Collagenase Total Occlusion-1 (CTO-1) Trial: A Phase I, Dose-Escalation, Safety Study
Percutaneous interventions for chronic total occlusions have low success rates, primarily because of failure of guide wire crossing. Collagen-rich matrix constitutes the main barrier to chronic total occlusion crossing. In preclinical studies, local delivery of a bacterial collagenase formulation im...
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Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2012-01, Vol.125 (3), p.522-528 |
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description | Percutaneous interventions for chronic total occlusions have low success rates, primarily because of failure of guide wire crossing. Collagen-rich matrix constitutes the main barrier to chronic total occlusion crossing. In preclinical studies, local delivery of a bacterial collagenase formulation improved guide wire crossing. The Collagenase Total Occlusion-1 (CTO-1) Trial is a phase I, dose-escalation trial to assess the safety and efficacy of collagenase therapy to facilitate guide wire crossing in coronary artery chronic occlusions.
Twenty subjects with ≥1 previous failure of chronic total occlusion guide wire crossing were enrolled at 2 sites. Subjects were treated in 4 distinct cohorts of 5 patients, with escalation of collagenase dose in each cohort from 300 to 1200 μg. Collagenase was locally delivered into the occlusions with either an over-the-wire balloon system (n=8) or a fine-cross microcatheter (n=12) for a period of 30 minutes. Subjects were brought back to the catheterization laboratory for guide wire crossing and angioplasty the next day. Guide wire crossing was successfully achieved in 15 subjects (75%). A soft-tip guide wire (Whisper, Pilot-50, Fielder XT) was either the sole or predominant guide wire used in 75% of successful crossings. Non-ST-segment-elevation myocardial infarctions occurred in 3 patients as a result of side-branch ischemia during stenting. Computed tomographic angiography at 3 months showed no late complications and patent stents in successfully treated chronic total occlusion. Anginal improvement occurred with a reduction in Canadian Cardiovascular Society class from baseline to 3 months (2.5±0.6 versus 0.9±0.9; P |
doi_str_mv | 10.1161/CIRCULATIONAHA.111.063198 |
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Twenty subjects with ≥1 previous failure of chronic total occlusion guide wire crossing were enrolled at 2 sites. Subjects were treated in 4 distinct cohorts of 5 patients, with escalation of collagenase dose in each cohort from 300 to 1200 μg. Collagenase was locally delivered into the occlusions with either an over-the-wire balloon system (n=8) or a fine-cross microcatheter (n=12) for a period of 30 minutes. Subjects were brought back to the catheterization laboratory for guide wire crossing and angioplasty the next day. Guide wire crossing was successfully achieved in 15 subjects (75%). A soft-tip guide wire (Whisper, Pilot-50, Fielder XT) was either the sole or predominant guide wire used in 75% of successful crossings. Non-ST-segment-elevation myocardial infarctions occurred in 3 patients as a result of side-branch ischemia during stenting. Computed tomographic angiography at 3 months showed no late complications and patent stents in successfully treated chronic total occlusion. Anginal improvement occurred with a reduction in Canadian Cardiovascular Society class from baseline to 3 months (2.5±0.6 versus 0.9±0.9; P<0.001).
Local delivery of collagenase into coronary chronic total occlusion is feasible and safe with encouraging guide wire crossing results in previously failed cases. Larger clinical trials are required to determine efficacy.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01271335.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/CIRCULATIONAHA.111.063198</identifier><identifier>PMID: 22179536</identifier><identifier>CODEN: CIRCAZ</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Adult ; Aged ; Angioplasty, Balloon, Coronary - methods ; Bacterial Proteins - administration & dosage ; Bacterial Proteins - adverse effects ; Biological and medical sciences ; Blood and lymphatic vessels ; Cardiology. Vascular system ; Cardiovascular system ; Chronic Disease ; Collagenases - administration & dosage ; Collagenases - adverse effects ; Combined Modality Therapy ; Coronary Angiography ; Coronary Occlusion - diagnostic imaging ; Coronary Occlusion - drug therapy ; Coronary Occlusion - therapy ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Dose-Response Relationship, Drug ; Feasibility Studies ; Humans ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Prospective Studies ; Treatment Outcome ; Vasodilator agents. Cerebral vasodilators</subject><ispartof>Circulation (New York, N.Y.), 2012-01, Vol.125 (3), p.522-528</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c415t-248771cfe05361ee0270aa90ec3ac6cd34a48bf9285caa762b3b91548eff73e23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,3685,27922,27923</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25518530$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22179536$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>STRAUSS, Bradley H</creatorcontrib><creatorcontrib>OSHEROV, Azriel B</creatorcontrib><creatorcontrib>RADHAKRISHNAN, Sam</creatorcontrib><creatorcontrib>JOHN MANCINI, G. B</creatorcontrib><creatorcontrib>MANNERS, Allison</creatorcontrib><creatorcontrib>SPARKES, John D</creatorcontrib><creatorcontrib>CHISHOLM, Robert J</creatorcontrib><title>Collagenase Total Occlusion-1 (CTO-1) Trial: A Phase I, Dose-Escalation, Safety Study</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>Percutaneous interventions for chronic total occlusions have low success rates, primarily because of failure of guide wire crossing. Collagen-rich matrix constitutes the main barrier to chronic total occlusion crossing. In preclinical studies, local delivery of a bacterial collagenase formulation improved guide wire crossing. The Collagenase Total Occlusion-1 (CTO-1) Trial is a phase I, dose-escalation trial to assess the safety and efficacy of collagenase therapy to facilitate guide wire crossing in coronary artery chronic occlusions.
