Clinical trial NCT01210729: Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke
Official title: Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Stroke
Keywords: stroke
mechanical recanalization
self-expanding stent
Solitaire
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)
timeFrame: Day 90
Secondary outcomes:
measure: 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
timeFrame: Day 0
measure: Excellent functional clinical outcome (modified Rankin Scale 0 or 1)
timeFrame: Day 90
measure: All causes of mortality
timeFrame: Day 90
measure: Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment.
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Time between arterial puncture and Flow Restoration
timeFrame: Day 0
measure: Time between arterial puncture and TICI 2b or 3 recanalization
timeFrame: Day 0
measure: Number of SOLITAIRE device runs until recanalization
timeFrame: Day 0
measure: Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE
timeFrame: Day 90
measure: Number of patients in which thrombus material was preserved
timeFrame: Day 0
measure: Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome
timeFrame: Day 1
measure: Overall frequency of modified Rankin Scale 0 to 2 at 30 days
timeFrame: Day 30
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of diagnostic and interventional Neuroradiology
state: Saarland
Study officials:
affiliation: Saarland University Hospital
name: Wolfgang Reith, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.