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

Ischemic Stroke Clinical Trial

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

Status Terminated

Clinical 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT01874093
• Study type: Interventional
• Source: BrainsGate
• Status: Terminated
• Phase: Phase 3
• Start date: May 2013
• Completion date: June 2018