NCT00336596

Brief Summary

The purpose of the present, randomized, controlled multicenter phase III trial is to investigate the safety and efficacy of continuous 1-hour insonation of occluded middle cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue plasminogen activator (t-PA) within 3 hours after symptom onset.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach
1 country

6 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

June 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

June 13, 2006

Last Update Submit

April 25, 2007

Conditions

Intracranial EmbolismThrombosis

Keywords

middle cerebral artery occlusionintracranial embolism and thrombosisultrasound enhanced thrombolysisPatients receiving iv thrombolytic therapy (t-PA)

Outcome Measures

Primary Outcomes (2)

  • Symptomatic intracranial hemorrhage (safety)

  • Functional outcome (efficacy)

Secondary Outcomes (5)

  • Asymptomatic intracranial hemorrhage 24-48 hours after t-PA infusion

  • Early clinical recovery by 10 or more NIHSS points or dramatic recovery (total NIHSS 3 or less)at 24-48 hours after t-PA infusion

  • Mean mRS score at 90 days after t-PA infusion

  • Death occurring during study period

  • Recanalization at 24-48 hours after t-PA infusion

Interventions

transcranial ultrasound in patients treated with iv t-PAPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • acute ischemic stroke in the MCA territory according to clinical and cranial computed tomography (CT) or cranial MR imaging (MRI) findings
  • patient undergoing iv thrombolysis with t-PA within 3 hours after stroke onset
  • Occlusion of sphenoidal (M1) or insular (M2) segment of the MCA at CT (CTA), MR (MRA) or catheter (CA) angiography
  • appropriate temporal bony window without echocontrast agents for insonation with TCCS
  • full functional independence prior to present stroke (mRS 0-1), use of a cane for walking due to comorbid condition is acceptable
  • written informed consent, signed and dated by the subject (or subject's authorized representative, if allowed by local laws) and by the person obtaining the consent, indicating agreement to comply with all protocol-specific procedures

You may not qualify if:

  • unconsciousness (more than 2 points on item 1a on NIHSS)
  • history of intracranial hemorrhage, arteriovenous malformation or aneurysm
  • severe cranio-cerebral trauma within the last 3 months
  • symptoms of subarachnoidal hemorrhage
  • time of symptom onset unclear
  • large surgical intervention or trauma within the last 10 days
  • expected survival below 90 days after iv t-PA treatment
  • severe hepatic disease, esophageal varices, acute pancreatitis
  • septic embolism, endocarditis, pericarditis after myocardial infarction
  • pregnancy or childbirth within the last 30 days or nursing mothers
  • history of hemorrhagic diathesis or coagulopathy
  • untreatable increase of arterial blood pressure (\>185mmHg systolic, \>110mmHg diastolic)
  • intracranial hemorrhage, arteriovenous malformations or aneurysm at brain imaging
  • thrombocytes \<100'000 per microliter
  • international normalized ratio (INR)\>1.7 or partial thromboplastin time (PTT) prolongated
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kantonsspital Aarau, Department of Neurology

Aarau, Switzerland

RECRUITING

University Hospital of Basel, Department of Neurology

Basel, Switzerland

RECRUITING

University hospital of Bern, Department of Neurology

Bern, Switzerland

RECRUITING

University Hospital of Geneva, Department of Neurology

Geneva, Switzerland

RECRUITING

University Hospital of Lausanne, Department of Neurology

Lausanne, Switzerland

RECRUITING

University Hospital of Zurich, Department of Neurology

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Intracranial EmbolismThrombosisInfarction, Middle Cerebral ArteryIntracranial Embolism and Thrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and ThrombosisCerebral InfarctionBrain InfarctionBrain IschemiaCerebral Arterial DiseasesIntracranial Arterial DiseasesStrokeInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ralf W Baumgartner, MD

    University Hospital of Zurich, Department of Neurology, Zurich, Switzerland

    STUDY CHAIR

Central Study Contacts

Ralf W Baumgartner, MD

CONTACT

+41 1 255 56 86ralf.baumgartner@usz.ch

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 14, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2009

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

CH(6)