Acute Ischemic StrokeINDIVIDUATENCT04578288
Individualized Blood Pressure Management During Endovascular Stroke Treatment
A study testing INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION in people with Acute Ischemic Stroke, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 21 Oct 2022
- 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
- Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
- Age 18 years or older, either sex
- National Institutes of Health Stroke Scale (NIHSS) ≥ 8
- Acute ischemic stroke in the anterior circulation with isolated or combined occlusion of: Internal carotid artery (ICA) and/or middle cerebral artery (MCA)
- Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment
Who cannot join
- Intracerebral hemorrhage
- Coma on admission (Glasgow Coma Scale ≤ 8)
- Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
- Intubated state before randomization
- Severe hemodynamic instability (e.g. due to decompensated heart insufficiency)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Individualized Blood Pressure Management During Endovascular Treatment of Acute Ischemic Stroke Under Procedural Sedation
Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. Low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. Retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. Some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. Intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. We aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. For this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (PROBE).
- Conditions
- Acute Ischemic Stroke
- Being tested
- INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATIONProcedure or surgery
The individual target range is defined as: bSBP ± 10 mmHg. The lowest possible SBP target range is 100-120 mmHg. The highest SBP target range is determined on the basis of whether patients receive concurrent IV fibrinolytic therapy or not. In patients where IV fibrinolytic therapy is applied, the highest SBP range is 160-180 mmHg, in patients without concurrent fibrinolytic therapy the highest SBP range is 180-200 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Standard Blood Pressure management | Active comparator | The standard blood pressure management is maintenance of intraprocedural pre-recanalization SBP between 140-180 mmHg for all patients who receive endovascular thrombectomy for acute ischemic stroke in anterior circulation. Receives: Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION |
| Individualized Blood Pressure management | Experimental | The study intervention would be maintaining the intraprocedural pre-recanalization blood pressure in individualized SBP target ranges depending on the systolic blood pressure of the patient at presentation (=baseline SBP or bSBP). Receives: Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome 90 days after stroke onset
modified Rankin scale (mRS) after 90 days dichotomized 0-2 by (favorable outcome) to 3-6 (unfavorable outcome).
Measured: 90 days
Secondary outcomes (4)
Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission
[NIHSS on admission - NIHSS after 24 hours]
Measured: 24 hours
Infarction size, determined with MRI or (in case of contraindications CT scan) 12-36 h after admission on a post-interventional follow up scan [milliliter]
Infarction size 12-36 hours after symptom onset
Measured: 12-36 hours
Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion]
Duration of thrombectomy procedure
Measured: Duration of thrombectomy procedure up to 240 minutes
Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion]
Duration of thrombectomy procedure
Measured: Duration of thrombectomy procedure up to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Silvia Schönenberger, MD, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578288
- Sponsor's protocol ID
- Heidelberg University Hospital
- Acronym
- INDIVIDUATE
- Status last verified
- Nov 2022
- First submitted
- 9 Sep 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rasmussen M, Schonenberger S, Henden PL, Valentin JB, Espelund US, Sorensen LH, Juul N, Uhlmann L, Johnsen SP, Rentzos A, Bosel J, Simonsen CZ; SAGA collaborators. Blood Pressure Thresholds and Neurologic Outcomes After Endovascular Therapy for Acute Ischemic Stroke: An Analysis of Individual Patient Data From 3 Randomized Clinical Trials. JAMA Neurol. 2020 May 1;77(5):622-631. doi: 10.1001/jamaneurol.2019.4838.
PubMed 31985746Lowhagen Henden P, Rentzos A, Karlsson JE, Rosengren L, Sundeman H, Reinsfelt B, Ricksten SE. Hypotension During Endovascular Treatment of Ischemic Stroke Is a Risk Factor for Poor Neurological Outcome. Stroke. 2015 Sep;46(9):2678-80. doi: 10.1161/STROKEAHA.115.009808. Epub 2015 Jul 14.
PubMed 26173727Schonenberger S, Uhlmann L, Ungerer M, Pfaff J, Nagel S, Klose C, Bendszus M, Wick W, Ringleb PA, Kieser M, Mohlenbruch MA, Bosel J. Association of Blood Pressure With Short- and Long-Term Functional Outcome After Stroke Thrombectomy: Post Hoc Analysis of the SIESTA Trial. Stroke. 2018 Jun;49(6):1451-1456. doi: 10.1161/STROKEAHA.117.019709. Epub 2018 May 2.
PubMed 29720440Whalin MK, Halenda KM, Haussen DC, Rebello LC, Frankel MR, Gershon RY, Nogueira RG. Even Small Decreases in Blood Pressure during Conscious Sedation Affect Clinical Outcome after Stroke Thrombectomy: An Analysis of Hemodynamic Thresholds. AJNR Am J Neuroradiol. 2017 Feb;38(2):294-298. doi: 10.3174/ajnr.A4992. Epub 2016 Nov 3.
PubMed 27811133Petersen NH, Ortega-Gutierrez S, Wang A, Lopez GV, Strander S, Kodali S, Silverman A, Zheng-Lin B, Dandapat S, Sansing LH, Schindler JL, Falcone GJ, Gilmore EJ, Amin H, Cord B, Hebert RM, Matouk C, Sheth KN. Decreases in Blood Pressure During Thrombectomy Are Associated With Larger Infarct Volumes and Worse Functional Outcome. Stroke. 2019 Jul;50(7):1797-1804. doi: 10.1161/STROKEAHA.118.024286. Epub 2019 Jun 4.
PubMed 31159701Chen M, Batra D, Bieber N, Sauer LD, Potreck A, Mohlenbruch M, Ringleb P, Schonenberger S. Determinants of procedural sedation requirements during endovascular treatment for acute anterior circulation ischaemic stroke: a post-hoc analysis of the INDIVIDUATE trial. Eur Stroke J. 2026 Aug 5;11(8):aakag102. doi: 10.1093/esj/aakag102.
PubMed 42673143Chen M, Sauer LD, Potreck A, Kieser M, Bendszus M, Ringleb P, Mohlenbruch M, Schonenberger S. Association of hemodynamic variability during endovascular stroke treatment with functional outcome and parenchymal hemorrhage. Ther Adv Neurol Disord. 2025 Nov 24;18:17562864251391837. doi: 10.1177/17562864251391837. eCollection 2025.
PubMed 41306441Chen M, Meis J, Potreck A, Sauer LD, Kieser M, Bendszus M, Wick W, Ringleb PA, Mohlenbruch MA, Schonenberger S. Effect of Individualized Versus Standardized Blood Pressure Management During Endovascular Stroke Treatment on Clinical Outcome: A Randomized Clinical Trial. Stroke. 2023 Nov;54(11):2755-2765. doi: 10.1161/STROKEAHA.123.044062. Epub 2023 Sep 21.
PubMed 37732489Chen M, Kronsteiner D, Mohlenbruch MA, Kieser M, Bendszus M, Wick W, Nagel S, Ringleb PA, Schonenberger S. Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) - An explorative randomized controlled trial. Eur Stroke J. 2021 Sep;6(3):276-282. doi: 10.1177/23969873211000879. Epub 2021 Mar 4.
PubMed 34746424
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Blood Pressure Management During Endovascular Treatment of Acute Ischemic Stroke Under Procedural Sedation
- ClinicalTrials.gov ID
- NCT04578288
- Acronym / sponsor ID
- INDIVIDUATE / Heidelberg University Hospital
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 8 Oct 2020 (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.
Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. Low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. Retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. Some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. Intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. We aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. For this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (PROBE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Blood Pressure management | Active comparator | Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATIONThe standard blood pressure management is maintenance of intraprocedural pre-recanalization SBP between 140-180 mmHg for all patients who receive endovascular thrombectomy for acute ischemic stroke in anterior circulation. |
| Individualized Blood Pressure management | Experimental | Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATIONThe study intervention would be maintaining the intraprocedural pre-recanalization blood pressure in individualized SBP target ranges depending on the systolic blood pressure of the patient at presentation (=baseline SBP or bSBP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
- Age 18 years or older, either sex
- National Institutes of Health Stroke Scale (NIHSS) ≥ 8
- Acute ischemic stroke in the anterior circulation with isolated or combined occlusion of: Internal carotid artery (ICA) and/or middle cerebral artery (MCA)
- Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment
Key exclusion criteria (5 listed)
- Intracerebral hemorrhage
- Coma on admission (Glasgow Coma Scale ≤ 8)
- Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
- Intubated state before randomization
- Severe hemodynamic instability (e.g. due to decompensated heart insufficiency)
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 |
|---|---|---|
| INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATIONThe individual target range is defined as: bSBP ± 10 mmHg. The lowest possible SBP target range is 100-120 mmHg. The highest SBP target range is determined on the basis of whether patients receive concurrent IV fibrinolytic therapy or not. In patients where IV fibrinolytic therapy is applied, the highest SBP range is 160-180 mmHg, in patients without concurrent fibrinolytic therapy the highest SBP range is 180-200 mmHg. | Procedure or surgery | Individualized Blood Pressure management, Standard Blood Pressure management |
Primary outcome
Functional outcome 90 days after stroke onset
Time frame: 90 days
modified Rankin scale (mRS) after 90 days dichotomized 0-2 by (favorable outcome) to 3-6 (unfavorable outcome).
4 secondary outcomes
Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission
Time frame: 24 hours
Infarction size, determined with MRI or (in case of contraindications CT scan) 12-36 h after admission on a post-interventional follow up scan [milliliter]
Time frame: 12-36 hours
Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion]
Time frame: Duration of thrombectomy procedure up to 240 minutes
Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion]
Time frame: Duration of thrombectomy procedure up to 240 minutes
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 8 Nov 2022.
