Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01874093
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
Study:
NCT01874093
Study Brief:
Protocol Section:
NCT01874093