Clinical trial NCT01399762: International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke
Official title: International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Keywords: stroke, acute
mechanical recanalization
interventional neuroradiology
clinical registry
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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)

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.

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)

Primary outcomes:
measure: Clinical outcome
timeFrame: approx. 90 days after stroke onset
Secondary outcomes:
measure: Angiographic outcome
timeFrame: Day of intervention
measure: Complication rate
timeFrame: within 36 h after endovascular procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Departments of Neurology and Neuroradiology, University Hospital
city: Linz
country: Austria
facility: Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg
city: Aachen
country: Germany
facility: Departments of Neurology and Neuroradiology, University Hospital
city: Altenburg
country: Germany
facility: Departments of Neurology and Radiology, Klinikum Altenburger Land
city: Berlin
country: Germany
facility: Departments of Neurology and Neuroradiology, Charite University Hospital
city: Duesseldorf
country: Germany
facility: Departments of Neurology and Neuroradiology, University Hospital
city: Essen
country: Germany
facility: Departments of Neurology and Neuroradiology, University Hospital
city: Frankfurt
country: Germany
facility: Hirngefaesszentrum Goethe University
city: Fulda
country: Germany
facility: Departments of Neurology and Neuroradiology, Klinikum Fulda
city: Giessen
country: Germany
facility: Departments of Neurology and Neuroradiology, University Hospital
city: Kiel
country: Germany
facility: Departments of Neurology and Neuroradiology, University Hospital
city: Mainz
country: Germany
facility: Departments of Neurology and Neuroradiology, University Hospital
city: Recklinghausen
country: Germany
facility: Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus
Study officials:
affiliation: Hirngefaesszentrum Goethe University Frankfurt Germany
name: Oliver C. Singer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hirngefaesszentrum Goethe University Frankfurt Germany
name: Joachim Berkefeld, MD
role: PRINCIPAL_INVESTIGATOR
References: