Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A) (ImpACT-24A)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study was first registered as NCT00826059 on January 19, 2009 under the name ImpACT-24.
Background:
Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed. Later, it was decided to define the first part (before the halt) as a separate study - ImpACT-24A, and identify the continuation of the study as ImpACT-24B. ImpACT-24B continues to be registered as NCT00826059, and ImpACT-24A is registered in this new record.
Detailed Description:
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study with ongoing DSMB review of accumulated safety data.
Screening:
Treatment should be initiated between 8 and 24 hours from stroke onset. 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 in a 2:1 (ISS Stimulation: Sham Control) ratio:
Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of Care Group 2: Implantation and Sham Stimulation during five consecutive days & Standard of Care The implantation will be performed by a trained physician. Stimulation/sham stimulation will be delivered Day 2-5 ISS / Sham Stimulation will be repeated during the following four consecutive days by trained personnel within 18-26 hours from preceding stimulation.
Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed.
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 - 90±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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- Erlanger Stroke Center
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-
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Barcelona, Spania
- Hospital Vall d'hebrón
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Girona, Spania
- Hospital Universitari de Girona
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Erlangen, Tyskland
- Erlangen University Clinic
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Essen, Tyskland
- Essen University Clinic
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Heidelberg, Tyskland
- Heidelberg University Clinic
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Leipzig, Tyskland
- Leipzig University Clinic
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Münster, Tyskland
- Munster University Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age: ≥ 18 years and ≤ 85 of both genders.
- Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- Baseline NIHSS ≥ 7 and ≤ 18
- Ability to initiate treatment within 8- 24 hours from stroke onset.
Exclusion Criteria:
- Intracranial hemorrhage or hemorrhagic transformation
- Massive stroke
- Acute ischemic stroke in the posterior circulation
- Minor stroke
- Treated with IV-tPA ,IA-tPA 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
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Active Stimulation
Device: The Ischemic Stroke System SPG stimulation and standard of care
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SPG stimulation and standard of care
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Sham-komparator: Sham Stimulation
Device: Sham control Sham stimulation and standard of care
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Sham SPG stimulation and standard of care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
Tidsramme: 90 ±7 days
|
Final global disability level on the modified Rankin scale (mRS) at 3 months better than expectation (sliding dichotomy analysis) ) assessed in the modified intention to treat (mITT) population defined as all randomized subjects receiving at least the minimal exposure of 1 treatment (ISS Stimulation or Sham Control) session out of the 5 planned sessions. mRS Scale:
|
90 ±7 days
|
|
Number of participants with Serious Adverse Events
Tidsramme: 90 ±7 days
|
Comparison between the active and sham stimulation groups of all serious adverse events (SAEs)
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90 ±7 days
|
|
Number of participants with neurological deterioration
Tidsramme: 10 days
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Comparison between the active and sham stimulation groups of the rate of neurological deterioration, defined as an increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset
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10 days
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Number of participants with implantation complications
Tidsramme: 90 ±7 days
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The rate of implantation complications as classified by the investigator
|
90 ±7 days
|
|
Number of participants with stimulation-related adverse events
Tidsramme: 90 ±7 days
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Comparison between the active and sham stimulation groups of stimulation-related adverse events as classified by the investigator
|
90 ±7 days
|
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Mortality rate
Tidsramme: 90 ±7 days
|
Comparison of mortality rates between the active and sham stimulation groups
|
90 ±7 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline
Tidsramme: 90 ±7 days
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Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline mRS Scale:
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90 ±7 days
|
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Binary NIHSS at Day 90
Tidsramme: 90 ±7 days
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Binary NIHSS (success for score ≤1 or for ≥ 9-point improvement versus baseline) The NIHSS (National Institute of Health Stroke Score) is a 42-point scale that quantifies neurological deficits in 11 categories. Ratings for each item are scored with 3 to 5 grades, with 0 as normal. |
90 ±7 days
|
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Stroke-related quality of life at 3 months: Stroke Impact Scale-16
Tidsramme: 90 ±7 days
|
Stroke-related quality of life at 3 months according to the Stroke Impact Scale-16 (SIS-16) The scale is based on a questionnaire with 16 items. Each answer ranges from 1 (poor) to 5 (good). A final single-item Recovery domain assesses the individual's perception of his/her recovery from stroke, where: 0 = no recovery 100 = full recovery. Domain scores range from 0-100 and are calculated using the following equation: Domain score = [(Mean item score - 1) / (5-1) ] x 100 |
90 ±7 days
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLP1000500-24A
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