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<meta name="DC.Title" content="Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion Model" />
<meta name="DC.Identifier" content="10.3174/ajnr.A2169" />
<meta name="DC.Date" content="2010-11-01" />
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<meta name="DC.Description" content="BACKGROUND AND PURPOSE: The extended time window and theoretic reduction in hemorrhage make mechanical strategies an attractive approach in the treatment of patients with ischemic stroke. My purpose was to evaluate the recanalization efficacy and safety of the Solitaire FR Revascularization Device in a swine vessel occlusion model.

MATERIALS AND METHODS: For recanalization efficacy, radio-opaque clots were used in 6 ascending pharyngeal arteries of the swine. Safety was assessed in 8 renal arteries with 3 passes of the device. Four vessels were harvested at 30 days, and 4, at 90 days, with microscopic examination to assess vessel damage.

RESULTS: On deployment, immediate flow was seen in 3/6 vessels; and on retrieval, TIMI-3 recanalization was seen in 6/6. Vasospasm, which resolved on follow-up angiography with no distal emboli or vessel damage, was noted. In the renal vessels, safety evaluation findings were unremarkable, with the exception of 2 vessels harvested from a kidney at 90 days. These 2 vessels appeared without damage on microscopy; however, angiography showed shrinkage of the entire kidney, which was attributed to damage and stenosis of the main renal artery at the site of the guide-catheter insertion, likely leading to a chronic low-flow state and resultant atrophy of the entire kidney.

CONCLUSIONS: The Solitaire Device showed good recanalization efficacy with acceptable safety. The unique stent-like design allows immediate flow restoration, a distinct advantage of the device. On the basis of this study, the device has good potential as a tool in the treatment of patients with ischemic stroke.

A
:   artery
APA
:   ascending pharyngeal artery
FDA
:   US Food and Drug Administration
FR
:   flow restoration
L
:   left
MCA
:   middle cerebral artery
N/A
:   not applicable
R
:   right
Renal A
:   renal artery
TIMI
:   Thrombolysis In Myocardial Infarction
UCLA
:   University of California, Los Angeles" />
<meta name="DC.Contributor" content="R. Jahan" />
<meta name="article:published_time" content="2010-11-01" />
<meta name="article:section" content="Interventional" />
<meta name="citation_title" content="Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion Model" />
<meta name="citation_abstract" lang="en" content="&lt;h3&gt;BACKGROUND AND PURPOSE:&lt;/h3&gt;
&lt;p&gt;The extended time window and theoretic reduction in hemorrhage make mechanical strategies an attractive approach in the treatment of patients with ischemic stroke. My purpose was to evaluate the recanalization efficacy and safety of the Solitaire FR Revascularization Device in a swine vessel occlusion model.&lt;/p&gt;&lt;h3&gt;MATERIALS AND METHODS:&lt;/h3&gt;
&lt;p&gt;For recanalization efficacy, radio-opaque clots were used in 6 ascending pharyngeal arteries of the swine. Safety was assessed in 8 renal arteries with 3 passes of the device. Four vessels were harvested at 30 days, and 4, at 90 days, with microscopic examination to assess vessel damage.&lt;/p&gt;&lt;h3&gt;RESULTS:&lt;/h3&gt;
&lt;p&gt;On deployment, immediate flow was seen in 3/6 vessels; and on retrieval, TIMI-3 recanalization was seen in 6/6. Vasospasm, which resolved on follow-up angiography with no distal emboli or vessel damage, was noted. In the renal vessels, safety evaluation findings were unremarkable, with the exception of 2 vessels harvested from a kidney at 90 days. These 2 vessels appeared without damage on microscopy; however, angiography showed shrinkage of the entire kidney, which was attributed to damage and stenosis of the main renal artery at the site of the guide-catheter insertion, likely leading to a chronic low-flow state and resultant atrophy of the entire kidney.&lt;/p&gt;&lt;h3&gt;CONCLUSIONS:&lt;/h3&gt;
&lt;p&gt;The Solitaire Device showed good recanalization efficacy with acceptable safety. The unique stent-like design allows immediate flow restoration, a distinct advantage of the device. On the basis of this study, the device has good potential as a tool in the treatment of patients with ischemic stroke.&lt;/p&gt;" />
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<meta name="twitter:title" content="Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion Model" />
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<meta name="twitter:description" content="BACKGROUND AND PURPOSE: The extended time window and theoretic reduction in hemorrhage make mechanical strategies an attractive approach in the treatment of patients with ischemic stroke. My purpose was to evaluate the recanalization efficacy and safety of the Solitaire FR Revascularization Device in a swine vessel occlusion model.

MATERIALS AND METHODS: For recanalization efficacy, radio-opaque clots were used in 6 ascending pharyngeal arteries of the swine. Safety was assessed in 8 renal arteries with 3 passes of the device. Four vessels were harvested at 30 days, and 4, at 90 days, with microscopic examination to assess vessel damage.

RESULTS: On deployment, immediate flow was seen in 3/6 vessels; and on retrieval, TIMI-3 recanalization was seen in 6/6. Vasospasm, which resolved on follow-up angiography with no distal emboli or vessel damage, was noted. In the renal vessels, safety evaluation findings were unremarkable, with the exception of 2 vessels harvested from a kidney at 90 days. These 2 vessels appeared without damage on microscopy; however, angiography showed shrinkage of the entire kidney, which was attributed to damage and stenosis of the main renal artery at the site of the guide-catheter insertion, likely leading to a chronic low-flow state and resultant atrophy of the entire kidney.

CONCLUSIONS: The Solitaire Device showed good recanalization efficacy with acceptable safety. The unique stent-like design allows immediate flow restoration, a distinct advantage of the device. On the basis of this study, the device has good potential as a tool in the treatment of patients with ischemic stroke.

A
:   artery
APA
:   ascending pharyngeal artery
FDA
:   US Food and Drug Administration
FR
:   flow restoration
L
:   left
MCA
:   middle cerebral artery
N/A
:   not applicable
R
:   right
Renal A
:   renal artery
TIMI
:   Thrombolysis In Myocardial Infarction
UCLA
:   University of California, Los Angeles" />
<meta name="og-title" property="og:title" content="Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion Model" />
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<meta name="og-description" property="og:description" content="BACKGROUND AND PURPOSE: The extended time window and theoretic reduction in hemorrhage make mechanical strategies an attractive approach in the treatment of patients with ischemic stroke. My purpose was to evaluate the recanalization efficacy and safety of the Solitaire FR Revascularization Device in a swine vessel occlusion model.

MATERIALS AND METHODS: For recanalization efficacy, radio-opaque clots were used in 6 ascending pharyngeal arteries of the swine. Safety was assessed in 8 renal arteries with 3 passes of the device. Four vessels were harvested at 30 days, and 4, at 90 days, with microscopic examination to assess vessel damage.

RESULTS: On deployment, immediate flow was seen in 3/6 vessels; and on retrieval, TIMI-3 recanalization was seen in 6/6. Vasospasm, which resolved on follow-up angiography with no distal emboli or vessel damage, was noted. In the renal vessels, safety evaluation findings were unremarkable, with the exception of 2 vessels harvested from a kidney at 90 days. These 2 vessels appeared without damage on microscopy; however, angiography showed shrinkage of the entire kidney, which was attributed to damage and stenosis of the main renal artery at the site of the guide-catheter insertion, likely leading to a chronic low-flow state and resultant atrophy of the entire kidney.

CONCLUSIONS: The Solitaire Device showed good recanalization efficacy with acceptable safety. The unique stent-like design allows immediate flow restoration, a distinct advantage of the device. On the basis of this study, the device has good potential as a tool in the treatment of patients with ischemic stroke.

A
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APA
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FDA
:   US Food and Drug Administration
FR
:   flow restoration
L
:   left
MCA
:   middle cerebral artery
N/A
:   not applicable
R
:   right
Renal A
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TIMI
:   Thrombolysis In Myocardial Infarction
UCLA
:   University of California, Los Angeles" />
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      <h1 class="highwire-cite-title" id="page-title">Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion Model</h1>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0">R. Jahan</span></span></div>
  
    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">November 2010,  </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">31 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(10) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1938-1943; </span><span  class="highwire-cite-metadata-doi highwire-cite-metadata">DOI: https://doi.org/10.3174/ajnr.A2169 </span></div>
  
  
  
