Acute Ischemic Stroke Due to Medium-vessel-occlusionDIVArétroNCT05809921
Dual IntraVenous Thrombolysis Approach (DIVA) in Patients With Medium-vessel-occlusion Strokes: a Retrospective Study
An observational study of Acute Ischemic Stroke Due to Medium-vessel-occlusion, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this study (Dual IV thrombolysis Approach (DIVA) study) is to assess a new medical strategy for Medium-vessel-occlusion (MeVO) strokes, based on a second IV thrombolysis with tenecteplase (TNK) for persistent intracranial occlusion on MRI 1-2 hours after standard alteplase infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke Due to Medium-vessel-occlusion
- What is being tested?
- alteplase and Alteplase + possible complementary IVT with tenecteplase
- Type of treatment
- Injection or infusion
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2023to 13 Sep 2023
- 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: This is a bicentric retrospective study: Sud-Francilien Hospital (SFH), Corbeil-Essonnes, France for the DIVA cohort and Bordeaux University Hospital (BUH) for the standard treatment with alteplase alone cohort, based on stroke registries prospectively gathered. From March 2014 to November 2018, consecutive patients in SFH and BUH with acute ischemic stroke (AIS) due to distal occlusion assessed on brain MRI who fulfilled the inclusion/exclusion criteria were included in this retrospective analysis.
Who may be able to join
- For the SIS cohort :
- Age≥ 18 years
- Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on initial MRI associated with distal arterial occlusion as defined below:
- A distal occlusion of the M2 segment of the middle cerebral artery (MCA)
- Occlusion (regardless of location) of a non-dominant M2 branch of the MCA
- Occlusion of the M3 segment of the MCA.
Show all 46Show fewer
- Occlusion of the A2 or A3 segment of the anterior cerebral artery (ACA)
- Occlusion of the P2 or P3 branch of the posterior cerebral artery (PCA).
- A proximal M2-MCA or proximal P1-PCA occlusion may also be included if not eligible for mechanical thrombectomy, especially if the initial NIHSS score is low (<5).
- IVT by ALT within 4h30 after onset of symptoms,
- MRI performed 24h after IVT
- For the DIS cohort :
- Age≥ 18 years
- Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on baseline MRI associated with distal arterial occlusion as defined below:
- A distal occlusion of the M2 segment of the middle cerebral artery (MCA)
- Occlusion (regardless of location) of a non-dominant M2 branch of the MCA
- Occlusion of the M3 segment of the MCA.
- Occlusion of the A2 or A3 segment of the anterior cerebral artery (ACA)
- Occlusion of the P2 or P3 branch of the posterior cerebral artery (PCA).
- A proximal M2-MCA or proximal P1-PCA occlusion may also be included if not eligible for mechanical thrombectomy, especially if the initial NIHSS score is low (<6).
- IVT by ALT within 4h30 after onset of symptoms
- Repeat MRI performed 1-2h after IVT (MRI-2)
- Brain MRI performed 24h after IVT
- For the SIS cohort :
- Age≥ 18 years
- Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on initial MRI associated with distal arterial occlusion as defined below:
- A distal occlusion of the M2 segment of the middle cerebral artery (MCA)
- Occlusion (regardless of location) of a non-dominant M2 branch of the MCA
- Occlusion of the M3 segment of the MCA.
- Occlusion of the A2 or A3 segment of the anterior cerebral artery (ACA)
- Occlusion of the P2 or P3 branch of the posterior cerebral artery (PCA).
- A proximal M2-MCA or proximal P1-PCA occlusion may also be included if not eligible for mechanical thrombectomy, especially if the initial NIHSS score is low (<5).
- IVT by ALT within 4h30 after onset of symptoms,
- MRI performed 24h after IVT
- For the DIS cohort :
- Age≥ 18 years
- Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on baseline MRI associated with distal arterial occlusion as defined below:
- A distal occlusion of the M2 segment of the middle cerebral artery (MCA)
- Occlusion (regardless of location) of a non-dominant M2 branch of the MCA
- Occlusion of the M3 segment of the MCA.
- Occlusion of the A2 or A3 segment of the anterior cerebral artery (ACA)
- Occlusion of the P2 or P3 branch of the posterior cerebral artery (PCA).
- A proximal M2-MCA or proximal P1-PCA occlusion may also be included if not eligible for mechanical thrombectomy, especially if the initial NIHSS score is low (<6).
- IVT by ALT within 4h30 after onset of symptoms
- Repeat MRI performed 1-2h after IVT (MRI-2)
- Brain MRI performed 24h after IVT
Who cannot join
- For SIS and DIS cohort :
- Patients informed of the study who objected to the collection of their data.
- Patients with >5 microbleeds; diffuse or focal cortical siderosis; severe leukoaraiosis (Fazekas score 3/3); any coagulopathy type, including a baseline international normalized ratio (INR) >1.3, were excluded for the SIS and DIS cohort.
- Exclusion criteria for a complementary IVT with TNK in the DIS cohort:
- (Patients will be included in the DIS cohort but will not receive a secondary IVT with TNK ) Brain exclusion criteria on MRI-2: Early recanalization, acute lesion visible on FLAIR sequence, new cerebral/subarachnoid hemorrhage of any type or size.
- Significant extracerebral bleeding, such as abundant gingivorrhagia, epistaxis, multiple/diffuse ecchymoses or macroscopic hematuria.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study (Dual IV thrombolysis Approach (DIVA) study) is to assess a new medical strategy for Medium-vessel-occlusion (MeVO) strokes, based on a second IV thrombolysis with tenecteplase (TNK) for persistent intracranial occlusion on MRI 1-2 hours after standard alteplase infusion. The DIVA-study results were compared with a similar cohort of MeVO strokes patients treated with standard therapy (single IVT with alteplase) during the same timeframe in another stroke unit.
Read the detailed description
MeVO strokes account for 25-40% of all acute ischemic stroke (AIS). In a recent study, less than 1/3 of MeVO strokes patients had a so-called "minor stroke" (National Institute of Health Stroke score (NIHSS)<6), thereby emphasizing that strategically located MeVO strokes can be debilitating. Therefore it is crucial to achieve early recanalization, which is strongly associated with excellent outcomes. However, standard medical treatment (that is to say, a single intravenous thrombolysis (IVT) with alteplase 0.9mg/kg) resulted in early (60-120 min) and late (24-36 hours) recanalizations of MeVO in only 30% and 64% respectively. As a consequence, and in line with a recent study, almost 40% of these patients were functionally dependent at 3 months (modified Rankin Score>2) despite IVT.
Because randomized clinical trials on EVT enrolled only limited numbers of patients with distal occlusions, mostly proximal M2 segment-middle cerebral artery occlusions, EVT has not yet been established as standard-of-care for MeVO strokes, and owing to the fragility of these small intracranial arteries, safety of EVT for MeVO is questionable and randomized trials are ongoing.
In comparison with EVT, a purely chemical strategy for MeVO strokes would be far less human-resource demanding, cheaper and feasible almost everywhere. In a previous study, the investigators showed results in favor of a high rate of recanalization at 24h in patients with stroke due to proximal occlusion with a dual IVT strategy (additional IVT with TNK in patients with persistent occlusion 1h after alteplase IVT), and this with a low hemorrhagic risk. Distal arterial occlusions are at lower hemorrhagic risk than proximal occlusions because volume infarcts are smaller, and because they spare basal ganglia, a critical location for massive hemorrhagic transformation of AIS. Moreover, patients could be carefully pre-selected with the initial MRI evaluation, allowing exclusion of patients with severe microangiopathy or amyloid angiopathy.
From March 1, 2014, to November 31, 2018, the investigators proposed a dual-IVT strategy (DIS) to patients admitted to the CHSF-Stroke Unit for MeVO-associated AIS eligible for IVT but not suitable for EVT. They were given a repeat MRI 1-2h after alteplase, 0.9 mg/kg, maximum 90 mg (IVT-1). If no recanalization was obtained and in the absence of exclusion criteria (acute lesion visible on FLAIR sequence, new cerebral/subarachnoid hemorrhage; significant extracerebral bleeding), a second IVT with TNK, 0.25 mg/kg, maximum 25 mg) (IVT-2) was given. The whole procedure was done within 6h of symptom onset.
During the same period, Bordeaux University Hospital-Stroke Unit constituted a cohort of consecutive patients with MeVO-AIS treated with conventional single-IVT strategy (SIS) using alteplase.
DIS- and SIS-cohort data were collected prospectively and the comparison was retrospective.
The pre-specified primary efficacy endpoint was successful recanalization assessed on MRI at 24h. The pre-specified primary safety endpoint was severe bleeding: symptomatic intracranial hemorrhage or major systemic bleeding during the first 36 hours. Secondary endpoints were: early neurological improvement at 24h, early complete neurological recovery at 24h and excellent (modified Rankin scale (mRS) 0-1) and good (mRS 0-2) clinical outcomes at 3 months.
