Ischemic StrokeImpACT-24BNCT00826059
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
A study testing Active Sphenopalatine Ganglion (SPG) Stimulation in people with Ischemic Stroke, run by BrainsGate at 73 sites in 18 countries.
Trial summary
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Active Sphenopalatine Ganglion (SPG) Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,078 participants
- Where
- 73 sitesin 18 countries
- Study dates
- Jun 2011to Jun 2018
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Between 40 years and 80 years for male and 85 for female subjects
- Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
- Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- Ability to initiate treatment within 8- 24 hours from stroke onset
- Signed informed consent from patient him/herself or legally authorized representative if applicable
Who cannot join
- Intracranial hemorrhage or hemorrhagic transformation
- Massive stroke
- Acute ischemic stroke in the posterior circulation
- Minor stroke
- Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke
- Previous stroke in the last 6 months or pre-existing disability
Show all 16Show fewer
- Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
- Clinical signs and symptoms or imaging evidence of bilateral stroke.
- Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
- Known cerebral arteriovenous malformation, cerebral aneurysm.
- Clinical suspicion of septic embolus.
- Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
- Serious systemic infection.
- Women known to be pregnant or having a positive or indeterminate pregnancy test.
- Patients with other implanted neural stimulator/ electronic devices (pacemakers).
- Life expectancy < 1 year from causes other than stroke.
Trial locations and contacts
73 sites in 18 countries.
73 sites in 18 countries
Spain11 sites
Hospitalario Universitario de Albacete
Albacete
Hospital de la Santa Creu I Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Arnau de Vilanova
Lleida
Hospital Gregorio Maranon
Madrid
Ramon Y Cajal
Madrid
Hospital Universitario Son Dureta
Palma de Mallorca
Complejo Hospitalarion Univiersitario de Santiago
Santiago de Compostela
Valladolid - Hospital Clinico
Valladolid
Germany9 sites
Altenburg Clinic of Neurology
Altenburg
Bad Neustadt Neurological Clinic
Bad Neustadt an der Saale
Center for Stroke Research at Charite University of Berlin
Berlin
Erlangen University Clinic
Erlangen
Essen University Clinic
Essen
Heidelberg University Clinic
Heidelberg
Leipzig University Clinic
Leipzig
Technical University Munich
Munich
Schwarzwald-Baar Clinic
Villingen-Schwenningen
United States7 sites
Erlanger Stroke Center
Chattanooga, Tennessee, 37403
Palmetto Health Richland
Columbia, South Carolina, 29203
Guilford Neurologic Associates
Greensboro, North Carolina, 27401
Intercoastal Medical Group
Sarasota, Florida, 34239
University of Toledo Medical Center- Campus 1
Toledo, Ohio, 43606
University of Toledo Medical Center- Campus 2
Toledo, Ohio, 43606
Central DuPage Hospital
Winfield, Illinois, 60190
Georgia7 sites
Unimed Adjara Batumi Referral Hospital
Batumi
Kutaisi Referral Hospital
Kutaisi
Rustavi Central Hospital
Rustavi
Emergency Neurology Clinic Neurology Ltd.
Tbilisi
First University Clinic
Tbilisi
High Technology Medical Center University Clinic LTD.
