IMPACT- 24Bt Post Mech. Thrombectomy and/or rtPA TRIAL IMPlant Augmenting Cerebral Blood Flow 24 Hours From Stroke Onset

NCT01874093 | Terminated Phase 3

• 1 other identifier: CLP1050035
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (1)

• Distribution of patients with NIHSS best language score ≥ 2 at screening across the ordinal modified Rankin scale (mRS)

  90 days

Study Arms (2)

Active Stimulation

EXPERIMENTAL

INS implantation, 5 Days of Ischemic Stroke System (ISS) Stimulation + Standard of Care

Device: The Ischemic Stroke System

Sham Stimulation

SHAM COMPARATOR

Sham implantation, 5 Days of Sham Stimulation + Standard of Care

Device: Sham control

Interventions

The Ischemic Stroke System DEVICE

SPG stimulation and standard of care

Active Stimulation

Sham control DEVICE

Sham stimulation and standard of care

Sham Stimulation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BrainsGate: lead

Study Sites (1)

Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eyal Shai

  BrainsGate

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 10, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2017-04

Locations

ES (1)