NCT03897153

Brief Summary

The purpose of this clinical investigation is to determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

March 28, 2019

Last Update Submit

March 28, 2019

Conditions

Stroke, Acute

Keywords

Stroke, Acute

Outcome Measures

Primary Outcomes (3)

  • Assessment of Brain Perfusion

    Measurement of the kinetic parameter time to peak (TTP) in the right and left-brain hemisphere during the SONAS® test

    24 hours

  • Comparison

    Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left-brain hemisphere

    7 days

  • Assessment of Adverse Events

    Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs

    72 hours

Study Arms (1)

Experimental:Diagnostic

EXPERIMENTAL

Diagnostic Test: SONAS® Ultrasound Device

Device: SONAS® Ultrasound Device

Interventions

SONAS® Ultrasound DeviceDEVICE

The SONAS® Ultrasound Device is intended for non-invasive transcranial ultrasound and used with a commercially approved contrast agent (e.g., Lumason®/SonoVue®).

Experimental:Diagnostic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent obtained
  • Male or female subject ≥18 years
  • Clinical diagnosis of acute stroke (NIHSS score: ≥10)
  • Time of stroke symptoms onset: ≤24 hours
  • Confirmed occlusion of either the proximal middle cerebral artery (occlusion of the proximal, middle or distal M1-segment) or the distal internal carotid artery (including carotid-T occlusion) by cMRI or cCT (including perfusion weighted imaging sequences)
  • Women of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin result, obtained within 24 hours before administration of SonoVue®
  • Women of non-childbearing potential can be included in the clinical investigation, if confirmed by fulfilling at least 1 of the following criteria:
  • Postmenopausal (age-related amenorrhea for ≥12 consecutive months)
  • Documentation (based on medical records, medical examination, or medical history interview) of irreversible surgical sterilization by bilateral oophorectomy, bilateral salpingectomy, or hysterectomy

You may not qualify if:

  • Subjects with known contraindications to the use of SonoVue®:
  • Subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and subjects with acute respiratory distress syndrome
  • SonoVue® must not be used in combination with dobutamine in subjects with conditions suggesting cardiovascular instability where dobutamine is contraindicated
  • Known hypersensitivity to any of the following substances:
  • Sulphur hexafluoride
  • Macrogol 4000
  • Distearoylphosphatidylcholine
  • Dipalmitoylphosphatidylglycerol sodium
  • Palmitic acid
  • Pregnant women
  • Subjects with severe cardiac or pulmonary disease as defined by the treating physician
  • Subjects with acute endocarditis and/or artificial heart valve
  • Subjects with acute systemic inflammation and/or sepsis
  • Subjects with hyperactive coagulation states and/or a recent thromboembolism
  • Subjects with end stage renal or hepatic disease
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinik für Neurologie / Medizinische Universität Wien

Vienna, 1090, Austria

NOT YET RECRUITING

Universitätsklinik für Neurologie / Universitätsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Andreas Cischek

CONTACT

+49 89 893 1190andreas.cischek@fgk-cro.com

Thilo Hoelscher, MD

CONTACT

619-277-3702thilo@burlconcepts.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 1, 2019

Study Start

February 12, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)DE(1)