Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window

NCT ID: NCT00826059

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1078 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2018-06-30

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Stimulation

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.

Group Type: ACTIVE_COMPARATOR

Active Sphenopalatine Ganglion (SPG) Stimulation

Intervention Type: DEVICE

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 Stimulation

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.

Group Type: SHAM_COMPARATOR

Sham Sphenopalatine Ganglion (SPG) Stimulation

Intervention Type: DEVICE

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.

Interventions

Active Sphenopalatine Ganglion (SPG) Stimulation

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

Sham Sphenopalatine Ganglion (SPG) Stimulation

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.

Intervention Type: DEVICE

Other Intervention Names

Standard of Care; Standard of Care

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrainsGate

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Shay

Role: STUDY_DIRECTOR

BrainsGate

Locations

Intercoastal Medical Group

Sarasota, Florida, United States

Central DuPage Hospital

Winfield, Illinois, United States

Guilford Neurologic Associates

Greensboro, North Carolina, United States

University of Toledo Medical Center- Campus 1

Toledo, Ohio, United States

University of Toledo Medical Center- Campus 2

Toledo, Ohio, United States

Palmetto Health Richland

Columbia, South Carolina, United States

Erlanger Stroke Center

Chattanooga, Tennessee, 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

Countries

United States; Canada; Czechia; Denmark; Finland; France; Georgia; Germany; Hong Kong; Israel; Italy; North Macedonia; Poland; Portugal; Serbia; Slovakia; Spain; Ukraine

References

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.

Reference Type: DERIVED

PMID: 31133406 (View on PubMed)

Other Identifiers

CLP1000500

Identifier Type: -

Identifier Source: org_study_id