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Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24B)

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Active Sphenopalatine Ganglion (SPG) Stimulation
Sham Sphenopalatine Ganglion (SPG) Stimulation
Sponsored by
BrainsGate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring acute ischemic stroke, randomized clinical trial, effectiveness, safety

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: Between 40 years and 80 years for male and 85 for female subjects
  2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
  3. Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
  4. Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
  5. Ability to initiate treatment within 8- 24 hours from stroke onset
  6. Signed informed consent from patient him/herself or legally authorized representative if applicable

Exclusion Criteria:

  1. Intracranial hemorrhage or hemorrhagic transformation
  2. Massive stroke
  3. Acute ischemic stroke in the posterior circulation
  4. Minor stroke
  5. Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke
  6. Previous stroke in the last 6 months or pre-existing disability
  7. Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
  8. Clinical signs and symptoms or imaging evidence of bilateral stroke.
  9. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
  10. Known cerebral arteriovenous malformation, cerebral aneurysm.
  11. Clinical suspicion of septic embolus.
  12. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
  13. Serious systemic infection.
  14. Women known to be pregnant or having a positive or indeterminate pregnancy test.
  15. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
  16. Life expectancy < 1 year from causes other than stroke.

Sites / Locations

  • Intercoastal Medical Group
  • Central DuPage Hospital
  • Guilford Neurologic Associates
  • University of Toledo Medical Center- Campus 1
  • University of Toledo Medical Center- Campus 2
  • Palmetto Health Richland
  • Erlanger Stroke Center
  • Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences
  • Department of Medicine, Stroke Program, University of Alberta Hospital
  • University Hospital of Ostrava, Ostrava Poruba
  • General University Hospital
  • Vitkovicka nemocnice a.s. Ostrava Vitkovice
  • Aarhus University Hospital
  • Helsinki University Hospital
  • Kuopio University Hospital
  • Hospital de la Cavale Blanche
  • Hospital Nord Laennec
  • Hospital Saint Roch
  • Hopital Lariboisiere
  • Hospital Pontchaillou
  • Unimed Adjara Batumi Referral Hospital
  • Kutaisi Referral Hospital
  • Rustavi Central Hospital
  • Emergency Neurology Clinic Neurology Ltd.
  • First University Clinic
  • High Technology Medical Center University Clinic LTD.
  • Zugdidi Referral Hospital
  • Altenburg Clinic of Neurology
  • Bad Neustadt Neurological Clinic
  • Center for Stroke Research at Charite University of Berlin
  • Erlangen University Clinic
  • Essen University Clinic
  • Heidelberg University Clinic
  • Leipzig University Clinic
  • Technical University Munich
  • Schwarzwald-Baar Clinic
  • Prince of Wales Hospital
  • Queen Mary Hospital
  • Barzilai Medical Center
  • Hadassah Medical Center
  • Rabin Medical Center
  • Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • Hospital Sant'Andrea delle Fratte
  • Policlinico Umberto I
  • University Clinic for Neurology
  • Bialystok University Hospital
  • Konske Hospital
  • University Hospital in Krakow
  • Sandomierz Hospital
  • Torun Hospital
  • Institute of Psychiatry and Neurology
  • Hospital Fernando Fonseca
  • Hospital de Santo Antonio
  • Unidade de AVC Centro Hospitalar São João
  • Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião
  • Special Hospital for Cerebrovascular Disease Sveti Sava
  • Clinical Centre of Vojvodina
  • Clinical Hospital Center Zemun
  • Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská
  • Neurologické Oddelenie FN Trnava, Fakultná Nemocnica
  • Hospitalario Universitario de Albacete
  • Hospital de la Santa Creu I Sant Pau
  • Hospital del Mar
  • Hospital Universitari de Bellvitge
  • Hospital Vall d'Hebron
  • Hospital Arnau de Vilanova
  • Hospital Gregorio Maranon
  • Ramon Y Cajal
  • Hospital Universitario Son Dureta
  • Complejo Hospitalarion Univiersitario de Santiago
  • Valladolid - Hospital Clinico
  • Lviv National Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Stimulation

Sham Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2009
Last Updated
February 17, 2020
Sponsor
BrainsGate
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1. Study Identification

Unique Protocol Identification Number
NCT00826059
Brief Title
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
Acronym
ImpACT-24B
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BrainsGate