- Being tested
- alteplase, Alteplase + possible complementary IVT with tenecteplase
- Keywords
- Acute stroke, Medium-vessel occlusion, Thrombolysis, Tenecteplase
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alteplaseDrug
Intravenous thrombolysis with alteplase (0.9 mg/kg, maximum 90 mg) with 10% of the dose given as a bolus followed by an infusion lasting 60 minutes.
Alteplase + possible complementary IVT with tenecteplaseDrug
Intravenous thrombolysis with alteplase (0.9 mg/kg, maximum 90 mg, with 10% of the dose given as a bolus followed by an infusion lasting 60 minutes) and depending on the MRI-2 results, an additional IVT with tenecteplase (0.25mg/kg, maximum 25 mg, with 100% of the dose given as a bolus) could be given in case of persistent occlusion and with no contraindication according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Single-IVT strategy (SIS) cohort | The SIS cohort included patients with MeVO strokes who received a single conventional alteplase IVT (IVT-1). Receives: Drug: alteplase | |
| Dual-IVT strategy (DIS) cohort | The DIS cohort included patients with alteplase-treated MeVO strokes for whom a repeat MRI (MRI-2) was planned 1-2h after alteplase IVT (IVT-1) to discuss a possible complementary IVT with tenecteplase (TNK-IVT-2).
Patients could be in the following situations: already recanalized at 1-2h post-alteplase IVT-1, persistent occlusion treated with TNK-IVT-2 or persistent occlusion but additional IVT contraindicated according to the study protocol. Receives: Drug: Alteplase + possible complementary IVT with tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization rate assed on the control MRI at 24h (MRI-3) based on the Arterial Occlusive Lesion (AOL) score
Recanalization rate at 24h was evaluated on MRI-3 using the AOL scale. This scale was adapted for very distal occlusions which are not always clearly visible on magnetic resonance angiography (MRA). In these cases, AOL scale-score was based on gradient echo-sequences (GE):
If occlusion visible on MRI:
- no recanalization: AOL- 0, 1, 2a
- successful recanalization : AOL-2b or 3
If occlusion not visible on MRA but thrombus visible on GE:
- no recanalization : AOL-0 (unchanged thrombus) or AOL-1/AOL-2a (slight down-stream migration ore size reduction of the thrombus)
- successful recanalization : AOL-2b (residual distal thrombus), or AOL-3 (complete thrombus disappearance).
Measured: at 24 hours
Secondary outcomes (4)
Symptomatic intracranial Hemorrhages (sICH)
Rates of sICH at 24h (on MRI-3) according to the SITS-MOST and ECASS II criteria.
Measured: at 24 hours
NIHSS
Clinical severity based on NIHSS assessment Delta NIHSS : NIHSS-H0 minus NIHSS-H24 Based on NIHSS assessment : baseline, at 24h. Delta NIHSS : NIHSS-H0 minus NIHSS-H24
Measured: at 24 hours
modified Rankin Scale score (mRS)
Functional independency
Measured: at 3 months
mRS 6
death
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start17 May 2023
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke Due to Medium-vessel-occlusionStudies of the same condition, open and under way.
- 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
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809921
- Sponsor's protocol ID
- 2023/0002
- Acronym
- DIVArétro
- Status last verified
- Nov 2023
- First submitted
- 30 Mar 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chausson N, Olindo S, Laborne FX, Aghasaryan M, Renou P, Soumah D, Debruxelles S, Altarcha T, Poli M, L'Hermitte Y, Sagnier S, Toudou-Daouda M, Aminou-Tassiou NR, Bentamra L, Benmoussa N, Alecu C, Imbernon C, Smadja L, Ouanounou G, Rouanet F, Sibon I, Smadja D. Second-dose intravenous thrombolysis with tenecteplase in alteplase-resistant medium-vessel-occlusion strokes: A retrospective and comparative study. Eur Stroke J. 2024 Dec;9(4):943-951. doi: 10.1177/23969873241254936. Epub 2024 Jun 3.
PubMed 38829011
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual IntraVenous Thrombolysis Approach (DIVA) in Patients With Medium-vessel-occlusion Strokes: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05809921
- Acronym / sponsor ID
- DIVArétro / 2023/0002
- Keywords
- Acute stroke, Medium-vessel occlusion, Thrombolysis, Tenecteplase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 12 Apr 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.
The purpose of this study (Dual IV thrombolysis Approach (DIVA) study) is to assess a new medical strategy for Medium-vessel-occlusion (MeVO) strokes, based on a second IV thrombolysis with tenecteplase (TNK) for persistent intracranial occlusion on MRI 1-2 hours after standard alteplase infusion. The DIVA-study results were compared with a similar cohort of MeVO strokes patients treated with standard therapy (single IVT with alteplase) during the same timeframe in another stroke unit.
Detailed description
MeVO strokes account for 25-40% of all acute ischemic stroke (AIS). In a recent study, less than 1/3 of MeVO strokes patients had a so-called "minor stroke" (National Institute of Health Stroke score (NIHSS)<6), thereby emphasizing that strategically located MeVO strokes can be debilitating. Therefore it is crucial to achieve early recanalization, which is strongly associated with excellent outcomes. However, standard medical treatment (that is to say, a single intravenous thrombolysis (IVT) with alteplase 0.9mg/kg) resulted in early (60-120 min) and late (24-36 hours) recanalizations of MeVO in only 30% and 64% respectively. As a consequence, and in line with a recent study, almost 40% of these patients were functionally dependent at 3 months (modified Rankin Score>2) despite IVT.
Because randomized clinical trials on EVT enrolled only limited numbers of patients with distal occlusions, mostly proximal M2 segment-middle cerebral artery occlusions, EVT has not yet been established as standard-of-care for MeVO strokes, and owing to the fragility of these small intracranial arteries, safety of EVT for MeVO is questionable and randomized trials are ongoing.
In comparison with EVT, a purely chemical strategy for MeVO strokes would be far less human-resource demanding, cheaper and feasible almost everywhere. In a previous study, the investigators showed results in favor of a high rate of recanalization at 24h in patients with stroke due to proximal occlusion with a dual IVT strategy (additional IVT with TNK in patients with persistent occlusion 1h after alteplase IVT), and this with a low hemorrhagic risk. Distal arterial occlusions are at lower hemorrhagic risk than proximal occlusions because volume infarcts are smaller, and because they spare basal ganglia, a critical location for massive hemorrhagic transformation of AIS. Moreover, patients could be carefully pre-selected with the initial MRI evaluation, allowing exclusion of patients with severe microangiopathy or amyloid angiopathy.
From March 1, 2014, to November 31, 2018, the investigators proposed a dual-IVT strategy (DIS) to patients admitted to the CHSF-Stroke Unit for MeVO-associated AIS eligible for IVT but not suitable for EVT. They were given a repeat MRI 1-2h after alteplase, 0.9 mg/kg, maximum 90 mg (IVT-1). If no recanalization was obtained and in the absence of exclusion criteria (acute lesion visible on FLAIR sequence, new cerebral/subarachnoid hemorrhage; significant extracerebral bleeding), a second IVT with TNK, 0.25 mg/kg, maximum 25 mg) (IVT-2) was given. The whole procedure was done within 6h of symptom onset.
During the same period, Bordeaux University Hospital-Stroke Unit constituted a cohort of consecutive patients with MeVO-AIS treated with conventional single-IVT strategy (SIS) using alteplase.
DIS- and SIS-cohort data were collected prospectively and the comparison was retrospective.
The pre-specified primary efficacy endpoint was successful recanalization assessed on MRI at 24h. The pre-specified primary safety endpoint was severe bleeding: symptomatic intracranial hemorrhage or major systemic bleeding during the first 36 hours. Secondary endpoints were: early neurological improvement at 24h, early complete neurological recovery at 24h and excellent (modified Rankin scale (mRS) 0-1) and good (mRS 0-2) clinical outcomes at 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-IVT strategy (SIS) cohort | – | Drug: alteplaseThe SIS cohort included patients with MeVO strokes who received a single conventional alteplase IVT (IVT-1). |
| Dual-IVT strategy (DIS) cohort | – | Drug: Alteplase + possible complementary IVT with tenecteplaseThe DIS cohort included patients with alteplase-treated MeVO strokes for whom a repeat MRI (MRI-2) was planned 1-2h after alteplase IVT (IVT-1) to discuss a possible complementary IVT with tenecteplase (TNK-IVT-2). Patients could be in the following situations: already recanalized at 1-2h post-alteplase IVT-1, persistent occlusion treated with TNK-IVT-2 or persistent occlusion but additional IVT contraindicated according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a bicentric retrospective study: Sud-Francilien Hospital (SFH), Corbeil-Essonnes, France for the DIVA cohort and Bordeaux University Hospital (BUH) for the standard treatment with alteplase alone cohort, based on stroke registries prospectively gathered. From March 2014 to November 2018, consecutive patients in SFH and BUH with acute ischemic stroke (AIS) due to distal occlusion assessed on brain MRI who fulfilled the inclusion/exclusion criteria were included in this retrospective analysis.
