NCT01399762

Brief Summary

The purpose of the Endostroke Registry is to gather information on predictors of good or poor clinical outcome following mechanical recanalization therapies for acute ischemic stroke.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

13 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

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

First QC Date

July 18, 2011

Last Update Submit

July 21, 2011

Conditions

Keywords

stroke, acutemechanical recanalizationinterventional neuroradiologyclinical registry

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome

    Proportion of patients with favourable clinical outcome defined as a Modified Rankin Score (MRS) of 0,1, or 2 three months after the intervention.

    approx. 90 days after stroke onset

Secondary Outcomes (2)

  • Angiographic outcome

    Day of intervention

  • Complication rate

    within 36 h after endovascular procedure

Study Arms (1)

mechanical recanalization

Patients with acute stroke being treated with endovascular devices for mechanical recanalization (no restriction to specific endovascular devices)

Device: mechanical recanalization

Interventions

Endovascular thrombus extraction by mechanical recanalization devices

mechanical recanalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke being treated with mechanical recanalization devices for proximal vessel occlusion of brain supplying arteries (i.e. MCA main stem occlusion, basilar artery occlusion, distal ICA occlusion)

You may qualify if:

  • Patients being treated with mechanical recanalization devices due to an acute proximal arterial vessel occlusion of brain supplying arteries

You may not qualify if:

  • Patients being treated with mechanical recanalization devices for venous vessel occlusion.
  • Patients being treated with mechanical recanalization devices due to an acute vessel occlusion which occured as a complication of an angiographic procedure scheduled for other reasons (i.e. as a complication of a diagnostic angiography or coiling procedure for cerebral aneurysms)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Departments of Neurology and Neuroradiology, University Hospital

Graz, 8036, Austria

RECRUITING

Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg

Linz, 4020, Austria

RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Aachen, 52074, Germany

ACTIVE NOT RECRUITING

Departments of Neurology and Radiology, Klinikum Altenburger Land

Altenburg, 04600, Germany

NOT YET RECRUITING

Departments of Neurology and Neuroradiology, Charite University Hospital

Berlin, 10117, Germany

RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Düsseldorf, 40255, Germany

ACTIVE NOT RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Essen, 45122, Germany

RECRUITING

Hirngefaesszentrum Goethe University

Frankfurt, 60528, Germany

RECRUITING

Departments of Neurology and Neuroradiology, Klinikum Fulda

Fulda, 36043, Germany

RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Giessen, 35385, Germany

ACTIVE NOT RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Kiel, 24105, Germany

ACTIVE NOT RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Mainz, 55131, Germany

ACTIVE NOT RECRUITING

Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus

Recklinghausen, 45657, Germany

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Oliver C. Singer, MD

    Hirngefaesszentrum Goethe University Frankfurt Germany

    PRINCIPAL INVESTIGATOR
  • Joachim Berkefeld, MD

    Hirngefaesszentrum Goethe University Frankfurt Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 22, 2011

Study Start

January 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations