in parallel groups with blinded endpoint evaluation (PROBE design) superiority trial.
Study participants will be followed up for 6 months. Participants will be treated and managed in acute stroke units by certified stroke neurologists and neurointerventionists according to the current recommendations . Neurological deficit will be assessed using the NIH Stroke Scale (NIHSS) by certified investigators.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Endovascular treatment in addition of best medical treatment.
- Keywords
- Acute ischemic stroke, large stroke, Multimodal brain imaging, Thrombectomy, endovascular treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment in addition of best medical treatment.Procedure or surgery
Also called Mechanical thrombectomy
Endovascular treatment (EVT) of acute ischemic stroke (AIS) related to an anterior large cerebral vessel occlusion (LVO)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Strategy Group | Experimental | endovascular treatment in addition to best medical treatment Receives: Procedure: Endovascular treatment in addition of best medical treatment. |
| Control Strategy Group | No intervention | best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients achieving a functional recovery defined by modified Rankin Scale 0-2 at 3 months
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, done by a certified rater, blinded of the arm of the randomization
Measured: 3 months
Secondary outcomes (5)
modified Rankin Scale
Rate of patients with Modified Rankin Scale of 0-2 , rate of patients with Modified Rankin Scale 0-3 and Global disability assessed by overall distribution of the Modified Rankin Scale (shift analysis combining scores 5 and 6)
Measured: 3 and 6 months
National Institute of Health Scale
Rate of patients achieving an early neurological improvement National Institutes of Health Stroke Scale (NIHSS) >or=8 reduction from baseline to day 1 or National Institutes of Health Stroke Scale (NIHSS) =0-1 at day 1
Measured: Day 1
Modified Thrombolysis in Cerebral Infarction score
Rate of successful reperfusion in the EndoVascular Treatment+Best medical treatment arm defined by a mTICI ( Modified Thrombolysis in Cerebral Infarction) 2bc3 score
Measured: Day 1
mortality rate
Number of subject who die during the study participation in each arm.
Measured: 3 and 6 months
Symptomatic Hemorrhagic Transformation
Symptomatic hemorrhagic transformation is defined by an intra cerebral hemorrhage (European Cooperative Acute Stroke Study III classification " ECASS III ") associated with a 4 or more point increase on the National Institute of Health " NIH " Stroke Scale by comparison with NIH Stroke Scale immediately predeterioration.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start2 Nov 2022
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Why it stopped: Study ends for scientific reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc OLIVOT, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539404
- Sponsor's protocol ID
- RC31/21/0336
- Other IDs
- 2021-A03139-32
- Acronym
- FrameLP
- Status last verified
- Jun 2023
- First submitted
- 11 Jul 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Acute Randomized Controlled Trial Using Multimodal Imaging for Endovascular Treatment of Patients With Large Cerebral Infarction With Substantial Penumbra up to 24 Hours
- ClinicalTrials.gov ID
- NCT05539404
- Acronym / sponsor ID
- FrameLP / RC31/21/0336
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, large stroke, Multimodal brain imaging, Thrombectomy, endovascular treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ends for scientific reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 14 Sep 2022 (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.
Large cerebral infarctions are frequent and associated with a poor outcome. Previous cohort studies results suggest that patients with an acute ischemic stroke with large core and substantial penumbra on perfusion imaging benefit from EVT while those with no salvageable ischemic tissue did not. The Investigator aim to demonstrate in a randomized controlled trials (RCT) that EVT (Endo Vascular Treatment) in addition to BMT (Best Medical Treatment) increases the rate of functional recovery (mRS 0-2) at 3 months in patients with a LVO-related AIS with a large core and substantial penumbra evolving for less than 24hrs
Detailed description
The reperfusion of salvageable ischemic tissue (penumbra) to improve functional recovery is the aim of the endovascular treatment (EVT) of acute ischemic stroke (AIS) complicating large cerebral vessel occlusion (LVO). Downstream of an LVO, imaging profiles are highly variable ranging from a large completed infarction within 2 hrs to a small core and a large mismatch at 24 hrs after onset . A large core is typically associated with a poor prognosis and was a common exclusion criterion from the RCTs that demonstrated the efficacy of EVT for LVO related AIS . However the investigator recently reported that AIS with a large core 1- represent 20% of the LVO-related AIS scanned within 6 hours after onset 2- Up to 50% had a MM on perfusion imaging and 3- EVT increases the rate of functional recovery in patients with a large core over BMT only in the subgroup of patients with a MM (Mismatch) on baseline imaging .
