International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Goethe University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Goethe University
ClinicalTrials.gov Identifier:
NCT01399762
First received: July 18, 2011
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Acute Stroke
Device: mechanical recanalization

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Clinical outcome [ Time Frame: approx. 90 days after stroke onset ] [ Designated as safety issue: No ]
    Proportion of patients with favourable clinical outcome defined as a Modified Rankin Score (MRS) of 0,1, or 2 three months after the intervention.


Secondary Outcome Measures:
  • Angiographic outcome [ Time Frame: Day of intervention ] [ Designated as safety issue: No ]
    Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.

  • Complication rate [ Time Frame: within 36 h after endovascular procedure ] [ Designated as safety issue: Yes ]
    Periprocedural complication rate defined as a combination of symptomatic intracranial hemorrhage (ECASS classification PH I and PH II), subarachnoid hemorrhage and thrombembolic events.


Estimated Enrollment: 500
Study Start Date: January 2011
Groups/Cohorts Assigned Interventions
mechanical recanalization
Patients with acute stroke being treated with endovascular devices for mechanical recanalization (no restriction to specific endovascular devices)
Device: mechanical recanalization
Endovascular thrombus extraction by mechanical recanalization devices

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

Criteria

Inclusion Criteria:

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399762

Contacts
Contact: Oliver C Singer, MD +49 69 6301 5942 o.singer@em.uni-frankfurt.de
Contact: Joachim Berkefeld, MD +49 69 6301 5462 berkefeld@em.uni-frankfurt.de

Locations
Austria
Departments of Neurology and Neuroradiology, University Hospital Recruiting
Graz, Austria, 8036
Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg Recruiting
Linz, Austria, 4020
Germany
Departments of Neurology and Neuroradiology, University Hospital Active, not recruiting
Aachen, Germany, 52074
Departments of Neurology and Radiology, Klinikum Altenburger Land Not yet recruiting
Altenburg, Germany, 04600
Departments of Neurology and Neuroradiology, Charite University Hospital Recruiting
Berlin, Germany, 10117
Departments of Neurology and Neuroradiology, University Hospital Active, not recruiting
Duesseldorf, Germany, 40255
Departments of Neurology and Neuroradiology, University Hospital Recruiting
Essen, Germany, 45122
Hirngefaesszentrum Goethe University Recruiting
Frankfurt, Germany, 60528
Departments of Neurology and Neuroradiology, Klinikum Fulda Recruiting
Fulda, Germany, 36043
Departments of Neurology and Neuroradiology, University Hospital Active, not recruiting
Giessen, Germany, 35385
Departments of Neurology and Neuroradiology, University Hospital Active, not recruiting
Kiel, Germany, 24105
Departments of Neurology and Neuroradiology, University Hospital Active, not recruiting
Mainz, Germany, 55131
Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus Active, not recruiting
Recklinghausen, Germany, 45657
Sponsors and Collaborators
Goethe University
Investigators
Principal Investigator: Oliver C. Singer, MD Hirngefaesszentrum Goethe University Frankfurt Germany
Principal Investigator: Joachim Berkefeld, MD Hirngefaesszentrum Goethe University Frankfurt Germany
  More Information

Additional Information:
No publications provided

Responsible Party: PD Dr. med. Oliver C. Singer, Hirngefaesszentrum der Goethe Universitaet
ClinicalTrials.gov Identifier: NCT01399762     History of Changes
Other Study ID Numbers: Endostroke_01
Study First Received: July 18, 2011
Last Updated: July 21, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Goethe University:
stroke, acute
mechanical recanalization
interventional neuroradiology
clinical registry

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014