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

July 21, 2011 updated by: Goethe University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: 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.
approx. 90 days after stroke onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Angiographic outcome
Time Frame: Day of intervention
Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.
Day of intervention
Complication rate
Time Frame: 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.
within 36 h after endovascular procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oliver C. Singer, MD, Hirngefaesszentrum Goethe University Frankfurt Germany
  • Principal Investigator: Joachim Berkefeld, MD, Hirngefaesszentrum Goethe University Frankfurt Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Endostroke_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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