Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: Results from the multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study
Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in thromboembolic complications, including no‐reflow, distal branch occlusion, periprocedural MI, and death. The utility of a novel thromboatherectomy device, the X‐Sizer, was tested in 50 consecutive patients a...
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| Veröffentlicht in: | Catheterization and cardiovascular interventions 2003-04, Vol.58 (4), p.419-427 |
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| container_title | Catheterization and cardiovascular interventions |
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| creator | Stone, Gregg W. Cox, David A. Low, Reginald Cates, Christopher U. Satler, Lowell Bailey, Steven R. Kuntz, Richard E. Lansky, Alexandra J. |
| description | Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in thromboembolic complications, including no‐reflow, distal branch occlusion, periprocedural MI, and death. The utility of a novel thromboatherectomy device, the X‐Sizer, was tested in 50 consecutive patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native coronary arteries; thrombus was present in 78% of lesions, and TIMI 0–1 flow in 21%. TIMI 3 flow improved from 57% at baseline to 94% postprocedure. No patient developed visible distal thromboemboli, side‐branch occlusion, or reduced antegrade flow. Thirty‐day events included one death (2.0%), Q‐ or non–Q‐wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that the use of the X‐Sizer prior to percutaneous intervention is safe in high‐risk vein grafts and thrombotic lesions and results in a low rate of adverse events compared to historical controls. Cathet Cardiovasc Intervent 2003;58:419–427. © 2003 Wiley‐Liss, Inc. |
| doi_str_mv | 10.1002/ccd.10511 |
| format | Article |
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The utility of a novel thromboatherectomy device, the X‐Sizer, was tested in 50 consecutive patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native coronary arteries; thrombus was present in 78% of lesions, and TIMI 0–1 flow in 21%. TIMI 3 flow improved from 57% at baseline to 94% postprocedure. No patient developed visible distal thromboemboli, side‐branch occlusion, or reduced antegrade flow. Thirty‐day events included one death (2.0%), Q‐ or non–Q‐wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that the use of the X‐Sizer prior to percutaneous intervention is safe in high‐risk vein grafts and thrombotic lesions and results in a low rate of adverse events compared to historical controls. Cathet Cardiovasc Intervent 2003;58:419–427. © 2003 Wiley‐Liss, Inc.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.10511</identifier><identifier>PMID: 12652487</identifier><language>eng</language><publisher>New York: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Aged ; Angioplasty, Balloon, Coronary - instrumentation ; Angioplasty, Balloon, Coronary - methods ; Atherectomy, Coronary - methods ; Biological and medical sciences ; Cardiology. Vascular system ; Chi-Square Distribution ; Coronary Angiography ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - therapy ; Coronary heart disease ; Coronary Thrombosis - diagnostic imaging ; Coronary Thrombosis - therapy ; Equipment Design ; Equipment Safety ; Female ; Follow-Up Studies ; Graft Occlusion, Vascular - diagnostic imaging ; Graft Occlusion, Vascular - therapy ; Heart ; Humans ; Male ; Medical sciences ; Middle Aged ; Probability ; Risk Assessment ; Saphenous Vein - pathology ; Saphenous Vein - transplantation ; saphenous vein graft ; Statistics, Nonparametric ; stent ; Stents ; thrombectomy ; Thrombectomy - methods ; thrombus ; Treatment Outcome</subject><ispartof>Catheterization and cardiovascular interventions, 2003-04, Vol.58 (4), p.419-427</ispartof><rights>Copyright © 2003 Wiley‐Liss, Inc.</rights><rights>2003 INIST-CNRS</rights><rights>Copyright 2003 Wiley-Liss, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3911-efd861cee3bdb07476f15e31c8bdd62917a45a91bdda68aebc95b08d25ae73d33</citedby><cites>FETCH-LOGICAL-c3911-efd861cee3bdb07476f15e31c8bdd62917a45a91bdda68aebc95b08d25ae73d33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fccd.10511$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.10511$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14662149$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12652487$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stone, Gregg W.</creatorcontrib><creatorcontrib>Cox, David A.</creatorcontrib><creatorcontrib>Low, Reginald</creatorcontrib><creatorcontrib>Cates, Christopher U.</creatorcontrib><creatorcontrib>Satler, Lowell</creatorcontrib><creatorcontrib>Bailey, Steven R.</creatorcontrib><creatorcontrib>Kuntz, Richard E.</creatorcontrib><creatorcontrib>Lansky, Alexandra J.</creatorcontrib><creatorcontrib>X-TRACT Investigators</creatorcontrib><title>Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: Results from the multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study</title><title>Catheterization and cardiovascular interventions</title><addtitle>Cathet. Cardiovasc. Intervent</addtitle><description>Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in thromboembolic complications, including no‐reflow, distal branch occlusion, periprocedural MI, and death. The utility of a novel thromboatherectomy device, the X‐Sizer, was tested in 50 consecutive patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native coronary arteries; thrombus was present in 78% of lesions, and TIMI 0–1 flow in 21%. TIMI 3 flow improved from 57% at baseline to 94% postprocedure. No patient developed visible distal thromboemboli, side‐branch occlusion, or reduced antegrade flow. Thirty‐day events included one death (2.0%), Q‐ or non–Q‐wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that the use of the X‐Sizer prior to percutaneous intervention is safe in high‐risk vein grafts and thrombotic lesions and results in a low rate of adverse events compared to historical controls. Cathet Cardiovasc Intervent 2003;58:419–427. © 2003 Wiley‐Liss, Inc.</description><subject>Aged</subject><subject>Angioplasty, Balloon, Coronary - instrumentation</subject><subject>Angioplasty, Balloon, Coronary - methods</subject><subject>Atherectomy, Coronary - methods</subject><subject>Biological and medical sciences</subject><subject>Cardiology. Vascular system</subject><subject>Chi-Square Distribution</subject><subject>Coronary Angiography</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - therapy</subject><subject>Coronary heart disease</subject><subject>Coronary Thrombosis - diagnostic imaging</subject><subject>Coronary Thrombosis - therapy</subject><subject>Equipment Design</subject><subject>Equipment Safety</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Graft Occlusion, Vascular - diagnostic imaging</subject><subject>Graft Occlusion, Vascular - therapy</subject><subject>Heart</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Probability</subject><subject>Risk Assessment</subject><subject>Saphenous Vein - pathology</subject><subject>Saphenous Vein - transplantation</subject><subject>saphenous vein graft</subject><subject>Statistics, Nonparametric</subject><subject>stent</subject><subject>Stents</subject><subject>thrombectomy</subject><subject>Thrombectomy - methods</subject><subject>thrombus</subject><subject>Treatment Outcome</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kktv1DAUhQMC0VJYsGGJvKGii9DYebOrptAiVYCGQZ2d5djXjCGxB19nYPj1eB4wC9RN_PqOz7nOTZJnNHtNs4ydS6nipKT0fnJMS8bSmlXzB_s5bYvqKHmM-C3LsrZi7aPkiLKqZEVTH997_lloCGsirCKgtZFCronTRBDrVtATBSsjgWjnSfAgwgA2bM7Dwruhc8HIrVSEBXiHso_fzV4PaJxFYiyxIpgVEOm8s8JHJx_AG8CtDsVyAdaNSFYQ2a9e6IBvyBRw7AMSHU2iFZAhLmMOG6VknqL5Hcc7Mo34XyI02ySHCMtlHysN24jBG9GTV_N0Nr2YzM4IhlGtnyQPtegRnu7Hk-TLu7ezyXV68_Hq_eTiJpV5S2kKWjUVlQB5p7qsLupK0xJyKptOqfjUtBZFKVoaV6JqBHSyLbusUawUUOcqz0-S0929S-9-jICBDwYl9L2wEF-F1zllJc1ZBM92oIzloAfNl94MsRhOM75pAh6bgG-bILIv9peO3QDqQO7_egRe7gGBUvTaCysNHriiqhgt2sid77ifpof13Y58Mrn8a53uFAYD_PqnEP47r-q8LvnthytefLpupqy8jdX9AXHx33g</recordid><startdate>200304</startdate><enddate>200304</enddate><creator>Stone, Gregg W.</creator><creator>Cox, David A.</creator><creator>Low, Reginald</creator><creator>Cates, Christopher U.</creator><creator>Satler, Lowell</creator><creator>Bailey, Steven R.</creator><creator>Kuntz, Richard E.</creator><creator>Lansky, Alexandra J.