One hundred and eighty patients experiencing an LVO-related AIS within 24 hours after last known well, with a documented large core (>70mL) and a MM on baseline imaging will be randomized (1:1) to undergo EVT+BMT vs. BMT in a multicenter, randomized, controlled, open-label, in parallel groups with blinded endpoint evaluation (PROBE design) superiority trial.
Study participants will be followed up for 6 months. Participants will be treated and managed in acute stroke units by certified stroke neurologists and neurointerventionists according to the current recommendations . Neurological deficit will be assessed using the NIH Stroke Scale (NIHSS) by certified investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Strategy Group | Experimental | Procedure: Endovascular treatment in addition of best medical treatment.endovascular treatment in addition to best medical treatment |
| Control Strategy Group | No intervention | –best medical treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients experiencing an acute ischemic stroke related to an anterior proximal large vessel occlusion (ICA/M1/Tandem) on MR or CT-angiography evolving for less than 24 hours from last known to be well. For patients experiencing a wake-up stroke or a stroke of unknown onset the mid-point between last seen well and symptoms discovery + the delay between symptoms discovery to randomization, will be used to calculate the delay between symptom onset to randomization.
- On baseline imaging (MRI Diffusion Weighted Imaging/Perfusion Weighted Imaging or CTP) L.P. profile defined by a Large Core > 70 mL, and a MM ratio>1.4 using RAPID software.
- Delay between end of imaging and randomization <90 min.
- Expected delay between end of imaging and femoral puncture < 60 min
- Best medical treatment including IV thrombolysis if indicated
Key exclusion criteria (11 listed)
- Pre-Stroke mRS >1.
- Other serious advanced or terminal illness or life expectancy is estimated to be less than 6 months.
- Pre-existing medical, neurological or psychiatric condition that would confound the neurological or functional evaluation.
- Pregnancy and breastfeeding
- Inability to undergo contrast brain perfusion MR or CT.
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 treatment in addition of best medical treatment.Also: Mechanical thrombectomyEndovascular treatment (EVT) of acute ischemic stroke (AIS) related to an anterior large cerebral vessel occlusion (LVO) | Procedure or surgery | Experimental Strategy Group |
Primary outcome
Rate of patients achieving a functional recovery defined by modified Rankin Scale 0-2 at 3 months
Time frame: 3 months
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, done by a certified rater, blinded of the arm of the randomization
5 secondary outcomes
modified Rankin Scale
Time frame: 3 and 6 months
National Institute of Health Scale
Time frame: Day 1
Modified Thrombolysis in Cerebral Infarction score
Time frame: Day 1
mortality rate
Time frame: 3 and 6 months
Symptomatic Hemorrhagic Transformation
Time frame: 36 hours
Results and safety
The study was stopped early (reason given: Study ends for scientific reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 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.
Jean-Marc OLIVOT, MD PhD principal investigator
University Hospital, Toulouse
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment in addition of best medical treatment. in people with Acute Ischemic Stroke, run by University Hospital, Toulouse at 9 sites 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 was stopped early (reason given: Study ends for scientific reasons). Results are not available in the source record.
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?
Rate of patients achieving a functional recovery defined by modified Rankin Scale 0-2 at 3 months (time frame: 3 months). 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 9 Jun 2023.