Key inclusion criteria (46 listed)
- Age≥ 18 years
- Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on initial MRI associated with distal arterial occlusion as defined below:
- IVT by ALT within 4h30 after onset of symptoms,
- MRI performed 24h after IVT
- Age≥ 18 years
Key exclusion criteria (6 listed)
- Patients informed of the study who objected to the collection of their data.
- Patients with >5 microbleeds; diffuse or focal cortical siderosis; severe leukoaraiosis (Fazekas score 3/3); any coagulopathy type, including a baseline international normalized ratio (INR) >1.3, were excluded for the SIS and DIS cohort.
- (Patients will be included in the DIS cohort but will not receive a secondary IVT with TNK ) Brain exclusion criteria on MRI-2: Early recanalization, acute lesion visible on FLAIR sequence, new cerebral/subarachnoid hemorrhage of any type or size.
- Significant extracerebral bleeding, such as abundant gingivorrhagia, epistaxis, multiple/diffuse ecchymoses or macroscopic hematuria.
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 |
|---|---|---|
| alteplaseIntravenous thrombolysis with alteplase (0.9 mg/kg, maximum 90 mg) with 10% of the dose given as a bolus followed by an infusion lasting 60 minutes. | Drug | Single-IVT strategy (SIS) cohort |
| Alteplase + possible complementary IVT with tenecteplaseIntravenous thrombolysis with alteplase (0.9 mg/kg, maximum 90 mg, with 10% of the dose given as a bolus followed by an infusion lasting 60 minutes) and depending on the MRI-2 results, an additional IVT with tenecteplase (0.25mg/kg, maximum 25 mg, with 100% of the dose given as a bolus) could be given in case of persistent occlusion and with no contraindication according to the study protocol. | Drug | Dual-IVT strategy (DIS) cohort |
Primary outcome
Recanalization rate assed on the control MRI at 24h (MRI-3) based on the Arterial Occlusive Lesion (AOL) score
Time frame: at 24 hours
Recanalization rate at 24h was evaluated on MRI-3 using the AOL scale. This scale was adapted for very distal occlusions which are not always clearly visible on magnetic resonance angiography (MRA). In these cases, AOL scale-score was based on gradient echo-sequences (GE): If occlusion visible on MRI: * no recanalization: AOL- 0, 1, 2a * successful recanalization : AOL-2b or 3 If occlusion not visible on MRA but thrombus visible on GE: * no recanalization : AOL-0 (unchanged thrombus) or AOL-1/AOL-2a (slight down-stream migration ore size reduction of the thrombus) * successful recanalization : AOL-2b (residual distal thrombus), or AOL-3 (complete thrombus disappearance).
4 secondary outcomes
Symptomatic intracranial Hemorrhages (sICH)
Time frame: at 24 hours
NIHSS
Time frame: at 24 hours
modified Rankin Scale score (mRS)
Time frame: at 3 months
mRS 6
Time frame: at 3 months
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 7 Nov 2023.
- Derived from this study: PubMed 38829011Chausson N, Olindo S, Laborne FX, Aghasaryan M, Renou P, Soumah D, Debruxelles S, Altarcha T, Poli M, L'Hermitte Y, Sagnier S, Toudou-Daouda M, Aminou-Tassiou NR, Bentamra L, Benmoussa N, Alecu C, Imbernon C, Smadja L, Ouanounou G, Rouanet F, Sibon I, Smadja D. Second-dose intravenous thrombolysis with tenecteplase in alteplase-resistant medium-vessel-occlusion strokes: A retrospective and comparative study. Eur Stroke J. 2024 Dec;9(4):943-951. doi: 10.1177/23969873241254936. Epub 2024 Jun 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Ischemic Stroke Due to Medium-vessel-occlusion, run by Centre Hospitalier Sud Francilien 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 46 inclusion and 6 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 7 Nov 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 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?
Recanalization rate assed on the control MRI at 24h (MRI-3) based on the Arterial Occlusive Lesion (AOL) score (time frame: at 24 hours). 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 NCT05809921, which also lists 1 linked publication.
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 7 Nov 2023.