Acute Ischemic Stroke (AIS) Related to a Distal OcclusionDISCOUNTNCT05030142
Evaluation of Mechanical Thrombectomy in Acute Ischemic Stroke Related to a Distal Arterial Occlusion
A study testing Mechanical Thrombectomy and Best medical treatment alone in people with Acute Ischemic Stroke (AIS) Related to a Distal Occlusion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Mechanical thrombectomy (MT) has shown its effectiveness for the treatment of acute ischemic stroke (AIS) related to large vessel occlusion and rapidly became a cornerstone in the management of these patients. No strong evidence is available on the benefit of MT in AIS related to more distal occlusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
- What is being tested?
- Mechanical Thrombectomy and Best medical treatment alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2021to 14 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years
- Delay between symptoms onset and expected groin puncture ≤ 6 h
- Symptomatic occlusion as evaluated by a National Institute of Health Stroke Score (NIHSS) ≥ 5
- Distal occlusion evaluated on CT angiography (CTA) or magnetic resonance imaging (MRI) and defined as an occlusion in one of the following segments:
- Distal M2, above the mid-height of the insula
- M3 segment
Show all 9Show fewer
- Posterior cerebral artery (PCA): P1, P2, P3 segments
- Anterior cerebral artery (ACA): A1, A2, A3 segments
- Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will be signed by the patient (if needed by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)
Who cannot join
- Pregnancy or breastfeeding woman
- Contra-indication for femoral, radial or humeral arterial puncture
- Tandem occlusion (i.e.: concomitant cervical and intra-cranial arterial occlusion)
- Allergy to iodinated contrast media
- Known renal insufficiency (confirmed by previous result of creatinine clearance < 30 ml/min)
- Secondary distal occlusion (i.e., complicating a MT for a proximal occlusion, or any other endovascular intracranial procedure)
Show all 17Show fewer
- Aortic dissection
- Asymptomatic or minor stroke (i.e.: NIHSS < 5)
- Pretreatment mRS > 1 (pre-stroke)
- Anticipated limitations for anesthesia
- Participation in another trial (Jardé 1 and Jardé 2)
- Absence of affiliation to National French social security system
- Under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- A pre-existing hemorrhage in the brain tissue fed by the target vessel
- Known hypersensitivity to nickel/titanium
- Stenosis and/or with a stent proximal to the site of the thrombus which could preclude the retrieval of the stent retriever
- Angiographic evidence of carotid dissection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Frédéric CLARENCON
Paris, 75013
Anne RADENNE, 0142161699
About this study
Official title: Evaluation of Mechanical Thrombectomy in Acute Ischemic Stroke Related to a Distal Arterial Occlusion: a Randomized Controlled Trial
Mechanical thrombectomy (MT) has shown its effectiveness for the treatment of acute ischemic stroke (AIS) related to large vessel occlusion and rapidly became a cornerstone in the management of these patients. No strong evidence is available on the benefit of MT in AIS related to more distal occlusions. Some previous observational studies suggested a possible benefit but most of them were single-centre and retrospective studies providing a very low level of evidence. To date, no randomized controlled trial has been conducted in this indication, which represents 10% to 20% of all AIS involving intracranial vessel occlusions.
This research is a multicenter open randomized controlled trial with two parallel groups : best medical treatment alone VS mechanical trombectomy + best medical treatment.
Read the detailed description
The main objective of this trial is to assess the efficacy of mechanical thrombectomy in addition to the best medical treatment as compared to the best medical treatment alone in AIS related to a distal intracranial artery occlusion. The medical device used will be a stent retriever among : Trevor NXT ProVue Retriever ; Catchview mini ; pReset Lite ; Tigertriever13, and the medical treatment used will depend on the stroke's etiology and will consist of IV trhombolysis or tenecteplase or antiplatelet therapy or anticoagulant therapy ... The main inclusion criteria are : 1) patients aged ≥ 18 years ; 2) Delay between symptoms onset and expected groin puncture ≤ 6h ; 3) Symptomatic occlusion as evaluated by a National Institute of Health Stroke Score (NIHSS) ≥ 5 ; 4) Distal occlusion evaluated on CT angiography (CTA) or magnetic resonance imaging (MRI) and defined as an occlusion in one of the following segments : a-Distal M2, above the mid-height of the insula, b-M3 segment, c-Posterior cerebral artery (PCA) = P1, P2 or P3 segment, d-Anterior cerebral artery (ACA) : A1, A2 or A3 segment ; 5) Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will be signed by the patient (if needed by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code).
The secondary objectives and endpoints are to evaluate the : 1) Success of the procedure defined as recanalization of the occluded vessel, evaluated on the AOL (Arterial Occlusion Lesion) score within 48 hours ; 2) Excellent clinical outcome (defined as a modified Rankin scale [mRS]≤1) at 3 months ; 3) Safety with reporting of all adverse and serious adverse events with a particular attention to perforation rate, embolus migration in a new territory and symptomatic hemorrhagic complications ; 4) Death rate up to 3 months ; 5) Cost effectiveness and utility of the procedure. The study will also evaluate the rate of angiographic reperfusion in the intervention group on the final angiogram at the end of the MT (which is part of the intervention) using the modified thrombolysis in cerebral infarction (mTICI) (2B-3) and the eTICI.
- Being tested
- Mechanical Thrombectomy, Best medical treatment alone
- Keywords
- Acute Ischemic Stroke, Distal occlusions, Mechanical Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyProcedure or surgery
Also called Experimental group
Mechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care)
Best medical treatment aloneDrug
Also called Control group
Best medical treatment alone (usual care)
| Study group | Role | What they receive |
|---|---|---|
| Mechanical thrombectomy | Experimental | Mechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care) Receives: Procedure: Mechanical Thrombectomy |
| Active Comparator | Active comparator | Best medical treatment alone (usual care) Receives: Drug: Best medical treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good clinical outcome (defined as a modified Rankin Scale [mRS] ≤ 2)
mRS of 0-2 (evaluated by an independent assessor blinded to the intervention received by the patient)
Measured: At 3 months
Secondary outcomes (12)
Recanalization of the occluded vessel
Evaluation of AOL (Arterial Occlusion Lesion scale) ≥ 2 on vascular brain imaging (magnetic resonance MR) or computed tomography (CT) angiography in patients belonging to both arms
Measured: 48 hours after the mechanical thrombectomy
Angiographic reperfusion in the intervention group
Use of the mTICI score (successful reperfusion: mTICI 2b-3) and the eTICI (extended thrombolysis in cerebral infarction) score (successful reperfusion: eTICI ≥ 2b67) on the control digital subtraction angiography (DSA)
Measured: End of the mechanical thrombectomy procedure
Excellent Clinical outcome (defined as a modified Rankin Scale [mRS] ≤ 1)
mRS of 0-1 (evaluated by an independent assessor blinded to the intervention received by the patient)
Measured: At 3 months
Perforation rate
Defined as contrast material extravasation either on digital subtraction angiography [DSA] or control CT scan
Measured: End of mechanical thrombectomy procedure
Embolus migration in a new territory
evaluated on digital subtraction angiography [DSA]
Measured: End of mechanical thrombectomy procedure
Symptomatic intracranial hemorrhage
evaluated on CT-scan or MRI according to the ECASS II criteria
Measured: within 7 days
Subarachnoid hemorrhage
evaluated on CT-scan or MRI and define as the abnormal presence of blood within the subarachnoid space presence of blood within the subarachnoid space
Measured: within 48 hours
Safety : incidence of adverse events
Reporting of all adverse events
Measured: At 3 months
Safety : incidence of serious adverse events
Reporting of all serious adverse events
Measured: At 3 months
Death rate
Mortality
Measured: At 3 months
Utility of the procedure
Incremental cost utility ratio
Measured: At 3 months
Cost effectiveness
Cost per additional survivor (health-economics analysis)
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 posted1 Sep 2021
- Study start14 Nov 2021
- Primary completion14 Feb 2024 (estimated)
- Study completion14 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke (AIS) Related to a Distal OcclusionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- None (open label)
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Clarençon, Professor, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030142
- Sponsor's protocol ID
- APHP200028
- Other IDs
- 2021-A00516-35
- Acronym
- DISCOUNT
- Status last verified
- Apr 2023
- First submitted
- 31 Jul 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Publications
Clarencon F, Bala F, Baptiste A, Pasi M, Marnat G, Sibon I, Gory B, Richard S, Pop R, Wolff V, Fauche C, Lamy M, Costalat V, Arquizan C, Rodriguez-Regent C, Turc G, Cognard C, Fontaine L, Di Maria F, Lapergue B, Bricout N, Henon H, Tuilier T, Wittwer A, Alexandre PL, De Gaalon S, Spelle L, Denier C, Chabert E, Ferrier A, Rouchaud A, Macian-Montoro F, Soize S, Moulin S, Boisseau W, Sabben C, Barbier C, Boulanger M, Eker OF, Cho TH, Gentric JC, Timsit S, Labeyrie MA, Reiner P, Pico F, Durand-Zaleski I, Alamowitch S, Dechartres A; DISCOUNT Investigators. Mechanical Thrombectomy in Ischemic Stroke With a Medium or Distal Arterial Occlusion: The DISCOUNT Randomized Clinical Trial. JAMA. 2026 Jul 22:e268977. doi: 10.1001/jama.2026.8977. Online ahead of print.
