Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Acute Stroke

• Registration Number: NCT01210729
• Lead Sponsor: Universität des Saarlandes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-12-01
• Last Update Posted: 2011-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)	Day 90

Secondary Outcome Measures

Name	Time	Method
Excellent functional clinical outcome (modified Rankin Scale 0 or 1)	Day 90
All causes of mortality	Day 90
Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment.	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	Day 1
Time between arterial puncture and Flow Restoration	Day 0
Time between arterial puncture and TICI 2b or 3 recanalization	Day 0
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	Day 0
Number of SOLITAIRE device runs until recanalization	Day 0
Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE	Day 90
Number of patients in which thrombus material was preserved	Day 0
Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome	Day 1
Overall frequency of modified Rankin Scale 0 to 2 at 30 days	Day 30

Trial Locations

Locations (1)

Department of diagnostic and interventional Neuroradiology; 🇩🇪 Homburg, Saarland, Germany