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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Stroke
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Departments of Neurology and Neuroradiology, University Hospital
  • Linz, Austria, 4020
    • Recruiting
    • Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg
• Germany
  • Aachen, Germany, 52074
    • Active, not recruiting
    • Departments of Neurology and Neuroradiology, University Hospital
  • Altenburg, Germany, 04600
    • Not yet recruiting
    • Departments of Neurology and Radiology, Klinikum Altenburger Land
  • Berlin, Germany, 10117
    • Recruiting
    • Departments of Neurology and Neuroradiology, Charite University Hospital
  • Duesseldorf, Germany, 40255
    • Active, not recruiting
    • Departments of Neurology and Neuroradiology, University Hospital
  • Essen, Germany, 45122
    • Recruiting
    • Departments of Neurology and Neuroradiology, University Hospital
  • Frankfurt, Germany, 60528
    • Recruiting
    • Hirngefaesszentrum Goethe University
  • Fulda, Germany, 36043
    • Recruiting
    • Departments of Neurology and Neuroradiology, Klinikum Fulda
  • Giessen, Germany, 35385
    • Active, not recruiting
    • Departments of Neurology and Neuroradiology, University Hospital
  • Kiel, Germany, 24105
    • Active, not recruiting
    • Departments of Neurology and Neuroradiology, University Hospital
  • Mainz, Germany, 55131
    • Active, not recruiting
    • Departments of Neurology and Neuroradiology, University Hospital
  • Recklinghausen, Germany, 45657
    • Active, not recruiting
    • Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic outcome	Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.	Day of intervention
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

Collaborators and Investigators

• Sponsor: Goethe University
• Investigators: Principal Investigator: Oliver C. Singer, MD, Hirngefaesszentrum Goethe University Frankfurt Germany; Principal Investigator: Joachim Berkefeld, MD, Hirngefaesszentrum Goethe University Frankfurt Germany

Study record dates

Study Major Dates

• Study Start: January 1, 2011

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: interventional neuroradiology; stroke, acute; mechanical recanalization; clinical registry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Endostroke_01