Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial
Purpose: A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high‐risk features for carotid endarterectomy was conducted during the 3‐month period from March to May 2005. Methods: Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Pr...
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| Veröffentlicht in: | Journal of interventional cardiology 2010-10, Vol.23 (5), p.491-498 |
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| container_title | Journal of interventional cardiology |
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| creator | SAFIAN, ROBERT D. JAFF, MICHAEL R. BRESNAHAN, JOHN F. FOSTER, MALCOLM BACHARACH, J. MICHAEL YADAV, JAY JOYE, JAMES MYLA, SUBBARAO KASSAB, ELIAS MANN, J. TIFT ANSEL, GARY M. |
| description | Purpose:
A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high‐risk features for carotid endarterectomy was conducted during the 3‐month period from March to May 2005.
Methods:
Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration.
Results:
The primary end‐point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end‐point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis |
| doi_str_mv | 10.1111/j.1540-8183.2010.00578.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_762471428</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>762471428</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4068-5879d5dcf1cc353a79cfe5e9288bbc18384d098ead8c778917e3920c3a7aa9133</originalsourceid><addsrcrecordid>eNqNkd9u2yAUxtG0ac26vcLE3a6cYbADnrSLzuu_qVqrNFN7hwg-TkgdkwFOkz5Kn3a4aXI9LuDonN93kL4PIZySYRrP18UwzTOSiFSwISWxS0jOxXDzBg0Og7doQEQxSjJG-RH64P2CEErynL5HR5SMaBavAXq-cTaADlDhUsXSVPg2QBtMO8OmxRdmNk_Gxj_gGxVM7PtveAy-a4LHtsZhDvh2ZSoY3-MTt9y39pvGsFZed41y5inKbYsfTZhjWLNIB3BGNXgCet7axs62-HRtm-4Fm_Sjj-hdrRoPn17fY_Tn7HRSXiRX1-eX5clVojMyEkkueFHlla5TrVnOFC90DTkUVIjpVEcjRFaRQoCqhOZcFCkHVlCiI6lUkTJ2jL7s9q6c_duBD3JpvIamUS3YzkseveJpRkUkxY7UznrvoJYrZ5bKbWVKZB-MXMjef9n7L_tg5EswchOln18_6aZLqA7CfRIR-L4DHk0D2_9eLH9dX5axivpkpzc-wOagV-5Bjjjjubz7fS5Llt3dZz9_yDP2D2wErUc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>762471428</pqid></control><display><type>article</type><title>Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>SAFIAN, ROBERT D. ; JAFF, MICHAEL R. ; BRESNAHAN, JOHN F. ; FOSTER, MALCOLM ; BACHARACH, J. MICHAEL ; YADAV, JAY ; JOYE, JAMES ; MYLA, SUBBARAO ; KASSAB, ELIAS ; MANN, J. TIFT ; ANSEL, GARY M.</creator><creatorcontrib>SAFIAN, ROBERT D. ; JAFF, MICHAEL R. ; BRESNAHAN, JOHN F. ; FOSTER, MALCOLM ; BACHARACH, J. MICHAEL ; YADAV, JAY ; JOYE, JAMES ; MYLA, SUBBARAO ; KASSAB, ELIAS ; MANN, J. TIFT ; ANSEL, GARY M. ; CREATE SpideRX Trial Investigators ; on behalf of the CREATE SpideRX Trial Investigators</creatorcontrib><description>Purpose:
A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high‐risk features for carotid endarterectomy was conducted during the 3‐month period from March to May 2005.
Methods:
Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration.
Results:
The primary end‐point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end‐point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05).
Conclusion:
CAS with distal embolic protection using the SpideRX™ Embolic Protection System is a reasonable alternative for revascularization of some high‐risk patients with severe carotid stenosis. (J Interven Cardiol 2010;23:491–498)</description><identifier>ISSN: 0896-4327</identifier><identifier>EISSN: 1540-8183</identifier><identifier>DOI: 10.1111/j.1540-8183.2010.00578.x</identifier><identifier>PMID: 20624206</identifier><language>eng</language><publisher>Malden, USA: Blackwell Publishing Inc</publisher><subject>Aged ; Aged, 80 and over ; Angioplasty, Balloon, Coronary - methods ; Carotid Arteries - pathology ; Carotid Stenosis - pathology ; Carotid Stenosis - prevention & control ; Carotid Stenosis - therapy ; Confidence Intervals ; Feasibility Studies ; Female ; Humans ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Prospective Studies ; Registries ; Risk Factors ; Stents</subject><ispartof>Journal of interventional cardiology, 2010-10, Vol.23 (5), p.491-498</ispartof><rights>2010, Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4068-5879d5dcf1cc353a79cfe5e9288bbc18384d098ead8c778917e3920c3a7aa9133</citedby><cites>FETCH-LOGICAL-c4068-5879d5dcf1cc353a79cfe5e9288bbc18384d098ead8c778917e3920c3a7aa9133</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20624206$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>SAFIAN, ROBERT D.</creatorcontrib><creatorcontrib>JAFF, MICHAEL R.</creatorcontrib><creatorcontrib>BRESNAHAN, JOHN F.</creatorcontrib><creatorcontrib>FOSTER, MALCOLM</creatorcontrib><creatorcontrib>BACHARACH, J. MICHAEL</creatorcontrib><creatorcontrib>YADAV, JAY</creatorcontrib><creatorcontrib>JOYE, JAMES</creatorcontrib><creatorcontrib>MYLA, SUBBARAO</creatorcontrib><creatorcontrib>KASSAB, ELIAS</creatorcontrib><creatorcontrib>MANN, J. TIFT</creatorcontrib><creatorcontrib>ANSEL, GARY M.</creatorcontrib><creatorcontrib>CREATE SpideRX Trial Investigators</creatorcontrib><creatorcontrib>on behalf of the CREATE SpideRX Trial Investigators</creatorcontrib><title>Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial</title><title>Journal of interventional cardiology</title><addtitle>J Interv Cardiol</addtitle><description>Purpose:
A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high‐risk features for carotid endarterectomy was conducted during the 3‐month period from March to May 2005.
Methods:
Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration.
Results:
The primary end‐point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end‐point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05).
Conclusion:
CAS with distal embolic protection using the SpideRX™ Embolic Protection System is a reasonable alternative for revascularization of some high‐risk patients with severe carotid stenosis. (J Interven Cardiol 2010;23:491–498)</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angioplasty, Balloon, Coronary - methods</subject><subject>Carotid Arteries - pathology</subject><subject>Carotid Stenosis - pathology</subject><subject>Carotid Stenosis - prevention & control</subject><subject>Carotid Stenosis - therapy</subject><subject>Confidence Intervals</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Humans</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multivariate Analysis</subject><subject>Odds Ratio</subject><subject>Prospective Studies</subject><subject>Registries</subject><subject>Risk Factors</subject><subject>Stents</subject><issn>0896-4327</issn><issn>1540-8183</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkd9u2yAUxtG0ac26vcLE3a6cYbADnrSLzuu_qVqrNFN7hwg-TkgdkwFOkz5Kn3a4aXI9LuDonN93kL4PIZySYRrP18UwzTOSiFSwISWxS0jOxXDzBg0Og7doQEQxSjJG-RH64P2CEErynL5HR5SMaBavAXq-cTaADlDhUsXSVPg2QBtMO8OmxRdmNk_Gxj_gGxVM7PtveAy-a4LHtsZhDvh2ZSoY3-MTt9y39pvGsFZed41y5inKbYsfTZhjWLNIB3BGNXgCet7axs62-HRtm-4Fm_Sjj-hdrRoPn17fY_Tn7HRSXiRX1-eX5clVojMyEkkueFHlla5TrVnOFC90DTkUVIjpVEcjRFaRQoCqhOZcFCkHVlCiI6lUkTJ2jL7s9q6c_duBD3JpvIamUS3YzkseveJpRkUkxY7UznrvoJYrZ5bKbWVKZB-MXMjef9n7L_tg5EswchOln18_6aZLqA7CfRIR-L4DHk0D2_9eLH9dX5axivpkpzc-wOagV-5Bjjjjubz7fS5Llt3dZz9_yDP2D2wErUc</recordid><startdate>201010</startdate><enddate>201010</enddate><creator>SAFIAN, ROBERT D.</creator><creator>JAFF, MICHAEL R.</creator><creator>BRESNAHAN, JOHN F.</creator><creator>FOSTER, MALCOLM</creator><creator>BACHARACH, J. MICHAEL</creator><creator>YADAV, JAY</creator><creator>JOYE, JAMES</creator><creator>MYLA, SUBBARAO</creator><creator>KASSAB, ELIAS</creator><creator>MANN, J. TIFT</creator><creator>ANSEL, GARY M.</creator><general>Blackwell Publishing Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201010</creationdate><title>Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial</title><author>SAFIAN, ROBERT D. ; JAFF, MICHAEL R. ; BRESNAHAN, JOHN F. ; FOSTER, MALCOLM ; BACHARACH, J. MICHAEL ; YADAV, JAY ; JOYE, JAMES ; MYLA, SUBBARAO ; KASSAB, ELIAS ; MANN, J. TIFT ; ANSEL, GARY M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4068-5879d5dcf1cc353a79cfe5e9288bbc18384d098ead8c778917e3920c3a7aa9133</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Angioplasty, Balloon, Coronary - methods</topic><topic>Carotid Arteries - pathology</topic><topic>Carotid Stenosis - pathology</topic><topic>Carotid Stenosis - prevention & control</topic><topic>Carotid Stenosis - therapy</topic><topic>Confidence Intervals</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Humans</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multivariate Analysis</topic><topic>Odds Ratio</topic><topic>Prospective Studies</topic><topic>Registries</topic><topic>Risk Factors</topic><topic>Stents</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>SAFIAN, ROBERT D.</creatorcontrib><creatorcontrib>JAFF, MICHAEL R.</creatorcontrib><creatorcontrib>BRESNAHAN, JOHN F.</creatorcontrib><creatorcontrib>FOSTER, MALCOLM</creatorcontrib><creatorcontrib>BACHARACH, J. MICHAEL</creatorcontrib><creatorcontrib>YADAV, JAY</creatorcontrib><creatorcontrib>JOYE, JAMES</creatorcontrib><creatorcontrib>MYLA, SUBBARAO</creatorcontrib><creatorcontrib>KASSAB, ELIAS</creatorcontrib><creatorcontrib>MANN, J. TIFT</creatorcontrib><creatorcontrib>ANSEL, GARY M.</creatorcontrib><creatorcontrib>CREATE SpideRX Trial Investigators</creatorcontrib><creatorcontrib>on behalf of the CREATE SpideRX Trial Investigators</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of interventional cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>SAFIAN, ROBERT D.</au><au>JAFF, MICHAEL R.</au><au>BRESNAHAN, JOHN F.</au><au>FOSTER, MALCOLM</au><au>BACHARACH, J. MICHAEL</au><au>YADAV, JAY</au><au>JOYE, JAMES</au><au>MYLA, SUBBARAO</au><au>KASSAB, ELIAS</au><au>MANN, J. TIFT</au><au>ANSEL, GARY M.</au><aucorp>CREATE SpideRX Trial Investigators</aucorp><aucorp>on behalf of the CREATE SpideRX Trial Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial</atitle><jtitle>Journal of interventional cardiology</jtitle><addtitle>J Interv Cardiol</addtitle><date>2010-10</date><risdate>2010</risdate><volume>23</volume><issue>5</issue><spage>491</spage><epage>498</epage><pages>491-498</pages><issn>0896-4327</issn><eissn>1540-8183</eissn><abstract>Purpose:
A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high‐risk features for carotid endarterectomy was conducted during the 3‐month period from March to May 2005.
Methods:
Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration.
Results:
The primary end‐point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end‐point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05).
Conclusion:
CAS with distal embolic protection using the SpideRX™ Embolic Protection System is a reasonable alternative for revascularization of some high‐risk patients with severe carotid stenosis. (J Interven Cardiol 2010;23:491–498)</abstract><cop>Malden, USA</cop><pub>Blackwell Publishing Inc</pub><pmid>20624206</pmid><doi>10.1111/j.1540-8183.2010.00578.x</doi><tpages>8</tpages></addata></record> |
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| identifier | ISSN: 0896-4327 |
| ispartof | Journal of interventional cardiology, 2010-10, Vol.23 (5), p.491-498 |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Aged Aged, 80 and over Angioplasty, Balloon, Coronary - methods Carotid Arteries - pathology Carotid Stenosis - pathology Carotid Stenosis - prevention & control Carotid Stenosis - therapy Confidence Intervals Feasibility Studies Female Humans Logistic Models Male Middle Aged Multivariate Analysis Odds Ratio Prospective Studies Registries Risk Factors Stents |
| title | Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial |
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