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

Study Description

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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.

Condition or disease	Intervention/treatment
Acute Stroke	Device: mechanical recanalization

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Official Title:	International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)
Study Start Date :	January 2011

Groups and Cohorts

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Group/Cohort	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Clinical outcome [ Time Frame: approx. 90 days after stroke onset ]
   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 :

1. Angiographic outcome [ Time Frame: Day of intervention ]
   Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.
2. Complication rate [ Time Frame: within 36 h after endovascular procedure ]
   Periprocedural complication rate defined as a combination of symptomatic intracranial hemorrhage (ECASS classification PH I and PH II), subarachnoid hemorrhage and thrombembolic events.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	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)

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

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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

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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
First Posted:	July 22, 2011
Last Update Posted:	July 22, 2011
Last Verified:	July 2011

Keywords provided by Goethe University:

stroke, acute; mechanical recanalization; interventional neuroradiology; clinical registry

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases