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

NCT01874093 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-06-26

No results posted yet for this study

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

Interventions

DEVICE

The Ischemic Stroke System

SPG stimulation and standard of care

DEVICE

Sham control

Sham stimulation and standard of care

Sponsors & Collaborators

  • BrainsGate

    lead INDUSTRY

Principal Investigators

  • Eyal Shai · BrainsGate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874093 on ClinicalTrials.gov