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<p id="p-1"><strong>BACKGROUND AND PURPOSE:</strong> The extended time window and theoretic reduction in hemorrhage make mechanical strategies an attractive approach in the treatment of patients with ischemic stroke. My purpose was to evaluate the recanalization efficacy and safety of the Solitaire FR Revascularization Device in a swine vessel occlusion model.</p>
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<p id="p-2"><strong>MATERIALS AND METHODS:</strong> For recanalization efficacy, radio-opaque clots were used in 6 ascending pharyngeal arteries of the swine. Safety was assessed in 8 renal arteries with 3 passes of the device. Four vessels were harvested at 30 days, and 4, at 90 days, with microscopic examination to assess vessel damage.</p>
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<p id="p-3"><strong>RESULTS:</strong> On deployment, immediate flow was seen in 3/6 vessels; and on retrieval, TIMI-3 recanalization was seen in 6/6. Vasospasm, which resolved on follow-up angiography with no distal emboli or vessel damage, was noted. In the renal vessels, safety evaluation findings were unremarkable, with the exception of 2 vessels harvested from a kidney at 90 days. These 2 vessels appeared without damage on microscopy; however, angiography showed shrinkage of the entire kidney, which was attributed to damage and stenosis of the main renal artery at the site of the guide-catheter insertion, likely leading to a chronic low-flow state and resultant atrophy of the entire kidney.</p>
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<p id="p-4"><strong>CONCLUSIONS:</strong> The Solitaire Device showed good recanalization efficacy with acceptable safety. The unique stent-like design allows immediate flow restoration, a distinct advantage of the device. On the basis of this study, the device has good potential as a tool in the treatment of patients with ischemic stroke.</p>
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</div><div class="section glossary" id="glossary-1"><h2>Abbreviations</h2><dl id="def-list-1"><dt id="def-item-1">A<span class="def-item-dt-sep"></span></dt><dd>artery<span class="def-item-dd-sep"></span></dd><dt id="def-item-2">APA<span class="def-item-dt-sep"></span></dt><dd>ascending pharyngeal artery<span class="def-item-dd-sep"></span></dd><dt id="def-item-3">FDA<span class="def-item-dt-sep"></span></dt><dd>US Food and Drug Administration<span class="def-item-dd-sep"></span></dd><dt id="def-item-4">FR<span class="def-item-dt-sep"></span></dt><dd>flow restoration<span class="def-item-dd-sep"></span></dd><dt id="def-item-5">L<span class="def-item-dt-sep"></span></dt><dd>left<span class="def-item-dd-sep"></span></dd><dt id="def-item-6">MCA<span class="def-item-dt-sep"></span></dt><dd>middle cerebral artery<span class="def-item-dd-sep"></span></dd><dt id="def-item-7">N/A<span class="def-item-dt-sep"></span></dt><dd>not applicable<span class="def-item-dd-sep"></span></dd><dt id="def-item-8">R<span class="def-item-dt-sep"></span></dt><dd>right<span class="def-item-dd-sep"></span></dd><dt id="def-item-9">Renal A<span class="def-item-dt-sep"></span></dt><dd>renal artery<span class="def-item-dd-sep"></span></dd><dt id="def-item-10">TIMI<span class="def-item-dt-sep"></span></dt><dd>Thrombolysis In Myocardial Infarction<span class="def-item-dd-sep"></span></dd><dt id="def-item-11">UCLA<span class="def-item-dt-sep"></span></dt><dd>University of California, Los Angeles</dd></dl></div><ul class="copyright-statement"><li class="fn" id="copyright-statement-1">Copyright © American Society of Neuroradiology</li></ul><span class="highwire-journal-article-marker-end"></span></div><span class="related-urls"></span></div><a href="http://ajnr-stage2.stage.highwire.org/content/31/10/1938.full" class="hw-link hw-link-article-full-text" data-icon-position="" data-hide-link-title="0">View Full Text</a></div>  </div>

  
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      <div class="highwire-cite-title">Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion Model</div>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0"><span class="nlm-given-names">R.</span> <span class="nlm-surname">Jahan</span></span></span></div>
  
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      <div class="highwire-cite-title">Solitaire Flow-Restoration Device for Treatment of Acute Ischemic Stroke: Safety and Recanalization Efficacy Study in a Swine Vessel Occlusion Model</div>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0"><span class="nlm-given-names">R.</span> <span class="nlm-surname">Jahan</span></span></span></div>
  
    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">Nov 2010, </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">31 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(10) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1938-1943; </span><span  class="highwire-cite-metadata-doi highwire-cite-metadata"><span class="label">DOI:</span> 10.3174/ajnr.A2169 </span></div>
  
  
  
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