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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01210729
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : December 2, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Stroke Device: Solitaire FR, ev3 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow Study)
Study Start Date : September 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011
Arms and Interventions

Intervention Details:
    Device: Solitaire FR, ev3
    Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.
    Other Name: device used: Solitaire FR, ev3, USA

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210729


Locations
Germany
Department of diagnostic and interventional Neuroradiology
Homburg, Saarland, Germany, 66424
Sponsors and Collaborators
Saarland University
Investigators
Principal Investigator: Wolfgang Reith, MD Saarland University Hospital
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Wolfgang Reith, Department of diagnostic and interventional Neuroradiology, Saarland University Hospital
ClinicalTrials.gov Identifier: NCT01210729     History of Changes
Other Study ID Numbers: ReFlow01
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: September 2010

Keywords provided by Saarland University:
stroke
mechanical recanalization
self-expanding stent
Solitaire

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases