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

Recruiting

Phase 3 Results N/A

Trial Description

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

Conditions

Interventions

  • The Ischemic Stroke System Device
    Intervention Desc: SPG stimulation and standard of care
    ARM 1: Kind: Experimental
    Label: Active Stimulation
  • Sham control Device
    Intervention Desc: Sham stimulation and standard of care
    ARM 1: Kind: Experimental
    Label: Sham Stimulation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Distribution of patients across the ordinal modified Rankin scale (mRS) 90 days No
Secondary Distribution of patients with NIHSS best language score ≥ 2 at screening across the ordinal modified Rankin scale (mRS) 90 days No

Sponsors