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

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

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 Overview

• Status: Completed
• Conditions: Acute Stroke
• Intervention / Treatment: Device: Solitaire FR, ev3

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66424
      • Department of Diagnostic and Interventional Neuroradiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
All causes of mortality	Day 90
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
Excellent functional clinical outcome (modified Rankin Scale 0 or 1)	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
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

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Investigators: Principal Investigator: Wolfgang Reith, MD, Saarland University Hospital

Publications and helpful links

General Publications

• Papanagiotou P, Roth C, Walter S, Behnke S, Politi M, Fassbender K, Haass A, Reith W. Treatment of acute cerebral artery occlusion with a fully recoverable intracranial stent: a new technique. Circulation. 2010 Jun 15;121(23):2605-6. doi: 10.1161/CIRCULATIONAHA.110.948166. No abstract available.
• Roth C, Papanagiotou P, Behnke S, Walter S, Haass A, Becker C, Fassbender K, Politi M, Korner H, Romann MS, Reith W. Stent-assisted mechanical recanalization for treatment of acute intracerebral artery occlusions. Stroke. 2010 Nov;41(11):2559-67. doi: 10.1161/STROKEAHA.110.592071. Epub 2010 Oct 14.
• Papanagiotou P, Roth C, Walter S, Behnke S, Grunwald IQ, Viera J, Politi M, Korner H, Kostopoulos P, Haass A, Fassbender K, Reith W. Carotid artery stenting in acute stroke. J Am Coll Cardiol. 2011 Nov 29;58(23):2363-9. doi: 10.1016/j.jacc.2011.08.044.
• Papanagiotou P, Roth C, Reith W. Letter by Papanagiotou et Al regarding article, "percutaneous vascular interventions for acute ischemic stroke". Stroke. 2011 Sep;42(9):e545; author reply e546. doi: 10.1161/STROKEAHA.111.620989. Epub 2011 Jul 14. No abstract available.
• Roth C, Reith W, Walter S, Behnke S, Kettner M, Viera J, Yilmaz U, Alexandrou M, Politi M, Kostopoulos P, Korner H, Krick C, Haass A, Fassbender K, Papanagiotou P. Mechanical recanalization with flow restoration in acute ischemic stroke: the ReFlow (mechanical recanalization with flow restoration in acute ischemic stroke) study. JACC Cardiovasc Interv. 2013 Apr;6(4):386-91. doi: 10.1016/j.jcin.2012.11.013. Epub 2013 Mar 20.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 27, 2010
• First Posted (Estimate): September 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 2, 2011
• Last Update Submitted That Met QC Criteria: December 1, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: stroke; self-expanding stent; Solitaire; mechanical recanalization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: ReFlow01