Tbilisi
Zugdidi Referral Hospital
Zugdidi
Poland6 sites
Bialystok University Hospital
Bialystok
Konske Hospital
Gmina Końskie
University Hospital in Krakow
Krakow
Sandomierz Hospital
Sandomierz
Torun Hospital
Torun
Institute of Psychiatry and Neurology
Warsaw
France5 sites
Hospital de la Cavale Blanche
Brest
Hospital Nord Laennec
Nantes
Hospital Saint Roch
Nice
Hopital Lariboisiere
Paris
Hospital Pontchaillou
Rennes
Israel5 sites
Barzilai Medical Center
Ashkelon
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Sourasky Medical Center
Tel Aviv
The Chaim Sheba Medical Center
Tel HaShomer
Portugal4 sites
Hospital Fernando Fonseca
Amadora
Hospital de Santo Antonio
Porto
Unidade de AVC Centro Hospitalar São João
Porto
Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria
Czechia3 sites
University Hospital of Ostrava, Ostrava Poruba
Poruba
General University Hospital
Prague
Vitkovicka nemocnice a.s. Ostrava Vitkovice
Vítkovice
Serbia3 sites
Special Hospital for Cerebrovascular Disease Sveti Sava
Belgrade
Clinical Centre of Vojvodina
Novi Sad
Clinical Hospital Center Zemun
Zemun
Canada2 sites
Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences
Calgary
Department of Medicine, Stroke Program, University of Alberta Hospital
Edmonton
Finland2 sites
Helsinki University Hospital
Helsinki
Kuopio University Hospital
Kuopio
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Italy2 sites
Hospital Sant'Andrea delle Fratte
Perugia
Policlinico Umberto I
Roma
Slovakia2 sites
Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská
Nová Ves
Neurologické Oddelenie FN Trnava, Fakultná Nemocnica
Trnava
About this study
Official title: A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.
Read the detailed description
A multi-center, multinational, randomized, blinded, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing Data Safety and Monitoring Board (DSMB) review of accumulated safety data.
Screening:
Since the treatment should be initiated within 24 hours from stroke onset, the screening window is limited and all procedures should be performed within this window.Subjects with Acute Ischemic Stroke will be screened upon arrival to the hospital. Since the treatment should be initiated between 8 and 24 hours from stroke onset, the screening window is limited and all procedures should be performed as soon as possible. All screened patients will be identified by patient number and will sign the informed consent prior to any study procedure initiation.
Period 1: Day 1-5
Day 1- Eligible subjects will be randomized to:
- Group 1: Implantation and ISS Stimulation during five consecutive days \& Standard of Care
- Group 2: Sham Implantation and Sham Stimulation during five consecutive days \& Standard of Care Subjects will be transferred to the implantation procedure facility and the implantation/sham implantation will be performed by a trained physician.
After implantation, active/sham stimulation will be administered in daily 4-hour sessions, beginning immediately following the placement procedure and continuing for 5 consecutive days.
Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed and the patients will be evaluated for safety and effectiveness.
Subjects will continue with Standard of Care as needed and will be released from the hospital upon investigator's judgment.
Period 2: Day of Discharge - 89±7 days During this period both groups (ISS Stimulation and Sham Control) will be treated according to Standard of Care either at the hospital, rehabilitation center or at home.
Scheduled visits will be performed on day 30±7 and day 60 ±7, which will include safety and effectiveness assessments.
Final Visit Day 90±7 days: The final visit will be performed at the study site and will include safety and effectiveness evaluations.
Patients will be contacted by study personnel via telephone on Day 180±7 and on Day 360±7 in order to assess their quality of life status.
- Conditions
- Ischemic Stroke
- Being tested
- Active Sphenopalatine Ganglion (SPG) Stimulation, Sham Sphenopalatine Ganglion (SPG) Stimulation
- Keywords
- acute ischemic stroke, randomized clinical trial, effectiveness, safety
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Sphenopalatine Ganglion (SPG) StimulationDevice
Also called Standard of Care
SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.
Sham Sphenopalatine Ganglion (SPG) StimulationDevice
Also called Standard of Care
Sham SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Active comparator | Implantation/ISS Stimulation during 5 consecutive days \& Standard of Care (SoC).
Day 1: First stimulation initiated within 24 hours from stroke onset, following implantation completion. All subjects will be treated according to SoC for treatment of Acute Ischemic Stroke.
Day 2-4: ISS Stimulation treatment sessions repeated daily. Each treatment will be initiated within 18-26 hours from the preceding treatment.
Day 5: Following completion of the last ISS Stimulation treatment session, imaging performed for assessing Injectable Neuro Stimulator (INS) positioning and/or lesion. Implant removal procedure will then be performed. Subsequently, patients will be evaluated for safety and effectiveness.
