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Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study
CENTRAL was a prospective, multicenter, 100 patient study designed to evaluate the ability of a recanalization catheter system to cross chronic total occlusions (CTOs) of the superficial femoral artery while staying within the central vessel lumen. The primary endpoint was the successful crossing of...
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| Published in: | The Journal of invasive cardiology 2016-11, Vol.28 (11), p.430-439 |
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| container_end_page | 439 |
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| container_title | The Journal of invasive cardiology |
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| creator | Torey, James Zaitoun, Anwar Lalonde, Thomas Runyon, John Mustapha, Jihad Davis, Thomas |
| description | CENTRAL was a prospective, multicenter, 100 patient study designed to evaluate the ability of a recanalization catheter system to cross chronic total occlusions (CTOs) of the superficial femoral artery while staying within the central vessel lumen.
The primary endpoint was the successful crossing of a CTO (≥90% of the length) with the recanalization catheter in the central lumen of the superficial femoral artery in at least one-half of the studied patient population, confirmed by intravascular ultrasound. Secondary endpoints included standardized anatomic damage assessment (the TAPE method) and an assessment of the relationship between the percent of CTO crossing and TAPE scores to the rate of target-lesion revascularization (TLR) at 30 days and 6 months.
The mean age of the occlusions was 16.6 ± 22.28 months (range, 1-120 months), the average occlusion length reported by the sites was 132.1 ± 87.69 mm (range, 4-300 mm), and a majority of lesions were moderately (42.0%) or severely (32.0%) calcified. In 43/85 (50.6%) of the evaluable intravascular ultrasound images, the recanalization catheter successfully navigated the central lumen of the CTO (ie, ≥90% luminal crossing) with >50% luminal crossing in 64/85 (75.3%) of cases. The 6-month TLR rate was significantly lower in patients where the CTO was crossed ≥90% in the central vessel lumen (4.7%) compared with crossings |
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The primary endpoint was the successful crossing of a CTO (≥90% of the length) with the recanalization catheter in the central lumen of the superficial femoral artery in at least one-half of the studied patient population, confirmed by intravascular ultrasound. Secondary endpoints included standardized anatomic damage assessment (the TAPE method) and an assessment of the relationship between the percent of CTO crossing and TAPE scores to the rate of target-lesion revascularization (TLR) at 30 days and 6 months.
The mean age of the occlusions was 16.6 ± 22.28 months (range, 1-120 months), the average occlusion length reported by the sites was 132.1 ± 87.69 mm (range, 4-300 mm), and a majority of lesions were moderately (42.0%) or severely (32.0%) calcified. In 43/85 (50.6%) of the evaluable intravascular ultrasound images, the recanalization catheter successfully navigated the central lumen of the CTO (ie, ≥90% luminal crossing) with >50% luminal crossing in 64/85 (75.3%) of cases. The 6-month TLR rate was significantly lower in patients where the CTO was crossed ≥90% in the central vessel lumen (4.7%) compared with crossings <90% (20.6%; P=.04). The 6-month TLR rate was 3.5% in patients with a favorable TAPE score of 0-4 and 36.8% with an unfavorable TAPE score of 5-8 (P<.001).
Use of a recanalization catheter in complex superficial femoral artery CTO crossings achieved intraluminal crossings in >50% of cases and decreased anatomic damage, which appeared to offer a significant advantage in 6-month TLR rates.</description><identifier>EISSN: 1557-2501</identifier><identifier>PMID: 27743508</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Arterial Occlusive Diseases - diagnosis ; Arterial Occlusive Diseases - etiology ; Arterial Occlusive Diseases - surgery ; Catheterization, Peripheral - instrumentation ; Catheterization, Peripheral - methods ; Female ; Femoral Artery - diagnostic imaging ; Femoral Artery - pathology ; Femoral Artery - surgery ; Humans ; Ischemia - diagnosis ; Ischemia - etiology ; Ischemia - surgery ; Lower Extremity - blood supply ; Male ; Middle Aged ; Outcome and Process Assessment (Health Care) ; Peripheral Vascular Diseases - complications ; Severity of Illness Index ; Ultrasonography, Interventional - methods ; Vascular Calcification</subject><ispartof>The Journal of invasive cardiology, 2016-11, Vol.28 (11), p.430-439</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27743508$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Torey, James</creatorcontrib><creatorcontrib>Zaitoun, Anwar</creatorcontrib><creatorcontrib>Lalonde, Thomas</creatorcontrib><creatorcontrib>Runyon, John</creatorcontrib><creatorcontrib>Mustapha, Jihad</creatorcontrib><creatorcontrib>Davis, Thomas</creatorcontrib><title>Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study</title><title>The Journal of invasive cardiology</title><addtitle>J Invasive Cardiol</addtitle><description>CENTRAL was a prospective, multicenter, 100 patient study designed to evaluate the ability of a recanalization catheter system to cross chronic total occlusions (CTOs) of the superficial femoral artery while staying within the central vessel lumen.
The primary endpoint was the successful crossing of a CTO (≥90% of the length) with the recanalization catheter in the central lumen of the superficial femoral artery in at least one-half of the studied patient population, confirmed by intravascular ultrasound. Secondary endpoints included standardized anatomic damage assessment (the TAPE method) and an assessment of the relationship between the percent of CTO crossing and TAPE scores to the rate of target-lesion revascularization (TLR) at 30 days and 6 months.
The mean age of the occlusions was 16.6 ± 22.28 months (range, 1-120 months), the average occlusion length reported by the sites was 132.1 ± 87.69 mm (range, 4-300 mm), and a majority of lesions were moderately (42.0%) or severely (32.0%) calcified. In 43/85 (50.6%) of the evaluable intravascular ultrasound images, the recanalization catheter successfully navigated the central lumen of the CTO (ie, ≥90% luminal crossing) with >50% luminal crossing in 64/85 (75.3%) of cases. The 6-month TLR rate was significantly lower in patients where the CTO was crossed ≥90% in the central vessel lumen (4.7%) compared with crossings <90% (20.6%; P=.04). The 6-month TLR rate was 3.5% in patients with a favorable TAPE score of 0-4 and 36.8% with an unfavorable TAPE score of 5-8 (P<.001).
Use of a recanalization catheter in complex superficial femoral artery CTO crossings achieved intraluminal crossings in >50% of cases and decreased anatomic damage, which appeared to offer a significant advantage in 6-month TLR rates.</description><subject>Aged</subject><subject>Arterial Occlusive Diseases - diagnosis</subject><subject>Arterial Occlusive Diseases - etiology</subject><subject>Arterial Occlusive Diseases - surgery</subject><subject>Catheterization, Peripheral - instrumentation</subject><subject>Catheterization, Peripheral - methods</subject><subject>Female</subject><subject>Femoral Artery - diagnostic imaging</subject><subject>Femoral Artery - pathology</subject><subject>Femoral Artery - surgery</subject><subject>Humans</subject><subject>Ischemia - diagnosis</subject><subject>Ischemia - etiology</subject><subject>Ischemia - surgery</subject><subject>Lower Extremity - blood supply</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Outcome and Process Assessment (Health Care)</subject><subject>Peripheral Vascular Diseases - complications</subject><subject>Severity of Illness Index</subject><subject>Ultrasonography, Interventional - methods</subject><subject>Vascular Calcification</subject><issn>1557-2501</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><recordid>eNo1UE1LAzEUDILYWv0LkqOXhXw0TdZbWaoWioW6PS8v2URX0mzdJEL99V2wwsC8gZnhMVdoSoWQBROETtBtjF-EMMpLeoMmTMo5F0RNkVkHN0AXPnIXwOOq3uKdNTDe3S-krg94GaMd0WJ9wuuQBviBaLKHAe_9qGKfQ_s0hmL2KeLe4fRpcbV6q3fLDX5PuT3doWsHPtr7C8_Q_nlVV6_FZvuyrpab4sgUTQUDIw2xGgzTSpTStly3gkhKFsSZ-fg6l9pxRag1yi2Y5qWkSoKQzgJVJZ-hx7_e49B_ZxtTc-iisd5DsH2ODVV8XpZCcjVaHy7WrA-2bY5Dd4Dh1PwPw88OaV5e</recordid><startdate>201611</startdate><enddate>201611</enddate><creator>Torey, James</creator><creator>Zaitoun, Anwar</creator><creator>Lalonde, Thomas</creator><creator>Runyon, John</creator><creator>Mustapha, Jihad</creator><creator>Davis, Thomas</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201611</creationdate><title>Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study</title><author>Torey, James ; Zaitoun, Anwar ; Lalonde, Thomas ; Runyon, John ; Mustapha, Jihad ; Davis, Thomas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p281t-2ac7c0ebac2b8597ed3bd5071060fc413937bf3801ec8f62b397187a57fea1893</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Arterial Occlusive Diseases - diagnosis</topic><topic>Arterial Occlusive Diseases - etiology</topic><topic>Arterial Occlusive Diseases - surgery</topic><topic>Catheterization, Peripheral - instrumentation</topic><topic>Catheterization, Peripheral - methods</topic><topic>Female</topic><topic>Femoral Artery - diagnostic imaging</topic><topic>Femoral Artery - pathology</topic><topic>Femoral Artery - surgery</topic><topic>Humans</topic><topic>Ischemia - diagnosis</topic><topic>Ischemia - etiology</topic><topic>Ischemia - surgery</topic><topic>Lower Extremity - blood supply</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Outcome and Process Assessment (Health Care)</topic><topic>Peripheral Vascular Diseases - complications</topic><topic>Severity of Illness Index</topic><topic>Ultrasonography, Interventional - methods</topic><topic>Vascular Calcification</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Torey, James</creatorcontrib><creatorcontrib>Zaitoun, Anwar</creatorcontrib><creatorcontrib>Lalonde, Thomas</creatorcontrib><creatorcontrib>Runyon, John</creatorcontrib><creatorcontrib>Mustapha, Jihad</creatorcontrib><creatorcontrib>Davis, Thomas</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of invasive cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Torey, James</au><au>Zaitoun, Anwar</au><au>Lalonde, Thomas</au><au>Runyon, John</au><au>Mustapha, Jihad</au><au>Davis, Thomas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study</atitle><jtitle>The Journal of invasive cardiology</jtitle><addtitle>J Invasive Cardiol</addtitle><date>2016-11</date><risdate>2016</risdate><volume>28</volume><issue>11</issue><spage>430</spage><epage>439</epage><pages>430-439</pages><eissn>1557-2501</eissn><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-1</notes><notes>content type line 23</notes><abstract>CENTRAL was a prospective, multicenter, 100 patient study designed to evaluate the ability of a recanalization catheter system to cross chronic total occlusions (CTOs) of the superficial femoral artery while staying within the central vessel lumen.
The primary endpoint was the successful crossing of a CTO (≥90% of the length) with the recanalization catheter in the central lumen of the superficial femoral artery in at least one-half of the studied patient population, confirmed by intravascular ultrasound. Secondary endpoints included standardized anatomic damage assessment (the TAPE method) and an assessment of the relationship between the percent of CTO crossing and TAPE scores to the rate of target-lesion revascularization (TLR) at 30 days and 6 months.
The mean age of the occlusions was 16.6 ± 22.28 months (range, 1-120 months), the average occlusion length reported by the sites was 132.1 ± 87.69 mm (range, 4-300 mm), and a majority of lesions were moderately (42.0%) or severely (32.0%) calcified. In 43/85 (50.6%) of the evaluable intravascular ultrasound images, the recanalization catheter successfully navigated the central lumen of the CTO (ie, ≥90% luminal crossing) with >50% luminal crossing in 64/85 (75.3%) of cases. The 6-month TLR rate was significantly lower in patients where the CTO was crossed ≥90% in the central vessel lumen (4.7%) compared with crossings <90% (20.6%; P=.04). The 6-month TLR rate was 3.5% in patients with a favorable TAPE score of 0-4 and 36.8% with an unfavorable TAPE score of 5-8 (P<.001).
Use of a recanalization catheter in complex superficial femoral artery CTO crossings achieved intraluminal crossings in >50% of cases and decreased anatomic damage, which appeared to offer a significant advantage in 6-month TLR rates.</abstract><cop>United States</cop><pmid>27743508</pmid><tpages>10</tpages></addata></record> |
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| ispartof | The Journal of invasive cardiology, 2016-11, Vol.28 (11), p.430-439 |
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| source | Freely Accessible Science Journals - check A-Z of ejournals |
| subjects | Aged Arterial Occlusive Diseases - diagnosis Arterial Occlusive Diseases - etiology Arterial Occlusive Diseases - surgery Catheterization, Peripheral - instrumentation Catheterization, Peripheral - methods Female Femoral Artery - diagnostic imaging Femoral Artery - pathology Femoral Artery - surgery Humans Ischemia - diagnosis Ischemia - etiology Ischemia - surgery Lower Extremity - blood supply Male Middle Aged Outcome and Process Assessment (Health Care) Peripheral Vascular Diseases - complications Severity of Illness Index Ultrasonography, Interventional - methods Vascular Calcification |
| title | Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study |
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