Ischemic StrokeTHRILLNCT02135926

Thrombectomy in Patients Ineligible for iv tPA

A study testing Thrombectomy and Best medical care in people with Ischemic Stroke, run by University Hospital Heidelberg at 19 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

the purpose of this study is to to compare the safety and effectiveness of stent-retrievers as a device class group with best medical care alone in the treatment of acute ischemic stroke (AIS) in patients who are not eligible for IV-tPA up to 8 hours of symptom onset. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ischemic Stroke
What is being tested?: Thrombectomy and Best medical care
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 19 sitesin 2 countries
Study dates: Mar 2014to 1 Feb 2017
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is ineligible for treatment with IV tPA according to licensing criteria (e.g.
anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).
Randomization within 7 hours after stroke onset.
Endovascular treatment is expected to be finished within 8 hours after symptom onset by judgment of the interventional Neuroradiologist in charge.
Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.
Female and male patient between 18-80 years of age

Show all 10Show fewer

NIHSS Score of >7 and <25
Patient signed informed consent (IC) form by patient, legal representative, or by an independent physician who is familiar with this types of illness if the other options are not possible.
A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA).
Prior to new focal neurological deficit, mRS score was ≤1.

Who cannot join

Patient is eligible for and receives IV tPA according to licensing criteria
Patient with an international normalized ratio (INR) of >3
Patient is an active participant in another drug or device treatment trial for any disease state, or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)

Show all 11Show fewer

Patient has history of contraindication for contrast medium.
Patient is known to have infective endocarditis
CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on unenhanced CT and cerebral blood volume (CBV) drop on CBV maps on Computed Tomography Perfusion (CTP), or, alternatively as per institutional standard, restricted diffusion on Diffusion weighted imaging (DWI) with an Alberta Stroke Program Early CT score (ASPECTs) of 6 or less
Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.
Patient"s anticipated life expectancy is less than 6 Months.

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

Germany18 sites

Klinik für Diagnostische und Interventionelle Neuroradiologie Universitätsklinikum Aachen
Aachen, 52074
Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln
Berlin, 12351
Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, 44892
University Clinic Bochum
Bochum
Diagnostik , Neuroradiologie, Universitätsklinikum Köln
Cologne, 50937
Kinik für Radiologie und Neuroradiologie
Dortmund, 44137
Abteilung für Neuroradiologie Universitätsklinikum Erlangen
Erlangen, 91054
Klinik für Radiologie und Neuroradiologie Alfried Krupp Krankenhaus
Essen, 45131
Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie Universitätsklinikum Essen
Essen, 45147
Klinik für Neuroradiologie Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Institut für Diagnostische & Interventionelle Neuroradiologie Universitätsmedizin Göttingen
Göttingen, 37075
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention
Hamburg, 20246
Asklepios Klinik Altona
Hamburg, 22763
Universität Heidelberg, Neuroradiologie
Heidelberg, 69120
Abteilung für Neuroradiologie Klinikum der Universität München Campus
München, 81377
Abteilung für Diagnostische & Interventionelle Neuroradiogie Klinikum rechts der Isar der TU München
München, 81675
Klinik für Radiologie, Neuroradiologie und Nuklearmedizin Behandlungszentrum Knappschaftskrankenhaus Recklinghausen
Recklinghausen, 45657
Abteilung für Neuroradiologie Universitätsklinikum Würzburg
Würzburg, 97080

Other trials in Germany

Austria1 site

Institut für Radiologie Oö. Gesundheits- und Spitals-AG Landes-Nervenklinik Wagner-Jauregg
Linz, 4020

Other trials in Austria

About this study

Official title: Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment

Read the detailed description

This is a prospective, binational (Germany and Austria), two-arm, randomized, controlled, open label, blinded endpoint post-market study to compare the safety and effectiveness of stent retrievers for thrombectomy compared to best medical treatment alone in acute ischemic stroke (AIS) patients not eligible for IV-tPA treatment.

Patients who meet the inclusion criteria will be randomized to one of the following two treatment arms:

best medical care alone or
best medical care plus endovascular thrombectomy with stent retriever (referred to as thrombectomy).

Endpoints in this prospective open label study will be assessed blinded to the treatment assignment of the patient (PROBE design). This study will be conducted in up to 20 centers in Germany and Austria. This is an adaptive design study, in which there are prospectively stated interim analyses with specified stopping rules, which allow for the possibility of the study to terminate early based on either a determination of study success or of the futility to continue further enrollment.

Up to six hundred (600) subjects, 300 per treatment group, will be enrolled and randomized in the study for the Intent to Treat (ITT) analysis set. The randomization will be stratified by time from symptom onset and stroke severity (NIHSS). The expected duration of each subject"s enrollment is approximately 90 days. Subjects will be followed with assessments at 30 (+/-6) hours, hospital discharge, and 90 (+/-14) days post stroke.

A blinded core laboratory will assess baseline imaging to confirm vessel occlusion and determine ASPECT score, 30 (+/- 6) hours post treatment imaging to assess presence of ICH, and to measure core infarct volume.

The primary effectiveness endpoint for a subject is the blinded evaluation of the ordinal mRS outcome at 90 days post-stroke. The primary effectiveness endpoint analysis is a chi-square test of the difference in linear trends in mRS outcomes at 90 days post-stroke between treatment groups ("mRS shift analysis").

Conditions: Ischemic Stroke
Being tested: Thrombectomy, Best medical care
Keywords: Cerebral Stroke, Stroke, Acute, Brain Infarction
Medical subject headings: Ischemic Stroke, Stroke, Brain Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ThrombectomyDevice
Also called Stent Retrievers, Solitaire (Covidien), Trevo (Stryker)
Stent retriever are intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease by providing temporary bypass across the occlusion and/or by the non-surgical removal of emboli and thrombi. They may be used with aspiration and with the injection or infusion of contrast media and/or other fluids. For subjects enrolled in this protocol who are randomly assigned to undergo the thrombectomy procedure, the device will be used according to the Instructions-for-Use (IFU) that is packaged with the device.
Best medical careOther
Also called clinical care, conservative treatment
Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.).

Study groups in NCT02135926
Study group	Role	What they receive
Best medical care	Active comparator	Best clinical care in dedicated stroke unit Receives: Other: Best medical care
Thrombectomy	Active comparator	All subjects randomly assigned to the thrombectomy arm, except those with rapidly improving neurologic symptoms or no angiographic evidence of occlusion, will be treated with the endorsed study devices (stent retriever). Receives: Device: Thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

mRS Shift
The primary endpoint of the trial is the modified Rankin Scale (mRS) outcome at 90 days poststroke. The primary effectiveness endpoint analysis is a chi-square test of the difference in linear trends in ordinal mRS outcomes at 90 days postprocedure between treatment groups ("mRS shift analysis"). The null and alternative hypotheses are β ≥ 0 and β < 0, respectively, where β is the treatment arm parameter in a proportional-odds logistic model with mRS category as response variable.
Measured: 90 (+/-14) days after treatment

Secondary outcomes (4)

Neurological outcome
Good neurological outcome with 90-day modified rankin Scale (mRS) ≤2 Good neurological outcome with 90-day NIHSS (National Institutes of Health Stroke Scale) improvement ≥10 from baseline Excellent neurological outcomes with 90-day mRS≤1
Measured: 90 (+/- 14) days after treatment
Health Status
Functional health status and quality of life 90 (±14) days after stroke (EQ-5D)
Measured: 90 (+/-14) days after treatment
Infarct volume
Infarct volume at 30 (-/+ 6) hours based on Computer Tomography or Magnetic Resonance Imaging compare to predicted infarct volume at time of patients hospital admission.
Measured: 30 (-/+ 6) hours after treatment
Successful Recanalization
For the endovascular treatment group successful recanalization will be defined as Thrombolysis in Cerebral Infarction scale (TICI) 2b or 3.
Measured: 30 (-/+ 6) hours after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 20141 Feb 2017

First posted12 May 2014 (estimated)
Study startMar 2014
Primary completion1 Feb 2017
Study completion1 Feb 2017

Why it stopped: Results from other RCT made randomization unethical.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for 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: Single blind
Who is masked: Participant
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02135926
Sponsor's protocol ID: UH-Heidelberg-THRILL
Other IDs: DRKS00005792
Acronym: THRILL
Status last verified: Jun 2018
First submitted: 30 Apr 2014
Last updated: 7 Jun 2018
Results posted: No
Data monitoring committee: Yes

