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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solitaire FR, ev3 | Device | Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Reith, MD | Saarland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of diagnostic and interventional Neuroradiology | Homburg | Saarland | 66424 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20547941 | Background | 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. | |
| 20947848 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| 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 |
| 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. |
| 22115640 | 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. |
| 21757666 | 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. |
| 23523460 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |