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<meta name="DC.Title" content="Cerebral intraarterial fibrinolysis at the crossroads: is a phase III trial advisable at this time?" />
<meta name="DC.Date" content="1994-08-01" />
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<meta name="DC.Description" content="PURPOSE To describe the rationale for fibrinolysis, review the state of the art in cerebral fibrinolysis, and discuss whether it is time for phase III studies of cerebral intraarterial fibrinolysis.

METHODS Critical review of the literature with statistical reevaluation of significant clinical data.

RESULTS There are abundant phase III data supporting the use of thrombolysis in the cardiovascular system. However, there are no published phase III trials of intraarterial fibrinolysis in stroke. All reports of cerebral intraarterial fibrinolysis are case series. The studies are typically small with variable treatment protocols and designs that are susceptible to bias. The only analysis comparing cerebral intraarterial fibrinolysis with conventional therapy is based on nonconcurrent controls.

CONCLUSIONS Stroke is common and costly. Acute stroke intervention with fibrinolytic drugs is theoretically justified. Studies done to date have significant, inferential limitations. The data suggest an association between thrombolysis, recanalization, and prognosis. However, imprecision and inadequate control of systematic error preclude conclusions regarding clinical outcomes. Randomized, controlled trials are needed to establish the clinical value of cerebral local intraarterial fibrinolysis. However, cerebral local intraarterial fibrinolysis availability, the cerebral local intraarterial arterial fibrinolysis learning curve, anticipated technological advances, unresolved procedural controversies, and ethical and fiscal considerations make a large phase III trial impractical and ill-advised at the present time. Additional basic research is needed to set the stage for a successful clinical trial." />
<meta name="DC.Contributor" content="R D Ferguson" />
<meta name="DC.Contributor" content="J G Ferguson" />
<meta name="article:published_time" content="1994-08-01" />
<meta name="citation_title" content="Cerebral intraarterial fibrinolysis at the crossroads: is a phase III trial advisable at this time?" />
<meta name="citation_abstract" lang="en" content="&lt;h3&gt;PURPOSE&lt;/h3&gt;
&lt;p&gt;To describe the rationale for fibrinolysis, review the state of the art in cerebral fibrinolysis, and discuss whether it is time for phase III studies of cerebral intraarterial fibrinolysis.&lt;/p&gt;&lt;h3&gt;METHODS&lt;/h3&gt;
&lt;p&gt;Critical review of the literature with statistical reevaluation of significant clinical data.&lt;/p&gt;&lt;h3&gt;RESULTS&lt;/h3&gt;
&lt;p&gt;There are abundant phase III data supporting the use of thrombolysis in the cardiovascular system. However, there are no published phase III trials of intraarterial fibrinolysis in stroke. All reports of cerebral intraarterial fibrinolysis are case series. The studies are typically small with variable treatment protocols and designs that are susceptible to bias. The only analysis comparing cerebral intraarterial fibrinolysis with conventional therapy is based on nonconcurrent controls.&lt;/p&gt;&lt;h3&gt;CONCLUSIONS&lt;/h3&gt;
&lt;p&gt;Stroke is common and costly. Acute stroke intervention with fibrinolytic drugs is theoretically justified. Studies done to date have significant, inferential limitations. The data suggest an association between thrombolysis, recanalization, and prognosis. However, imprecision and inadequate control of systematic error preclude conclusions regarding clinical outcomes. Randomized, controlled trials are needed to establish the clinical value of cerebral local intraarterial fibrinolysis. However, cerebral local intraarterial fibrinolysis availability, the cerebral local intraarterial arterial fibrinolysis learning curve, anticipated technological advances, unresolved procedural controversies, and ethical and fiscal considerations make a large phase III trial impractical and ill-advised at the present time. Additional basic research is needed to set the stage for a successful clinical trial.&lt;/p&gt;" />
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<meta name="citation_author" content="R D Ferguson" />
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<meta name="twitter:title" content="Cerebral intraarterial fibrinolysis at the crossroads: is a phase III trial advisable at this time?" />
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<meta name="twitter:description" content="PURPOSE To describe the rationale for fibrinolysis, review the state of the art in cerebral fibrinolysis, and discuss whether it is time for phase III studies of cerebral intraarterial fibrinolysis.

METHODS Critical review of the literature with statistical reevaluation of significant clinical data.

RESULTS There are abundant phase III data supporting the use of thrombolysis in the cardiovascular system. However, there are no published phase III trials of intraarterial fibrinolysis in stroke. All reports of cerebral intraarterial fibrinolysis are case series. The studies are typically small with variable treatment protocols and designs that are susceptible to bias. The only analysis comparing cerebral intraarterial fibrinolysis with conventional therapy is based on nonconcurrent controls.

