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Status unknownNCT01399762ENDOSTROKEUpdated Jul 22, 2011

International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke

An observational study in Acute Stroke, sponsored by Goethe University. Status unknown at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-22.

Sponsored by Goethe University · Observational

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Mechanical recanalization procedures are increasingly used in large vessel stroke, i.e. in proximal middle cerebral artery (MCA) or basilar artery (BA) occlusion. This trend is due to the limited efficacy of the only approved acute stroke treatment, systemic thrombolysis, in large vessel occlusion but also due to new technical innovations triggering the development of numerous devices for thrombus extraction. Within large single-arm trials, some of these devices demonstrated their potential with respect to acceptable complication- and substantial recanalization rates. Nevertheless, clinical outcome of these stroke patients is frequently poor despite an elaborate, aggressive, but also complex and costly treatment regimen. The factors determining good or poor clinical outcome in mechanical recanalization remain to be determined. The goal of the ENDOSTROKE-registry is the systemic evaluation of technical and clinical features that might be important for the further development and evaluation of endovascular treatment strategies for acute stroke. Special emphasis is laid on the assessment of clinical outcome (90 day MRS). Concerning technical and periprocedural aspects, a focus is put on time issues i.e. intra-hospital time delays, duration of angiographic procedures until vessel patency is achieved.It is planned to enroll approximately 500 patients in this registry. In first line, prospective patients will be included in the register (start date January 2011) but retrospective inclusion of patients being treated within the three years before the start of the register is allowed as long a consecutive patient registration is guaranteed (to exclude selection bias). Data analysis will include univariate and multivariate approaches with respect to clinical outcome measures.

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Conditions studied

  • Acute Stroke

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Keywords

  • stroke, acute
  • mechanical recanalization
  • interventional neuroradiology
  • clinical registry
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 500 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Goethe University is the lead sponsor of 97 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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)

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Observational model
Cohort
Enrollment
500 participants (estimated)

Groups and cohorts

  • mechanical recanalization

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

    Device: mechanical recanalization

Interventions

  • Devicemechanical recanalization

    Endovascular thrombus extraction by mechanical recanalization devices

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What researchers measure

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.

    Time frame: approx. 90 days after stroke onset

Secondary outcomes

  1. Angiographic outcome

    Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.

    Time frame: Day of intervention

  2. Complication rate

    Periprocedural complication rate defined as a combination of symptomatic intracranial hemorrhage (ECASS classification PH I and PH II), subarachnoid hemorrhage and thrombembolic events.

    Time frame: within 36 h after endovascular procedure

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Study locations

6 of 13 sites recruiting
  • 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
    Duesseldorf, 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01399762
Lead sponsor
Goethe University
First posted
Jul 22, 2011
Start date
Jan 2011
Last update
Jul 22, 2011

Study contacts

Oliver C Singer, MD
Contact
o.singer@em.uni-frankfurt.de
+49 69 6301 5942
Joachim Berkefeld, MD
Contact
berkefeld@em.uni-frankfurt.de
+49 69 6301 5462
Oliver C. Singer, MD
principal investigator · Hirngefaesszentrum Goethe University Frankfurt Germany
Joachim Berkefeld, MD
principal investigator · Hirngefaesszentrum Goethe University Frankfurt Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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