Publications

Kelly ME, Furlan AJ, Fiorella D. Recanalization of an acute middle cerebral artery occlusion using a self-expanding, reconstrainable, intracranial microstent as a temporary endovascular bypass. Stroke. 2008 Jun;39(6):1770-3. doi: 10.1161/STROKEAHA.107.506212. Epub 2008 Apr 3.
PubMed 18388338
Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26.
PubMed 22932714
Penumbra Pivotal Stroke Trial Investigators. The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke. 2009 Aug;40(8):2761-8. doi: 10.1161/STROKEAHA.108.544957. Epub 2009 Jul 9.
PubMed 19590057
Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.
PubMed 22932715
Albers GW, Goldstein LB, Hess DC, Wechsler LR, Furie KL, Gorelick PB, Hurn P, Liebeskind DS, Nogueira RG, Saver JL; STAIR VII Consortium. Stroke Treatment Academic Industry Roundtable (STAIR) recommendations for maximizing the use of intravenous thrombolytics and expanding treatment options with intra-arterial and neuroprotective therapies. Stroke. 2011 Sep;42(9):2645-50. doi: 10.1161/STROKEAHA.111.618850. Epub 2011 Aug 18.
PubMed 21852620
Kastner B, Behre S, Lutz N, Burger F, Luntz S, Hinderhofer K, Bendszus M, Hoffmann GF, Ries M. Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses. PLoS One. 2015 Aug 14;10(8):e0135997. doi: 10.1371/journal.pone.0135997. eCollection 2015.
PubMed 26275228
Bendszus M, Thomalla G, Knauth M, Hacke W, Bonekamp S, Fiehler J. Thrombectomy in patients ineligible for iv tPA (THRILL). Int J Stroke. 2015 Aug;10(6):950-5. doi: 10.1111/ijs.12527. Epub 2015 Jun 4.
PubMed 26044962

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment
ClinicalTrials.gov ID: NCT02135926
Acronym / sponsor ID: THRILL / UH-Heidelberg-THRILL
Conditions: Ischemic Stroke
Keywords: Cerebral Stroke, Stroke, Acute, Brain Infarction
Study type: Interventional
Recruitment status: TerminatedReason stopped: Results from other RCT made randomization unethical.
Enrolment: 4 participants (actual)
Lead sponsor: University Hospital HeidelbergUniversity, hospital or other
Collaborators: University Hospital, Aachen, University Hospital Augsburg, Vivantes Krankenhaus Berlin Neukölln, Ruhr University of Bochum, Klinikum Dortmund Wirbelsäulenchirurgie, University of Erlangen-Nürnberg Medical School, Alfried Krupp Krankenhaus, University Hospital, Essen, University Hospital Freiburg, University Medical Center Goettingen, Universitätsklinikum Hamburg-Eppendorf, Universitätsklinik für Neurologie, Innsbruck, Universitätsklinikum Köln, The Wagner-Jauregg Provincial Neuropsychiatric Clinic, LMU Klinikum, Klinikum rechst der Isar Technische Universitaet Muenchen, KLINIKUM VEST Recklinghausen, Wuerzburg University Hospital, Asklepios Kliniken Hamburg GmbH
Study start: Mar 2014
Primary completion: 1 Feb 2017 (actual)
Study completion: 1 Feb 2017 (actual)
First posted: 12 May 2014 (estimated)
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.

Detailed description

Patients who meet the inclusion criteria will be randomized to one of the following two treatment arms:

best medical care alone or
best medical care plus endovascular thrombectomy with stent retriever (referred to as thrombectomy).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Best medical care	Active comparator	Other: Best medical careBest clinical care in dedicated stroke unit
Thrombectomy	Active comparator	Device: ThrombectomyAll subjects randomly assigned to the thrombectomy arm, except those with rapidly improving neurologic symptoms or no angiographic evidence of occlusion, will be treated with the endorsed study devices (stent retriever).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patient is ineligible for treatment with IV tPA according to licensing criteria (e.g.
anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).
Randomization within 7 hours after stroke onset.
Endovascular treatment is expected to be finished within 8 hours after symptom onset by judgment of the interventional Neuroradiologist in charge.
Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.

Key exclusion criteria (11 listed)

Patient is eligible for and receives IV tPA according to licensing criteria
Patient with an international normalized ratio (INR) of >3
Patient is an active participant in another drug or device treatment trial for any disease state, or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.

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
ThrombectomyAlso: Stent Retrievers, Solitaire (Covidien), Trevo (Stryker)Stent retriever are intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease by providing temporary bypass across the occlusion and/or by the non-surgical removal of emboli and thrombi. They may be used with aspiration and with the injection or infusion of contrast media and/or other fluids. For subjects enrolled in this protocol who are randomly assigned to undergo the thrombectomy procedure, the device will be used according to the Instructions-for-Use (IFU) that is packaged with the device.	Device	Thrombectomy
Best medical careAlso: clinical care, conservative treatmentBest medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.).	Other	Best medical care

Primary outcome

mRS Shift
Time frame: 90 (+/-14) days after treatment
The primary endpoint of the trial is the modified Rankin Scale (mRS) outcome at 90 days poststroke. The primary effectiveness endpoint analysis is a chi-square test of the difference in linear trends in ordinal mRS outcomes at 90 days postprocedure between treatment groups ("mRS shift analysis"). The null and alternative hypotheses are β ≥ 0 and β < 0, respectively, where β is the treatment arm parameter in a proportional-odds logistic model with mRS category as response variable.

4 secondary outcomes

Neurological outcome
Time frame: 90 (+/- 14) days after treatment
Health Status
Time frame: 90 (+/-14) days after treatment
Infarct volume
Time frame: 30 (-/+ 6) hours after treatment
Successful Recanalization
Time frame: 30 (-/+ 6) hours after treatment

Results and safety

The study was stopped early (reason given: Results from other RCT made randomization unethical.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
Background: PubMed 18388338Kelly ME, Furlan AJ, Fiorella D. Recanalization of an acute middle cerebral artery occlusion using a self-expanding, reconstrainable, intracranial microstent as a temporary endovascular bypass. Stroke. 2008 Jun;39(6):1770-3. doi: 10.1161/STROKEAHA.107.506212. Epub 2008 Apr 3.
Background: PubMed 22932714Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26.
Background: PubMed 19590057Penumbra Pivotal Stroke Trial Investigators. The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke. 2009 Aug;40(8):2761-8. doi: 10.1161/STROKEAHA.108.544957. Epub 2009 Jul 9.
Background: PubMed 22932715Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.
Background: PubMed 21852620Albers GW, Goldstein LB, Hess DC, Wechsler LR, Furie KL, Gorelick PB, Hurn P, Liebeskind DS, Nogueira RG, Saver JL; STAIR VII Consortium. Stroke Treatment Academic Industry Roundtable (STAIR) recommendations for maximizing the use of intravenous thrombolytics and expanding treatment options with intra-arterial and neuroprotective therapies. Stroke. 2011 Sep;42(9):2645-50. doi: 10.1161/STROKEAHA.111.618850. Epub 2011 Aug 18.
Derived from this study: PubMed 26275228Kastner B, Behre S, Lutz N, Burger F, Luntz S, Hinderhofer K, Bendszus M, Hoffmann GF, Ries M. Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses. PLoS One. 2015 Aug 14;10(8):e0135997. doi: 10.1371/journal.pone.0135997. eCollection 2015.
Derived from this study: PubMed 26044962Bendszus M, Thomalla G, Knauth M, Hacke W, Bonekamp S, Fiehler J. Thrombectomy in patients ineligible for iv tPA (THRILL). Int J Stroke. 2015 Aug;10(6):950-5. doi: 10.1111/ijs.12527. Epub 2015 Jun 4.

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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.

Martin Bendszus, MD principal investigator

University Hospital Heidelberg

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Thrombectomy and Best medical care in people with Ischemic Stroke, run by University Hospital Heidelberg at 19 sites in 2 countries.

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 10 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, Austria. 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: Results from other RCT made randomization unethical.). 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?

mRS Shift (time frame: 90 (+/-14) days after treatment). 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 NCT02135926, which also lists 7 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 7 Jun 2018.