International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke "ENDOSTROKE"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Mechanical recanalization Device
    Intervention Desc: Endovascular thrombus extraction by mechanical recanalization devices
    ARM 1: Kind: Experimental
    Label: mechanical recanalization
    Description: Patients with acute stroke being treated with endovascular devices for mechanical recanalization (no restriction to specific endovascular devices)

Trial Design

  • Observation: Cohort
  • Sampling: Non-Probability Sample

Trial 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)

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical outcome approx. 90 days after stroke onset No
Secondary Angiographic outcome Day of intervention No
Secondary Complication rate within 36 h after endovascular procedure Yes

Sponsors