</creator><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley-Liss</general><scope>BSCLL</scope><scope>IQODW</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>200304</creationdate><title>Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: Results from the multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study</title><author>Stone, Gregg W. ; Cox, David A. ; Low, Reginald ; Cates, Christopher U. ; Satler, Lowell ; Bailey, Steven R. ; Kuntz, Richard E. ; Lansky, Alexandra J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3911-efd861cee3bdb07476f15e31c8bdd62917a45a91bdda68aebc95b08d25ae73d33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Aged</topic><topic>Angioplasty, Balloon, Coronary - instrumentation</topic><topic>Angioplasty, Balloon, Coronary - methods</topic><topic>Atherectomy, Coronary - methods</topic><topic>Biological and medical sciences</topic><topic>Cardiology. Vascular system</topic><topic>Chi-Square Distribution</topic><topic>Coronary Angiography</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - therapy</topic><topic>Coronary heart disease</topic><topic>Coronary Thrombosis - diagnostic imaging</topic><topic>Coronary Thrombosis - therapy</topic><topic>Equipment Design</topic><topic>Equipment Safety</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Graft Occlusion, Vascular - diagnostic imaging</topic><topic>Graft Occlusion, Vascular - therapy</topic><topic>Heart</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Probability</topic><topic>Risk Assessment</topic><topic>Saphenous Vein - pathology</topic><topic>Saphenous Vein - transplantation</topic><topic>saphenous vein graft</topic><topic>Statistics, Nonparametric</topic><topic>stent</topic><topic>Stents</topic><topic>thrombectomy</topic><topic>Thrombectomy - methods</topic><topic>thrombus</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stone, Gregg W.</creatorcontrib><creatorcontrib>Cox, David A.</creatorcontrib><creatorcontrib>Low, Reginald</creatorcontrib><creatorcontrib>Cates, Christopher U.</creatorcontrib><creatorcontrib>Satler, Lowell</creatorcontrib><creatorcontrib>Bailey, Steven R.</creatorcontrib><creatorcontrib>Kuntz, Richard E.</creatorcontrib><creatorcontrib>Lansky, Alexandra J.</creatorcontrib><creatorcontrib>X-TRACT Investigators</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</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>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stone, Gregg W.</au><au>Cox, David A.</au><au>Low, Reginald</au><au>Cates, Christopher U.</au><au>Satler, Lowell</au><au>Bailey, Steven R.</au><au>Kuntz, Richard E.</au><au>Lansky, Alexandra J.</au><aucorp>X-TRACT Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: Results from the multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Cathet. Cardiovasc. Intervent</addtitle><date>2003-04</date><risdate>2003</risdate><volume>58</volume><issue>4</issue><spage>419</spage><epage>427</epage><pages>419-427</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in thromboembolic complications, including no‐reflow, distal branch occlusion, periprocedural MI, and death. The utility of a novel thromboatherectomy device, the X‐Sizer, was tested in 50 consecutive patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native coronary arteries; thrombus was present in 78% of lesions, and TIMI 0–1 flow in 21%. TIMI 3 flow improved from 57% at baseline to 94% postprocedure. No patient developed visible distal thromboemboli, side‐branch occlusion, or reduced antegrade flow. Thirty‐day events included one death (2.0%), Q‐ or non–Q‐wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that the use of the X‐Sizer prior to percutaneous intervention is safe in high‐risk vein grafts and thrombotic lesions and results in a low rate of adverse events compared to historical controls. Cathet Cardiovasc Intervent 2003;58:419–427. © 2003 Wiley‐Liss, Inc.</abstract><cop>New York</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>12652487</pmid><doi>10.1002/ccd.10511</doi><tpages>9</tpages></addata></record> |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Aged Angioplasty, Balloon, Coronary - instrumentation Angioplasty, Balloon, Coronary - methods Atherectomy, Coronary - methods Biological and medical sciences Cardiology. Vascular system Chi-Square Distribution Coronary Angiography Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - therapy Coronary heart disease Coronary Thrombosis - diagnostic imaging Coronary Thrombosis - therapy Equipment Design Equipment Safety Female Follow-Up Studies Graft Occlusion, Vascular - diagnostic imaging Graft Occlusion, Vascular - therapy Heart Humans Male Medical sciences Middle Aged Probability Risk Assessment Saphenous Vein - pathology Saphenous Vein - transplantation saphenous vein graft Statistics, Nonparametric stent Stents thrombectomy Thrombectomy - methods thrombus Treatment Outcome |
| title | Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: Results from the multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study |
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