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
acute ischemic stroke, randomized clinical trial, effectiveness, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1078 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Sphenopalatine Ganglion (SPG) Stimulation
Other Intervention Name(s)
Standard of Care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Sphenopalatine Ganglion (SPG) Stimulation
Other Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
Description
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.
Time Frame
90 days±7 days
Other Pre-specified Outcome Measures:
Title
Subgroup analysis
Description
Primary parameters subgroup analysis by: NIHSS strata, lesion size, time from stroke onset strata, gender, age strata, Diabetes (Y/N), Atrial Fibrillation AFIB (Y/N) and side
Time Frame
90 days±7 days
Title
Additional clinical efficacy outcome: SIS-16
Description
Stroke-related quality of life at 3 months according to the Stroke Impact Scale-16 (SIS-16)
Time Frame
90 days±7 days
Title
Additional clinical efficacy outcome: Dichotomy 0-2 mRS at 3 months
Description
Functional independence at 3 months (modified Rankin Scale 0-2)
Time Frame
90 days±7 days
Title
Additional clinical efficacy outcome: Dichotomy 0-3 mRS at 3 months
Description
Up to moderate disability but ambulatory at 3 months (modified Rankin Scale 0-3)
Time Frame
90 days±7 days
Title
Safety outcome: Serious Adverse Event (SAE)
Description
All Serious Adverse Events (SAEs)
Time Frame
90 days±7 days
Title
Safety outcome: Serious Adverse Event (SAE) - Implantation
Description
SAEs related to implant placement or removal
Time Frame
90 days±7 days
Title
Safety outcome: Serious Adverse Event (SAE) - Stimulation
Description
SAEs related to stimulation
Time Frame
90 days±7 days
Title
Safety outcome: Neurological Deterioration
Description
An increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset
Time Frame
10 days
Title
Safety outcome: Mortality
Description
Mortality
Time Frame
90 days±7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Shay
Organizational Affiliation
BrainsGate
Official's Role
Study Director
Facility Information:
Facility Name
Intercoastal Medical Group
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Guilford Neurologic Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
University of Toledo Medical Center- Campus 1
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Toledo Medical Center- Campus 2
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Palmetto Health Richland
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Erlanger Stroke Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences
City
Calgary
Country
Canada
Facility Name
Department of Medicine, Stroke Program, University of Alberta Hospital
City
Edmonton
Country
Canada
Facility Name
University Hospital of Ostrava, Ostrava Poruba
City
Poruba
Country
Czechia
Facility Name
General University Hospital
City
Prague
Country
Czechia
Facility Name
Vitkovicka nemocnice a.s. Ostrava Vitkovice
City
Vítkovice
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Hospital de la Cavale Blanche
City
Brest
Country
France
Facility Name
Hospital Nord Laennec
City
Nantes
Country
France
Facility Name
Hospital Saint Roch
City
Nice
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
Country
France
Facility Name
Hospital Pontchaillou
City
Rennes
Country
France
Facility Name
Unimed Adjara Batumi Referral Hospital
City
Batumi
Country
Georgia
Facility Name
Kutaisi Referral Hospital
City
Kutaisi
Country
Georgia
Facility Name
Rustavi Central Hospital
City
Rustavi
Country
Georgia
Facility Name
Emergency Neurology Clinic Neurology Ltd.
City
Tbilisi
Country
Georgia
Facility Name
First University Clinic
City
Tbilisi
Country
Georgia
Facility Name
High Technology Medical Center University Clinic LTD.
City
Tbilisi
Country
Georgia
Facility Name
Zugdidi Referral Hospital
City
Zugdidi
Country
Georgia
Facility Name
Altenburg Clinic of Neurology
City
Altenburg
Country
Germany
Facility Name
Bad Neustadt Neurological Clinic
City
Bad Neustadt An Der Saale
Country
Germany
Facility Name
Center for Stroke Research at Charite University of Berlin
City
Berlin
Country
Germany
Facility Name
Erlangen University Clinic
City
Erlangen
Country
Germany
Facility Name
Essen University Clinic
City
Essen
Country
Germany
Facility Name
Heidelberg University Clinic
City
Heidelberg
Country
Germany
Facility Name
Leipzig University Clinic
City
Leipzig
Country
Germany
Facility Name
Technical University Munich
City
Munich
Country
Germany
Facility Name
Schwarzwald-Baar Clinic
City
Villingen-Schwenningen
Country
Germany
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petah tikva
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel HaShomer
Country
Israel
Facility Name
Hospital Sant'Andrea delle Fratte
City
Perugia
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
Country
Italy
Facility Name
University Clinic for Neurology
City
Skopje
Country
North Macedonia
Facility Name
Bialystok University Hospital
City
Białystok
Country
Poland
Facility Name
Konske Hospital
City
Końskie
Country
Poland
Facility Name
University Hospital in Krakow
City
Kraków
Country
Poland
Facility Name
Sandomierz Hospital
City
Sandomierz
Country
Poland
Facility Name
Torun Hospital
City
Toruń
Country
Poland
Facility Name
Institute of Psychiatry and Neurology
City
Warsaw
Country
Poland
Facility Name
Hospital Fernando Fonseca
City
Amadora
Country
Portugal
Facility Name
Hospital de Santo Antonio
City
Porto
Country
Portugal
Facility Name
Unidade de AVC Centro Hospitalar São João
City
Porto
Country
Portugal
Facility Name
Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião
City
Santa Maria
Country
Portugal
Facility Name
Special Hospital for Cerebrovascular Disease Sveti Sava
City
Belgrade
Country
Serbia
Facility Name
Clinical Centre of Vojvodina
City
Novi Sad
Country
Serbia
Facility Name
Clinical Hospital Center Zemun
City
Zemun
Country
Serbia
Facility Name
Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská
City
Nová Ves
Country
Slovakia
Facility Name
Neurologické Oddelenie FN Trnava, Fakultná Nemocnica
City
Trnava
Country
Slovakia
Facility Name
Hospitalario Universitario de Albacete
City
Albacete
Country
Spain
Facility Name
Hospital de la Santa Creu I Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
Country
Spain
Facility Name
Hospital Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Ramon Y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Son Dureta
City
Palma De Mallorca
Country
Spain
Facility Name
Complejo Hospitalarion Univiersitario de Santiago
City
Santiago De Compostela
Country
Spain
Facility Name
Valladolid - Hospital Clinico
City
Valladolid
Country
Spain
Facility Name
Lviv National Medical University
City
Lviv
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
31133406
Citation
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.
Results Reference
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Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window

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