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Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

NCT ID: NCT01210729

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Stroke

Keywords

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stroke mechanical recanalization self-expanding stent Solitaire

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Solitaire FR, ev3

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

Intervention Type DEVICE

Other Intervention Names

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device used: Solitaire FR, ev3, USA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Department of diagnostic and interventional Neuroradiology, Saarland University Hospital

Principal Investigators

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Wolfgang Reith, MD

Role: PRINCIPAL_INVESTIGATOR

Saarland University Hospital

Locations

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Department of diagnostic and interventional Neuroradiology

Homburg, Saarland, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 20547941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20947848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22115640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21757666 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23523460 (View on PubMed)

Other Identifiers

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ReFlow01

Identifier Type: -

Identifier Source: org_study_id