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Completed

NCT Number: NCT01210729

Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of diagnostic and interventional Neuroradiology

Homburg, Saarland, 66424, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solitaire FR, ev3

Device

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

Other names: device used: Solitaire FR, ev3, USA

Primary outcomes

  1. 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

  1. 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

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

    Time frame: Day 90

  3. All causes of mortality

    Time frame: Day 90

  4. 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

  5. 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

  6. Time between arterial puncture and Flow Restoration

    Time frame: Day 0

  7. Time between arterial puncture and TICI 2b or 3 recanalization

    Time frame: Day 0

  8. Number of SOLITAIRE device runs until recanalization

    Time frame: Day 0

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

    Time frame: Day 90

  10. Number of patients in which thrombus material was preserved

    Time frame: Day 0

  11. Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome

    Time frame: Day 1

  12. Overall frequency of modified Rankin Scale 0 to 2 at 30 days

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study title

Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow Study)

Acronym: ReFlow

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2010
Registry last updated
Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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