Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-19 @ 9:11 PM
Study NCT ID:
NCT01874093
Status:
TERMINATED
Last Update Posted:
2018-06-26
First Post:
2013-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMPACT- 24Bt Post Mech. Thrombectomy and/or rtPA TRIAL IMPlant Augmenting Cerebral Blood Flow 24 Hours From Stroke Onset
Sponsor:
BrainsGate
Organization:
Study Overview
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
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT-24Bt
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: