International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke

NCT ID: NCT01399762

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31

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.

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.

Conditions

Acute Stroke

Study Design

• Observational Model Type: COHORT

Study Groups

mechanical recanalization

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

mechanical recanalization

Intervention Type: DEVICE

Endovascular thrombus extraction by mechanical recanalization devices

Interventions

mechanical recanalization

Endovascular thrombus extraction by mechanical recanalization devices

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Hirngefaesszentrum der Goethe Universitaet

Principal Investigators

Oliver C. Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Hirngefaesszentrum Goethe University Frankfurt Germany

Joachim Berkefeld, MD

Role: PRINCIPAL_INVESTIGATOR

Hirngefaesszentrum Goethe University Frankfurt Germany

Locations

Departments of Neurology and Neuroradiology, University Hospital

Graz, , Austria

Site Status: RECRUITING

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

Linz, , Austria

Site Status: RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Aachen, , Germany

Site Status: ACTIVE_NOT_RECRUITING

Departments of Neurology and Radiology, Klinikum Altenburger Land

Altenburg, , Germany

Site Status: NOT_YET_RECRUITING

Departments of Neurology and Neuroradiology, Charite University Hospital

Berlin, , Germany

Site Status: RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Düsseldorf, , Germany

Site Status: ACTIVE_NOT_RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Essen, , Germany

Site Status: RECRUITING

Hirngefaesszentrum Goethe University

Frankfurt, , Germany

Site Status: RECRUITING

Departments of Neurology and Neuroradiology, Klinikum Fulda

Fulda, , Germany

Site Status: RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Giessen, , Germany

Site Status: ACTIVE_NOT_RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Kiel, , Germany

Site Status: ACTIVE_NOT_RECRUITING

Departments of Neurology and Neuroradiology, University Hospital

Mainz, , Germany

Site Status: ACTIVE_NOT_RECRUITING

Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus

Recklinghausen, , Germany

Site Status: ACTIVE_NOT_RECRUITING

Countries

Austria; Germany

Central Contacts

Oliver C Singer, MD

Role: CONTACT

o.singer@em.uni-frankfurt.de

+49 69 6301 5942

Joachim Berkefeld, MD

Role: CONTACT

berkefeld@em.uni-frankfurt.de

+49 69 6301 5462

Other Identifiers

Endostroke_01

Identifier Type: -

Identifier Source: org_study_id