Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

Universität des Saarlandes40 enrolled

Overview

The objective of this study is to collect data on the use of the SOLITAIR FR device for treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether the application of SOLITAIR is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Stroke

Interventions

Solitaire FR, ev3DEVICE

Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-85 years * Acute ischemic stroke with occlusion if ICA, MCA, VA or BA (TICI 0 or 1 flow) within the first 6 hours Exclusion Criteria: * Rapidly improving neurological signs * NHISS\>30 or coma * Female patients, who are pregnant or lactating * Use of warfarin anticoagulation with INR \> 1.5 * Platelet count \< 30,000 * Glucose \< 50 mg/dL * Life expectancy of less than 90 days * Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation * CT showing hypodensity on presentation

Locations (1)

Department of diagnostic and interventional Neuroradiology

Homburg, Saarland, Germany

Outcomes

Primary Outcomes

Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)

Time frame: Day 90

Secondary Outcomes

Arterial recanalization of occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI)score of 2b or 3 following the use of the SOLITAIRE FR Device

Time frame: Day 0

Excellent functional clinical outcome (modified Rankin Scale 0 or 1)

Time frame: Day 90

All causes of mortality

Time frame: Day 90

Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment.

Time frame: Day 1

Symptomatic intracranial haemorrhages up to 24 hours after treatment defined as homogeneous areas of haemorrhage, with or without mass effect or intraventricular extension with neurological deterioration

Time frame: Day 1

Time between arterial puncture and Flow Restoration

Time frame: Day 0

Time between arterial puncture and TICI 2b or 3 recanalization

Time frame: Day 0

Number of SOLITAIRE device runs until recanalization

Time frame: Day 0

Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE

Data from ClinicalTrials.gov

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