Subjects will continue with SoC as needed and discharged from the hospital based on the judgment of the study investigator. Receives: Device: Active Sphenopalatine Ganglion (SPG) Stimulation |
| Sham Stimulation | Sham comparator | Sham Implantation and Sham Stimulation during 5 consecutive days \& Standard of Care (SoC).
Day 1: First Sham stimulation initiated within 24 hours from stroke onset, following Sham implantation procedure. All subjects will be treated according to SoC for treatment of Acute Ischemic Stroke.
Day 2-4: Sham Stimulation sessions repeated daily. Each Sham Stimulation will be initiated within 18-26 hours from the preceding treatment.
Day 5: Following completion of the last Sham Stimulation session, imaging performed for lesion assessment. Sham Implant removal will then be performed. Subsequently, patients will be evaluated for safety and effectiveness.
Subjects will continue with SoC as needed and discharged from the hospital based on the judgment of the study investigator. Receives: Device: Sham Sphenopalatine Ganglion (SPG) Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
The primary efficacy endpoint is improvement beyond expectations on the modified Rankin Scale at 3 months (sliding dichotomy), assessed in primary populations of:
- modified intention to treat (mITT)
- confirmed cortical involvement (CCI), defined as baseline NIHSS ≥ 10 and signs of cortical involvement in baseline imaging (at least one of the following ASPECT regions: M1-M6, Insular Cortex) Type I Error is controlled at an overall level of 0.05 (two-sided) using the Hochberg method.
Measured: 90 days±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJun 2011
- Primary completionJun 2018
- Study completionJun 2018
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 Ischemic StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainsGate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Shay, Study director, BrainsGate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826059
- Sponsor's protocol ID
- CLP1000500
- Acronym
- ImpACT-24B
- Status last verified
- Mar 2019
- First submitted
- 19 Jan 2009
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bornstein NM, Saver JL, Diener HC, Gorelick PB, Shuaib A, Solberg Y, Thackeray L, Savic M, Janelidze T, Zarqua N, Yarnitsky D, Molina CA; ImpACT-24B investigators. An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial. Lancet. 2019 Jul 20;394(10194):219-229. doi: 10.1016/S0140-6736(19)31192-4. Epub 2019 May 24.
PubMed 31133406
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00826059
- Acronym / sponsor ID
- ImpACT-24B / CLP1000500
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, randomized clinical trial, effectiveness, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,078 participants (actual)
- Lead sponsor
- BrainsGateIndustry (pharma, biotech, devices)
- Study start
- Jun 2011 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 21 Jan 2009 (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.
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.
Detailed description
A multi-center, multinational, randomized, blinded, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing Data Safety and Monitoring Board (DSMB) review of accumulated safety data.
Screening:
Since the treatment should be initiated within 24 hours from stroke onset, the screening window is limited and all procedures should be performed within this window.Subjects with Acute Ischemic Stroke will be screened upon arrival to the hospital. Since the treatment should be initiated between 8 and 24 hours from stroke onset, the screening window is limited and all procedures should be performed as soon as possible. All screened patients will be identified by patient number and will sign the informed consent prior to any study procedure initiation.
Period 1: Day 1-5
Day 1- Eligible subjects will be randomized to:
- Group 1: Implantation and ISS Stimulation during five consecutive days \& Standard of Care
- Group 2: Sham Implantation and Sham Stimulation during five consecutive days \& Standard of Care Subjects will be transferred to the implantation procedure facility and the implantation/sham implantation will be performed by a trained physician.
After implantation, active/sham stimulation will be administered in daily 4-hour sessions, beginning immediately following the placement procedure and continuing for 5 consecutive days.
Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed and the patients will be evaluated for safety and effectiveness.
Subjects will continue with Standard of Care as needed and will be released from the hospital upon investigator's judgment.
Period 2: Day of Discharge - 89±7 days During this period both groups (ISS Stimulation and Sham Control) will be treated according to Standard of Care either at the hospital, rehabilitation center or at home.
Scheduled visits will be performed on day 30±7 and day 60 ±7, which will include safety and effectiveness assessments.
Final Visit Day 90±7 days: The final visit will be performed at the study site and will include safety and effectiveness evaluations.
Patients will be contacted by study personnel via telephone on Day 180±7 and on Day 360±7 in order to assess their quality of life status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Active comparator | Device: Active Sphenopalatine Ganglion (SPG) StimulationImplantation/ISS Stimulation during 5 consecutive days \& Standard of Care (SoC). Day 1: First stimulation initiated within 24 hours from stroke onset, following implantation completion. All subjects will be treated according to SoC for treatment of Acute Ischemic Stroke. Day 2-4: ISS Stimulation treatment sessions repeated daily. Each treatment will be initiated within 18-26 hours from the preceding treatment. Day 5: Following completion of the last ISS Stimulation treatment session, imaging performed for assessing Injectable Neuro Stimulator (INS) positioning and/or lesion. Implant removal procedure will then be performed. Subsequently, patients will be evaluated for safety and effectiveness. Subjects will continue with SoC as needed and discharged from the hospital based on the judgment of the study investigator. |
| Sham Stimulation | Sham comparator | Device: Sham Sphenopalatine Ganglion (SPG) StimulationSham Implantation and Sham Stimulation during 5 consecutive days \& Standard of Care (SoC). Day 1: First Sham stimulation initiated within 24 hours from stroke onset, following Sham implantation procedure. All subjects will be treated according to SoC for treatment of Acute Ischemic Stroke. Day 2-4: Sham Stimulation sessions repeated daily. Each Sham Stimulation will be initiated within 18-26 hours from the preceding treatment. Day 5: Following completion of the last Sham Stimulation session, imaging performed for lesion assessment. Sham Implant removal will then be performed. Subsequently, patients will be evaluated for safety and effectiveness. Subjects will continue with SoC as needed and discharged from the hospital based on the judgment of the study investigator. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Between 40 years and 80 years for male and 85 for female subjects
- Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
- Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- Ability to initiate treatment within 8- 24 hours from stroke onset
Key exclusion criteria (16 listed)
- Intracranial hemorrhage or hemorrhagic transformation
- Massive stroke
- Acute ischemic stroke in the posterior circulation
- Minor stroke
- Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke
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 |
|---|---|---|
| Active Sphenopalatine Ganglion (SPG) StimulationAlso: Standard of CareSPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods. | Device | Active Stimulation |
| Sham Sphenopalatine Ganglion (SPG) StimulationAlso: Standard of CareSham SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods. | Device | Sham Stimulation |
Primary outcome
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
Time frame: 90 days±7 days
The primary efficacy endpoint is improvement beyond expectations on the modified Rankin Scale at 3 months (sliding dichotomy), assessed in primary populations of: 1. modified intention to treat (mITT) 2. confirmed cortical involvement (CCI), defined as baseline NIHSS ≥ 10 and signs of cortical involvement in baseline imaging (at least one of the following ASPECT regions: M1-M6, Insular Cortex) Type I Error is controlled at an overall level of 0.05 (two-sided) using the Hochberg method.
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 24 Feb 2020.
- Derived from this study: PubMed 31133406Bornstein NM, Saver JL, Diener HC, Gorelick PB, Shuaib A, Solberg Y, Thackeray L, Savic M, Janelidze T, Zarqua N, Yarnitsky D, Molina CA; ImpACT-24B investigators. An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial. Lancet. 2019 Jul 20;394(10194):219-229. doi: 10.1016/S0140-6736(19)31192-4. Epub 2019 May 24.
Related trials for 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
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
Eyal Shay study director
BrainsGate
73 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Sphenopalatine Ganglion (SPG) Stimulation in people with Ischemic Stroke, run by BrainsGate at 73 sites in 18 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 6 inclusion and 16 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Spain, Germany, United States, Georgia, Poland and 13 more countries. 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. Some participants in this study may receive a placebo. 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?
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months (time frame: 90 days±7 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 NCT00826059, 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 24 Feb 2020.