Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

NCT01210729 | Completed Phase 2

• 1 other identifier: ReFlow01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Keywords

stroke; mechanical recanalization; self-expanding stent; Solitaire

Outcome Measures

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)

  Day 90

Secondary Outcomes (12)

• 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

• 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

Interventions

Solitaire FR, ev3 DEVICE

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

Also known as: device used: Solitaire FR, ev3, USA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Department of diagnostic and interventional Neuroradiology

Homburg, Saarland, 66424, Germany

Location

Related Publications (5)

• 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.

  PMID: 20547941 BACKGROUND

• 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.

  PMID: 20947848 BACKGROUND

• 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.

  PMID: 22115640 BACKGROUND

• 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.

  PMID: 21757666 BACKGROUND

• 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.

  PMID: 23523460 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wolfgang Reith, MD

  Saarland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 2, 2011

Record last verified: 2010-09

Locations

DE (1)