International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke

• Conditions: Acute Stroke
• Interventions: Device: mechanical recanalization

• Registration Number: NCT01399762
• Lead Sponsor: Goethe University

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.

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical outcome	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

Name	Time	Method
Angiographic outcome	Day of intervention	Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.
Complication rate	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.

Trial Locations

Locations (7)

Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg; 🇦🇹 Linz, Austria

Hirngefaesszentrum Goethe University; 🇩🇪 Frankfurt, Germany

Departments of Neurology and Radiology, Klinikum Altenburger Land; 🇩🇪 Altenburg, Germany

Departments of Neurology and Neuroradiology, Klinikum Fulda; 🇩🇪 Fulda, Germany

Departments of Neurology and Neuroradiology, Charite University Hospital; 🇩🇪 Berlin, Germany

Departments of Neurology and Neuroradiology, University Hospital; 🇩🇪 Mainz, Germany

Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus; 🇩🇪 Recklinghausen, Germany