PubMed 42485024Clarencon F, Durand-Zaleski I, Premat K, Baptiste A, Chabert E, Ferrier A, Labeyrie MA, Reiner P, Spelle L, Denier C, Tuilier T, Hosseini H, Rodriguez-Regent C, Turc G, Fauche C, Lamy M, Lapergue B, Consoli A, Barbier C, Boulanger M, Bricout N, Henon H, Gory B, Richard S, Rouchaud A, Macian-Montoro F, Eker O, Cho TH, Soize S, Moulin S, Gentric JC, Timsit S, Darcourt J, Albucher JF, Janot K, Annan M, Pico F, Costalat V, Arquizan C, Marnat G, Sibon I, Pop R, Wolff V, Shotar E, Lenck S, Sourour NA, Radenne A, Alamowitch S, Dechartres A. Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial. Int J Stroke. 2024 Mar;19(3):367-372. doi: 10.1177/17474930231205213. Epub 2023 Oct 12.
PubMed 37740419
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mechanical Thrombectomy in Acute Ischemic Stroke Related to a Distal Arterial Occlusion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05030142
- Acronym / sponsor ID
- DISCOUNT / APHP200028
- Keywords
- Acute Ischemic Stroke, Distal occlusions, Mechanical Thrombectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 14 Feb 2024 (estimated)
- First posted
- 1 Sep 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.
Mechanical thrombectomy (MT) has shown its effectiveness for the treatment of acute ischemic stroke (AIS) related to large vessel occlusion and rapidly became a cornerstone in the management of these patients. No strong evidence is available on the benefit of MT in AIS related to more distal occlusions. Some previous observational studies suggested a possible benefit but most of them were single-centre and retrospective studies providing a very low level of evidence. To date, no randomized controlled trial has been conducted in this indication, which represents 10% to 20% of all AIS involving intracranial vessel occlusions.
This research is a multicenter open randomized controlled trial with two parallel groups : best medical treatment alone VS mechanical trombectomy + best medical treatment.
Detailed description
The main objective of this trial is to assess the efficacy of mechanical thrombectomy in addition to the best medical treatment as compared to the best medical treatment alone in AIS related to a distal intracranial artery occlusion. The medical device used will be a stent retriever among : Trevor NXT ProVue Retriever ; Catchview mini ; pReset Lite ; Tigertriever13, and the medical treatment used will depend on the stroke's etiology and will consist of IV trhombolysis or tenecteplase or antiplatelet therapy or anticoagulant therapy ... The main inclusion criteria are : 1) patients aged ≥ 18 years ; 2) Delay between symptoms onset and expected groin puncture ≤ 6h ; 3) Symptomatic occlusion as evaluated by a National Institute of Health Stroke Score (NIHSS) ≥ 5 ; 4) Distal occlusion evaluated on CT angiography (CTA) or magnetic resonance imaging (MRI) and defined as an occlusion in one of the following segments : a-Distal M2, above the mid-height of the insula, b-M3 segment, c-Posterior cerebral artery (PCA) = P1, P2 or P3 segment, d-Anterior cerebral artery (ACA) : A1, A2 or A3 segment ; 5) Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will be signed by the patient (if needed by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code).
The secondary objectives and endpoints are to evaluate the : 1) Success of the procedure defined as recanalization of the occluded vessel, evaluated on the AOL (Arterial Occlusion Lesion) score within 48 hours ; 2) Excellent clinical outcome (defined as a modified Rankin scale [mRS]≤1) at 3 months ; 3) Safety with reporting of all adverse and serious adverse events with a particular attention to perforation rate, embolus migration in a new territory and symptomatic hemorrhagic complications ; 4) Death rate up to 3 months ; 5) Cost effectiveness and utility of the procedure. The study will also evaluate the rate of angiographic reperfusion in the intervention group on the final angiogram at the end of the MT (which is part of the intervention) using the modified thrombolysis in cerebral infarction (mTICI) (2B-3) and the eTICI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical thrombectomy | Experimental | Procedure: Mechanical ThrombectomyMechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care) |
| Active Comparator | Active comparator | Drug: Best medical treatment aloneBest medical treatment alone (usual care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged ≥ 18 years
- Delay between symptoms onset and expected groin puncture ≤ 6 h
- Symptomatic occlusion as evaluated by a National Institute of Health Stroke Score (NIHSS) ≥ 5
- Distal occlusion evaluated on CT angiography (CTA) or magnetic resonance imaging (MRI) and defined as an occlusion in one of the following segments:
- Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will be signed by the patient (if needed by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)
Key exclusion criteria (17 listed)
- Pregnancy or breastfeeding woman
- Contra-indication for femoral, radial or humeral arterial puncture
- Tandem occlusion (i.e.: concomitant cervical and intra-cranial arterial occlusion)
- Allergy to iodinated contrast media
- Known renal insufficiency (confirmed by previous result of creatinine clearance < 30 ml/min)
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 |
|---|---|---|
| Mechanical ThrombectomyAlso: Experimental groupMechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care) | Procedure or surgery | Mechanical thrombectomy |
| Best medical treatment aloneAlso: Control groupBest medical treatment alone (usual care) | Drug | Active Comparator |
Primary outcome
Good clinical outcome (defined as a modified Rankin Scale [mRS] ≤ 2)
Time frame: At 3 months
mRS of 0-2 (evaluated by an independent assessor blinded to the intervention received by the patient)
12 secondary outcomes
Recanalization of the occluded vessel
Time frame: 48 hours after the mechanical thrombectomy
Angiographic reperfusion in the intervention group
Time frame: End of the mechanical thrombectomy procedure
Excellent Clinical outcome (defined as a modified Rankin Scale [mRS] ≤ 1)
Time frame: At 3 months
Perforation rate
Time frame: End of mechanical thrombectomy procedure
Embolus migration in a new territory
Time frame: End of mechanical thrombectomy procedure
Symptomatic intracranial hemorrhage
Time frame: within 7 days
Subarachnoid hemorrhage
Time frame: within 48 hours
Safety : incidence of adverse events
Time frame: At 3 months
Safety : incidence of serious adverse events
Time frame: At 3 months
Death rate
Time frame: At 3 months
Utility of the procedure
Time frame: At 3 months
Cost effectiveness
Time frame: At 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 42485024Clarencon F, Bala F, Baptiste A, Pasi M, Marnat G, Sibon I, Gory B, Richard S, Pop R, Wolff V, Fauche C, Lamy M, Costalat V, Arquizan C, Rodriguez-Regent C, Turc G, Cognard C, Fontaine L, Di Maria F, Lapergue B, Bricout N, Henon H, Tuilier T, Wittwer A, Alexandre PL, De Gaalon S, Spelle L, Denier C, Chabert E, Ferrier A, Rouchaud A, Macian-Montoro F, Soize S, Moulin S, Boisseau W, Sabben C, Barbier C, Boulanger M, Eker OF, Cho TH, Gentric JC, Timsit S, Labeyrie MA, Reiner P, Pico F, Durand-Zaleski I, Alamowitch S, Dechartres A; DISCOUNT Investigators. Mechanical Thrombectomy in Ischemic Stroke With a Medium or Distal Arterial Occlusion: The DISCOUNT Randomized Clinical Trial. JAMA. 2026 Jul 22:e268977. doi: 10.1001/jama.2026.8977. Online ahead of print.
- Derived from this study: PubMed 37740419Clarencon F, Durand-Zaleski I, Premat K, Baptiste A, Chabert E, Ferrier A, Labeyrie MA, Reiner P, Spelle L, Denier C, Tuilier T, Hosseini H, Rodriguez-Regent C, Turc G, Fauche C, Lamy M, Lapergue B, Consoli A, Barbier C, Boulanger M, Bricout N, Henon H, Gory B, Richard S, Rouchaud A, Macian-Montoro F, Eker O, Cho TH, Soize S, Moulin S, Gentric JC, Timsit S, Darcourt J, Albucher JF, Janot K, Annan M, Pico F, Costalat V, Arquizan C, Marnat G, Sibon I, Pop R, Wolff V, Shotar E, Lenck S, Sourour NA, Radenne A, Alamowitch S, Dechartres A. Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial. Int J Stroke. 2024 Mar;19(3):367-372. doi: 10.1177/17474930231205213. Epub 2023 Oct 12.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Frédéric Clarençon, Professor principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Thrombectomy and Best medical treatment alone in people with Acute Ischemic Stroke (AIS) Related to a Distal Occlusion, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 17 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 18 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Clarençon, Professor (+ 33 1 42 16 35 43, frederic.clarencon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good clinical outcome (defined as a modified Rankin Scale [mRS] ≤ 2) (time frame: At 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 NCT05030142, which also lists 2 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 18 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.