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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Goethe University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Goethe University
ClinicalTrials.gov Identifier:
NCT01399762
First received: July 18, 2011
Last updated: July 21, 2011
Last verified: July 2011

July 18, 2011
July 21, 2011
January 2011
Not Provided
Clinical outcome [ Time Frame: approx. 90 days after stroke onset ] [ Designated as safety issue: No ]
Proportion of patients with favourable clinical outcome defined as a Modified Rankin Score (MRS) of 0,1, or 2 three months after the intervention.
Same as current
Complete list of historical versions of study NCT01399762 on ClinicalTrials.gov Archive Site
  • Angiographic outcome [ Time Frame: Day of intervention ] [ Designated as safety issue: No ]
    Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.
  • Complication rate [ Time Frame: within 36 h after endovascular procedure ] [ Designated as safety issue: Yes ]
    Periprocedural complication rate defined as a combination of symptomatic intracranial hemorrhage (ECASS classification PH I and PH II), subarachnoid hemorrhage and thrombembolic events.
Same as current
Not Provided
Not Provided
 
International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke
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.

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.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

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)

Acute Stroke
Device: mechanical recanalization
Endovascular thrombus extraction by mechanical recanalization devices
mechanical recanalization
Patients with acute stroke being treated with endovascular devices for mechanical recanalization (no restriction to specific endovascular devices)
Intervention: Device: mechanical recanalization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
Not Provided

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)
Both
18 Years and older
No
Contact: Oliver C Singer, MD +49 69 6301 5942 o.singer@em.uni-frankfurt.de
Contact: Joachim Berkefeld, MD +49 69 6301 5462 berkefeld@em.uni-frankfurt.de
Germany,   Austria
 
NCT01399762
Endostroke_01
Yes
PD Dr. med. Oliver C. Singer, Hirngefaesszentrum der Goethe Universitaet
Goethe University
Not Provided
Principal Investigator: Oliver C. Singer, MD Hirngefaesszentrum Goethe University Frankfurt Germany
Principal Investigator: Joachim Berkefeld, MD Hirngefaesszentrum Goethe University Frankfurt Germany
Goethe University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP