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

Primary Purpose

Acute Stroke

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Solitaire FR, ev3
Sponsored by
Universität des Saarlandes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring stroke, mechanical recanalization, self-expanding stent, Solitaire

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of diagnostic and interventional Neuroradiology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2010
Last Updated
December 1, 2011
Sponsor
Universität des Saarlandes
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1. Study Identification

Unique Protocol Identification Number
NCT01210729
Brief Title
Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke
Acronym
ReFlow
Official Title
Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universität des Saarlandes

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
stroke, mechanical recanalization, self-expanding stent, Solitaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Solitaire FR, ev3
Other Intervention Name(s)
device used: Solitaire FR, ev3, USA
Intervention Description
Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Excellent functional clinical outcome (modified Rankin Scale 0 or 1)
Time Frame
Day 90
Title
All causes of mortality
Time Frame
Day 90
Title
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
Title
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
Title
Time between arterial puncture and Flow Restoration
Time Frame
Day 0
Title
Time between arterial puncture and TICI 2b or 3 recanalization
Time Frame
Day 0
Title
Number of SOLITAIRE device runs until recanalization
Time Frame
Day 0
Title
Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE
Time Frame
Day 90
Title
Number of patients in which thrombus material was preserved
Time Frame
Day 0
Title
Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome
Time Frame
Day 1
Title
Overall frequency of modified Rankin Scale 0 to 2 at 30 days
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Reith, MD
Organizational Affiliation
Saarland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of diagnostic and interventional Neuroradiology
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20547941
Citation
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.
Results Reference
background
PubMed Identifier
20947848
Citation
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.
Results Reference
background
PubMed Identifier
22115640
Citation
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.
Results Reference
background
PubMed Identifier
21757666
Citation
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.
Results Reference
background
PubMed Identifier
23523460
Citation
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.
Results Reference
derived

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Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

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