Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
ImpACT-24B
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
1 other identifier
interventional
1,078
18 countries
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2009
CompletedFirst Posted
Study publicly available on registry
January 21, 2009
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 24, 2020
March 1, 2019
7 years
January 19, 2009
February 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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.
90 days±7 days
Other Outcomes (9)
Subgroup analysis
90 days±7 days
Additional clinical efficacy outcome: SIS-16
90 days±7 days
Additional clinical efficacy outcome: Dichotomy 0-2 mRS at 3 months
90 days±7 days
- +6 more other outcomes
Study Arms (2)
Active Stimulation
ACTIVE COMPARATORImplantation/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 COMPARATORSham 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BrainsGatelead
Study Sites (73)
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27401, United States
University of Toledo Medical Center- Campus 1
Toledo, Ohio, 43606, United States
University of Toledo Medical Center- Campus 2
Toledo, Ohio, 43606, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
Erlanger Stroke Center
Chattanooga, Tennessee, 37403, United States
Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences
Calgary, Canada
Department of Medicine, Stroke Program, University of Alberta Hospital
Edmonton, Canada
University Hospital of Ostrava, Ostrava Poruba
Poruba, Czechia
General University Hospital
Prague, Czechia
Vitkovicka nemocnice a.s. Ostrava Vitkovice
Vítkovice, Czechia
Aarhus University Hospital
Aarhus, Denmark
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Hospital de la Cavale Blanche
Brest, France
Hospital Nord Laennec
Nantes, France
Hospital Saint Roch
Nice, France
Hopital Lariboisiere
Paris, France
Hospital Pontchaillou
Rennes, France
Unimed Adjara Batumi Referral Hospital
Batumi, Georgia
Kutaisi Referral Hospital
Kutaisi, Georgia
Rustavi Central Hospital
Rustavi, Georgia
Emergency Neurology Clinic Neurology Ltd.
Tbilisi, Georgia
First University Clinic
Tbilisi, Georgia
High Technology Medical Center University Clinic LTD.
Tbilisi, Georgia
Zugdidi Referral Hospital
Zugdidi, Georgia
Altenburg Clinic of Neurology
Altenburg, Germany
Bad Neustadt Neurological Clinic
Bad Neustadt an der Saale, Germany
Center for Stroke Research at Charite University of Berlin
Berlin, Germany
Erlangen University Clinic
Erlangen, Germany
Essen University Clinic
Essen, Germany
Heidelberg University Clinic
Heidelberg, Germany
Leipzig University Clinic
Leipzig, Germany
Technical University Munich
Munich, Germany
Schwarzwald-Baar Clinic
Villingen-Schwenningen, Germany
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Barzilai Medical Center
Ashkelon, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Sourasky Medical Center
Tel Aviv, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Israel
Hospital Sant'Andrea delle Fratte
Perugia, Italy
Policlinico Umberto I
Roma, Italy
University Clinic for Neurology
Skopje, North Macedonia
Bialystok University Hospital
Bialystok, Poland
Konske Hospital
Gmina Końskie, Poland
University Hospital in Krakow
Krakow, Poland
Sandomierz Hospital
Sandomierz, Poland
Torun Hospital
Torun, Poland
Institute of Psychiatry and Neurology
Warsaw, Poland
Hospital Fernando Fonseca
Amadora, Portugal
Hospital de Santo Antonio
Porto, Portugal
Unidade de AVC Centro Hospitalar São João
Porto, Portugal
Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria, Portugal
Special Hospital for Cerebrovascular Disease Sveti Sava
Belgrade, Serbia
Clinical Centre of Vojvodina
Novi Sad, Serbia
Clinical Hospital Center Zemun
Zemun, Serbia
Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská
Nová Ves, Slovakia
Neurologické Oddelenie FN Trnava, Fakultná Nemocnica
Trnava, Slovakia
Hospitalario Universitario de Albacete
Albacete, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Hospital Gregorio Maranon
Madrid, Spain
Ramon Y Cajal
Madrid, Spain
Hospital Universitario Son Dureta
Palma de Mallorca, Spain
Complejo Hospitalarion Univiersitario de Santiago
Santiago de Compostela, Spain
Valladolid - Hospital Clinico
Valladolid, Spain
Lviv National Medical University
Lviv, Ukraine
Related Publications (1)
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.
PMID: 31133406DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eyal Shay
BrainsGate
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2009
First Posted
January 21, 2009
Study Start
June 1, 2011
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
February 24, 2020
Record last verified: 2019-03