International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke

Acute Stroke Clinical Trial

— ENDOSTROKE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01399762
• Other study ID #: Endostroke_01
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2011
• Last updated: July 21, 2011
• Start date: January 2011

Study information

• Verified date: July 2011
• Source: Goethe University
• Contact: Oliver C Singer, MD
• Phone: +49 69 6301 5942
• Email: o.singer[@]em.uni-frankfurt.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Device:
• mechanical recanalization
Endovascular thrombus extraction by mechanical recanalization devices

Locations

Country	Name	City	State
Austria	Departments of Neurology and Neuroradiology, University Hospital	Graz
Austria	Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg	Linz
Germany	Departments of Neurology and Neuroradiology, University Hospital	Aachen
Germany	Departments of Neurology and Radiology, Klinikum Altenburger Land	Altenburg
Germany	Departments of Neurology and Neuroradiology, Charite University Hospital	Berlin
Germany	Departments of Neurology and Neuroradiology, University Hospital	Duesseldorf
Germany	Departments of Neurology and Neuroradiology, University Hospital	Essen
Germany	Hirngefaesszentrum Goethe University	Frankfurt
Germany	Departments of Neurology and Neuroradiology, Klinikum Fulda	Fulda
Germany	Departments of Neurology and Neuroradiology, University Hospital	Giessen
Germany	Departments of Neurology and Neuroradiology, University Hospital	Kiel
Germany	Departments of Neurology and Neuroradiology, University Hospital	Mainz
Germany	Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus	Recklinghausen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approx. 90 days after stroke onset	No
Secondary	Angiographic outcome	Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.	Day of intervention	No
Secondary	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.	within 36 h after endovascular procedure	Yes