Ischemic StrokePhase 3IMPACT-24BtNCT01874093
IMPACT- 24Bt Post Mech. Thrombectomy and/or rtPA TRIAL IMPlant Augmenting Cerebral Blood Flow 24 Hours From Stroke Onset
A Phase 3 study testing The Ischemic Stroke System in people with Ischemic Stroke, run by BrainsGate at 1 site in Spain.
Trial summary
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in the anterior circulation, who received Mechanical Thrombectomy and/or IV-rtPA and Standard of Care. 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?
- The Ischemic Stroke System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- May 2013to Jun 2018
- Phase
- Phase 3
- 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: ≥ 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 based on general physical examination and neurological examination.
- Imaging findings demonstrating signs of ischemia (or total arterial occlusion prior to the MT procedure) in the anterior circulation, consistent with the clinical diagnosis.
- Performance of MT within <8 hours from stroke onset and/or administration of IV-rtPA within ≤ 4.5 hours from stroke onset.
- NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
- Ability to initiate treatment within
- ≤ 24 hours from stroke onset.
- Signed informed consent from patient him/herself or legally authorized representative if applicable.
Who cannot join
- Neuro-imaging evidence of any intracranial hemorrhage (including suspect of Sub Arachnoid Hemorrhage) or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess)
- Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
- Acute stroke due to lacunar infarct as defined by a clinical syndrome (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke, dysarthria-clumsy hand syndrome), unless brain imaging demonstrates a relevant lesion > 1.5 cm in size.
- Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
- Clinical signs and symptoms or imaging evidence of bilateral stroke.
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- Treated with IA-rtPA for the current stroke.
- Complicated MT procedure (including procedures with more than 3 clot removal attempts (catheter passes), or MT procedure that lasted more than 2 hours)
- NIHSS level of consciousness score ≥ 2.
- Previous stroke in the last 6 months or previous stroke with existing sequelae or with mRS > 0 for any reason
- Pre-existing disability; Pre-existing Modified Rankin Score >1, even if not stroke-related.
- Patients with bleeding propensity and/or one of the following: INR≥ 1.8, prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec., platelets count < 75×109/L prior to the implantation/sham procedure.
- Known cerebral arteriovenous malformation, cerebral aneurysm.
- Seizure at onset.
- Blood glucose concentration < 60 mg/dL.
- Clinical suspicion of septic embolus.
- Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the patient is taking antihypertensive medications.
- 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, etc.).
- History of SPG ablation ipsilateral to the stroke side.
- Any condition in the oral cavity that prevents implantation of the INS, such as patient is intubated, orthodontics or non-hygienic condition.
- Life expectancy < 1 year from causes other than stroke.
- Participating in any other therapeutic investigational trial within the last 30 days.
- Known sensitivity to any medication to be used during study.
- Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include: cardiovascular, vascular, pulmonary, hepatic, renal or neurological (other than acute ischemic stroke), or neoplastic diseases, as determined by medical history, physical examination, laboratory tests, or ECG.
- Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Rand., Double Blind, Sham Control, Parallel Arm Post Mech. Thrombectomy and/or rtPA Trial to Assess Safety and Effectiveness of the Ischemic Stroke System, as an Adjunct to Stand. of Care in Subjects With Acute Isch. Stroke
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in the anterior circulation, who received Mechanical Thrombectomy and/or IV-rtPA and Standard of Care.
Read the detailed description
This will be a multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing DSMB review of accumulated safety data.
The study has three phases:
Phase I - Implantation Safety Assessment
- Number of patients: 20 (at least 10 implantations)
- Implanters: only certified implanters who already performed implantation of ISS in previous studies
- Continue to the next phase if there are no serious procedure complications related to IV-rtPA (as determined by the implanter). Otherwise, implement retirements and continue only after DSMB approval.
DSMB meetings: after 10 implantations
Phase II - Symptomatic Intracranial Hemorrhage Assessment (sICH):
- Number of patients: 50 (additional 30)
- Implanters: all certified implanters
- Verify no clinically meaningful difference between treated and control. A clinically meaningful difference is a difference of more than 3 sICH cases within the first 5 days of treatment, in the treated arm compared to the control arm.
In case of clinically meaningful difference, implement retirements.
- Continue to phase III after DSMB approval.