CONCLUSIONS Stroke is common and costly. Acute stroke intervention with fibrinolytic drugs is theoretically justified. Studies done to date have significant, inferential limitations. The data suggest an association between thrombolysis, recanalization, and prognosis. However, imprecision and inadequate control of systematic error preclude conclusions regarding clinical outcomes. Randomized, controlled trials are needed to establish the clinical value of cerebral local intraarterial fibrinolysis. However, cerebral local intraarterial fibrinolysis availability, the cerebral local intraarterial arterial fibrinolysis learning curve, anticipated technological advances, unresolved procedural controversies, and ethical and fiscal considerations make a large phase III trial impractical and ill-advised at the present time. Additional basic research is needed to set the stage for a successful clinical trial." />
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<meta name="og-description" property="og:description" content="PURPOSE To describe the rationale for fibrinolysis, review the state of the art in cerebral fibrinolysis, and discuss whether it is time for phase III studies of cerebral intraarterial fibrinolysis.

METHODS Critical review of the literature with statistical reevaluation of significant clinical data.

RESULTS There are abundant phase III data supporting the use of thrombolysis in the cardiovascular system. However, there are no published phase III trials of intraarterial fibrinolysis in stroke. All reports of cerebral intraarterial fibrinolysis are case series. The studies are typically small with variable treatment protocols and designs that are susceptible to bias. The only analysis comparing cerebral intraarterial fibrinolysis with conventional therapy is based on nonconcurrent controls.

CONCLUSIONS Stroke is common and costly. Acute stroke intervention with fibrinolytic drugs is theoretically justified. Studies done to date have significant, inferential limitations. The data suggest an association between thrombolysis, recanalization, and prognosis. However, imprecision and inadequate control of systematic error preclude conclusions regarding clinical outcomes. Randomized, controlled trials are needed to establish the clinical value of cerebral local intraarterial fibrinolysis. However, cerebral local intraarterial fibrinolysis availability, the cerebral local intraarterial arterial fibrinolysis learning curve, anticipated technological advances, unresolved procedural controversies, and ethical and fiscal considerations make a large phase III trial impractical and ill-advised at the present time. Additional basic research is needed to set the stage for a successful clinical trial." />
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      <h1 class="highwire-cite-title" id="page-title">Cerebral intraarterial fibrinolysis at the crossroads: is a phase III trial advisable at this time?</h1>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0">R D Ferguson</span> and <span class="highwire-citation-author" data-delta="1">J G Ferguson</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">August 1994,  </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">15 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(7) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1201-1216; </span></div>
  
  
  
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<div id="hw-article-author-popups-top-node-6099--6661835257" style="display: none;"><div class="author-tooltip-0"><div class="author-tooltip-name">R D Ferguson </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'>Memphis Vascular Research Foundation, TN 38103.</div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=R%2BD%2BFerguson%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Ferguson%20RD&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AR%2BD%2BFerguson%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div><div class="author-tooltip-1"><div class="author-tooltip-name">J G Ferguson </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'>Memphis Vascular Research Foundation, TN 38103.</div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=J%2BG%2BFerguson%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Ferguson%20JG&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AJ%2BG%2BFerguson%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div></div></div>  </div>

  
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          <p id="p-1"><strong>PURPOSE</strong> To describe the rationale for fibrinolysis, review the state of the art in cerebral fibrinolysis, and discuss whether it is time for phase III studies of cerebral intraarterial fibrinolysis.</p>
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          <p id="p-2"><strong>METHODS</strong> Critical review of the literature with statistical reevaluation of significant clinical data.</p>
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          <p id="p-3"><strong>RESULTS</strong> There are abundant phase III data supporting the use of thrombolysis in the cardiovascular system. However, there are no published phase III trials of intraarterial fibrinolysis in stroke. All reports of cerebral intraarterial fibrinolysis are case series. The studies are typically small with variable treatment protocols and designs that are susceptible to bias. The only analysis comparing cerebral intraarterial fibrinolysis with conventional therapy is based on nonconcurrent controls.</p>
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          <p id="p-4"><strong>CONCLUSIONS</strong> Stroke is common and costly. Acute stroke intervention with fibrinolytic drugs is theoretically justified. Studies done to date have significant, inferential limitations. The data suggest an association between thrombolysis, recanalization, and prognosis. However, imprecision and inadequate control of systematic error preclude conclusions regarding clinical outcomes. Randomized, controlled trials are needed to establish the clinical value of cerebral local intraarterial fibrinolysis. However, cerebral local intraarterial fibrinolysis availability, the cerebral local intraarterial arterial fibrinolysis learning curve, anticipated technological advances, unresolved procedural controversies, and ethical and fiscal considerations make a large phase III trial impractical and ill-advised at the present time. Additional basic research is needed to set the stage for a successful clinical trial.</p>
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        	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-volume highwire-cite-metadata">Vol. 15</span>, <span  class="highwire-cite-metadata-issue highwire-cite-metadata">Issue 7 </span><div  class="highwire-cite-metadata-pubdate highwire-cite-metadata">1 Aug 1994 </div></div>
      
      
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      <div class="highwire-cite-title">Cerebral intraarterial fibrinolysis at the crossroads: is a phase III trial advisable at this time?</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 D</span> <span class="nlm-surname">Ferguson</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">J G</span> <span class="nlm-surname">Ferguson</span></span></span></div>
  
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    	<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 D</span> <span class="nlm-surname">Ferguson</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">J G</span> <span class="nlm-surname">Ferguson</span></span></span></div>
  
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