- Background: PubMed 31985746Rasmussen M, Schonenberger S, Henden PL, Valentin JB, Espelund US, Sorensen LH, Juul N, Uhlmann L, Johnsen SP, Rentzos A, Bosel J, Simonsen CZ; SAGA collaborators. Blood Pressure Thresholds and Neurologic Outcomes After Endovascular Therapy for Acute Ischemic Stroke: An Analysis of Individual Patient Data From 3 Randomized Clinical Trials. JAMA Neurol. 2020 May 1;77(5):622-631. doi: 10.1001/jamaneurol.2019.4838.
- Background: PubMed 26173727Lowhagen Henden P, Rentzos A, Karlsson JE, Rosengren L, Sundeman H, Reinsfelt B, Ricksten SE. Hypotension During Endovascular Treatment of Ischemic Stroke Is a Risk Factor for Poor Neurological Outcome. Stroke. 2015 Sep;46(9):2678-80. doi: 10.1161/STROKEAHA.115.009808. Epub 2015 Jul 14.
- Background: PubMed 29720440Schonenberger S, Uhlmann L, Ungerer M, Pfaff J, Nagel S, Klose C, Bendszus M, Wick W, Ringleb PA, Kieser M, Mohlenbruch MA, Bosel J. Association of Blood Pressure With Short- and Long-Term Functional Outcome After Stroke Thrombectomy: Post Hoc Analysis of the SIESTA Trial. Stroke. 2018 Jun;49(6):1451-1456. doi: 10.1161/STROKEAHA.117.019709. Epub 2018 May 2.
- Background: PubMed 27811133Whalin MK, Halenda KM, Haussen DC, Rebello LC, Frankel MR, Gershon RY, Nogueira RG. Even Small Decreases in Blood Pressure during Conscious Sedation Affect Clinical Outcome after Stroke Thrombectomy: An Analysis of Hemodynamic Thresholds. AJNR Am J Neuroradiol. 2017 Feb;38(2):294-298. doi: 10.3174/ajnr.A4992. Epub 2016 Nov 3.
- Background: PubMed 31159701Petersen NH, Ortega-Gutierrez S, Wang A, Lopez GV, Strander S, Kodali S, Silverman A, Zheng-Lin B, Dandapat S, Sansing LH, Schindler JL, Falcone GJ, Gilmore EJ, Amin H, Cord B, Hebert RM, Matouk C, Sheth KN. Decreases in Blood Pressure During Thrombectomy Are Associated With Larger Infarct Volumes and Worse Functional Outcome. Stroke. 2019 Jul;50(7):1797-1804. doi: 10.1161/STROKEAHA.118.024286. Epub 2019 Jun 4.
- Derived from this study: PubMed 42673143Chen M, Batra D, Bieber N, Sauer LD, Potreck A, Mohlenbruch M, Ringleb P, Schonenberger S. Determinants of procedural sedation requirements during endovascular treatment for acute anterior circulation ischaemic stroke: a post-hoc analysis of the INDIVIDUATE trial. Eur Stroke J. 2026 Aug 5;11(8):aakag102. doi: 10.1093/esj/aakag102.
- Derived from this study: PubMed 41306441Chen M, Sauer LD, Potreck A, Kieser M, Bendszus M, Ringleb P, Mohlenbruch M, Schonenberger S. Association of hemodynamic variability during endovascular stroke treatment with functional outcome and parenchymal hemorrhage. Ther Adv Neurol Disord. 2025 Nov 24;18:17562864251391837. doi: 10.1177/17562864251391837. eCollection 2025.
- Derived from this study: PubMed 37732489Chen M, Meis J, Potreck A, Sauer LD, Kieser M, Bendszus M, Wick W, Ringleb PA, Mohlenbruch MA, Schonenberger S. Effect of Individualized Versus Standardized Blood Pressure Management During Endovascular Stroke Treatment on Clinical Outcome: A Randomized Clinical Trial. Stroke. 2023 Nov;54(11):2755-2765. doi: 10.1161/STROKEAHA.123.044062. Epub 2023 Sep 21.
- Derived from this study: PubMed 34746424Chen M, Kronsteiner D, Mohlenbruch MA, Kieser M, Bendszus M, Wick W, Nagel S, Ringleb PA, Schonenberger S. Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) - An explorative randomized controlled trial. Eur Stroke J. 2021 Sep;6(3):276-282. doi: 10.1177/23969873211000879. Epub 2021 Mar 4.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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?
A study testing INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION in people with Acute Ischemic Stroke, run by University Hospital Heidelberg at 1 site in Germany.
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 5 inclusion and 5 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 8 Nov 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 Germany. 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?
Functional outcome 90 days after stroke onset (time frame: 90 days). 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 NCT04578288, which also lists 9 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 8 Nov 2022.