- DSMB meetings: after 30 and 50 patients
Phase III - Entire study population, DSMB meetings at 100 and 150 patients
- Conditions
- Ischemic Stroke
- Being tested
- The Ischemic Stroke System, Sham control
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Ischemic Stroke SystemDevice
SPG stimulation and standard of care
Sham controlDevice
Sham stimulation and standard of care
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | INS implantation, 5 Days of Ischemic Stroke System (ISS) Stimulation + Standard of Care Receives: Device: The Ischemic Stroke System |
| Sham Stimulation | Sham comparator | Sham implantation, 5 Days of Sham Stimulation + Standard of Care Receives: Device: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of patients across the ordinal modified Rankin scale (mRS)
The primary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7.
The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.
Measured: 90 days
Secondary outcomes (1)
Distribution of patients with NIHSS best language score ≥ 2 at screening across the ordinal modified Rankin scale (mRS)
The secondary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7 for patients with NIHSS best language score ≥ 2 at screening.
The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainsGate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Shai, Study director, BrainsGate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874093
- Sponsor's protocol ID
- CLP1050035
- Acronym
- IMPACT-24Bt
- Status last verified
- Apr 2017
- First submitted
- 5 Jun 2013
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Rand., Double Blind, Sham Control, Parallel Arm Post Mech. Thrombectomy and/or rtPA Trial to Assess Safety and Effectiveness of the Ischemic Stroke System, as an Adjunct to Stand. of Care in Subjects With Acute Isch. Stroke
- ClinicalTrials.gov ID
- NCT01874093
- Acronym / sponsor ID
- IMPACT-24Bt / CLP1050035
- Conditions
- Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- BrainsGateIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Jun 2013 (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 a 24 hour window, in patients with an acute ischemic stroke in the anterior circulation, who received Mechanical Thrombectomy and/or IV-rtPA and Standard of Care.
Detailed description
This will be a multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing DSMB review of accumulated safety data.
The study has three phases:
Phase I - Implantation Safety Assessment
- Number of patients: 20 (at least 10 implantations)
- Implanters: only certified implanters who already performed implantation of ISS in previous studies
- Continue to the next phase if there are no serious procedure complications related to IV-rtPA (as determined by the implanter). Otherwise, implement retirements and continue only after DSMB approval.
DSMB meetings: after 10 implantations
Phase II - Symptomatic Intracranial Hemorrhage Assessment (sICH):
- Number of patients: 50 (additional 30)
- Implanters: all certified implanters
- Verify no clinically meaningful difference between treated and control. A clinically meaningful difference is a difference of more than 3 sICH cases within the first 5 days of treatment, in the treated arm compared to the control arm.
In case of clinically meaningful difference, implement retirements.
- Continue to phase III after DSMB approval.
- DSMB meetings: after 30 and 50 patients
Phase III - Entire study population, DSMB meetings at 100 and 150 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: The Ischemic Stroke SystemINS implantation, 5 Days of Ischemic Stroke System (ISS) Stimulation + Standard of Care |
| Sham Stimulation | Sham comparator | Device: Sham controlSham implantation, 5 Days of Sham Stimulation + Standard of Care |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: ≥ 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 based on general physical examination and neurological examination.
- Imaging findings demonstrating signs of ischemia (or total arterial occlusion prior to the MT procedure) in the anterior circulation, consistent with the clinical diagnosis.
- Performance of MT within <8 hours from stroke onset and/or administration of IV-rtPA within ≤ 4.5 hours from stroke onset.
- NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
Key exclusion criteria (27 listed)
- Neuro-imaging evidence of any intracranial hemorrhage (including suspect of Sub Arachnoid Hemorrhage) or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess)
- Massive stroke, defined as acute parenchymal lesion with effacement of cerebral sulci in over 2/3 of the MCA territory.
- Acute stroke due to lacunar infarct as defined by a clinical syndrome (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke, dysarthria-clumsy hand syndrome), unless brain imaging demonstrates a relevant lesion > 1.5 cm in size.
- Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
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 |
|---|---|---|
| The Ischemic Stroke SystemSPG stimulation and standard of care | Device | Active Stimulation |
| Sham controlSham stimulation and standard of care | Device | Sham Stimulation |
Primary outcome
Distribution of patients across the ordinal modified Rankin scale (mRS)
Time frame: 90 days
The primary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7. The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.
1 secondary outcome
Distribution of patients with NIHSS best language score ≥ 2 at screening across the ordinal modified Rankin scale (mRS)
Time frame: 90 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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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.
Eyal Shai study director
BrainsGate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The Ischemic Stroke System in people with Ischemic Stroke, run by BrainsGate at 1 site in Spain.
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 8 inclusion and 27 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 26 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 1 site in Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
Distribution of patients across the ordinal modified Rankin scale (mRS) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2018.