Twenty subjects with ≥1 previous failure of chronic total occlusion guide wire crossing were enrolled at 2 sites. Subjects were treated in 4 distinct cohorts of 5 patients, with escalation of collagenase dose in each cohort from 300 to 1200 μg. Collagenase was locally delivered into the occlusions with either an over-the-wire balloon system (n=8) or a fine-cross microcatheter (n=12) for a period of 30 minutes. Subjects were brought back to the catheterization laboratory for guide wire crossing and angioplasty the next day. Guide wire crossing was successfully achieved in 15 subjects (75%). A soft-tip guide wire (Whisper, Pilot-50, Fielder XT) was either the sole or predominant guide wire used in 75% of successful crossings. Non-ST-segment-elevation myocardial infarctions occurred in 3 patients as a result of side-branch ischemia during stenting. Computed tomographic angiography at 3 months showed no late complications and patent stents in successfully treated chronic total occlusion. Anginal improvement occurred with a reduction in Canadian Cardiovascular Society class from baseline to 3 months (2.5±0.6 versus 0.9±0.9; P<0.001).
Local delivery of collagenase into coronary chronic total occlusion is feasible and safe with encouraging guide wire crossing results in previously failed cases. Larger clinical trials are required to determine efficacy.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01271335.</description><subject>Adult</subject><subject>Aged</subject><subject>Angioplasty, Balloon, Coronary - methods</subject><subject>Bacterial Proteins - administration & dosage</subject><subject>Bacterial Proteins - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular system</subject><subject>Chronic Disease</subject><subject>Collagenases - administration & dosage</subject><subject>Collagenases - adverse effects</subject><subject>Combined Modality Therapy</subject><subject>Coronary Angiography</subject><subject>Coronary Occlusion - diagnostic imaging</subject><subject>Coronary Occlusion - drug therapy</subject><subject>Coronary Occlusion - therapy</subject><subject>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</subject><subject>Dose-Response Relationship, Drug</subject><subject>Feasibility Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><subject>Vasodilator agents. Cerebral vasodilators</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkNFOwjAUhhujEURfwdQLE00Y9rTrtnphskwUEiJGxvVyKB3MzI2sw4S3dwREuWp6-v3_aT5CboD1ADx4iIYf0XQUxsPxWzgImxn0mCdABSekDZK7jiuFOiVtxphyfMF5i1xY-9lcPeHLc9LiHHwlhdcm06jMc1yYAq2hcVljTsda52ublYUD9C6Kxw7c07jKMH-kIX1fbsFhlz6X1jh9qzHHumG7dIKpqTd0Uq_nm0tylmJuzdX-7JDpSz-OBs5o_DqMwpGjXZC1w93A90GnhjV_AWMY9xmiYkYL1J6eCxfdYJYqHkiN6Ht8JmYKpBuYNPWF4aJDnna9q_Xsy8y1KeoK82RVZV9YbZISs-T4pciWyaL8ToSS4AZBU6B2Bboqra1MesgCS7auk2PXzQySnesme_1_-SH5K7cBbvcAbj2lFRY6s3-clBBIwcQPy2KIUg</recordid><startdate>20120124</startdate><enddate>20120124</enddate><creator>STRAUSS, Bradley H</creator><creator>OSHEROV, Azriel B</creator><creator>RADHAKRISHNAN, Sam</creator><creator>JOHN MANCINI, G. B</creator><creator>MANNERS, Allison</creator><creator>SPARKES, John D</creator><creator>CHISHOLM, Robert J</creator><general>Lippincott Williams & Wilkins</general><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>5PM</scope></search><sort><creationdate>20120124</creationdate><title>Collagenase Total Occlusion-1 (CTO-1) Trial: A Phase I, Dose-Escalation, Safety Study</title><author>STRAUSS, Bradley H ; OSHEROV, Azriel B ; RADHAKRISHNAN, Sam ; JOHN MANCINI, G. B ; MANNERS, Allison ; SPARKES, John D ; CHISHOLM, Robert J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-248771cfe05361ee0270aa90ec3ac6cd34a48bf9285caa762b3b91548eff73e23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Angioplasty, Balloon, Coronary - methods</topic><topic>Bacterial Proteins - administration & dosage</topic><topic>Bacterial Proteins - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular system</topic><topic>Chronic Disease</topic><topic>Collagenases - administration & dosage</topic><topic>Collagenases - adverse effects</topic><topic>Combined Modality Therapy</topic><topic>Coronary Angiography</topic><topic>Coronary Occlusion - diagnostic imaging</topic><topic>Coronary Occlusion - drug therapy</topic><topic>Coronary Occlusion - therapy</topic><topic>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</topic><topic>Dose-Response Relationship, Drug</topic><topic>Feasibility Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Treatment Outcome</topic><topic>Vasodilator agents. Cerebral vasodilators</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>STRAUSS, Bradley H</creatorcontrib><creatorcontrib>OSHEROV, Azriel B</creatorcontrib><creatorcontrib>RADHAKRISHNAN, Sam</creatorcontrib><creatorcontrib>JOHN MANCINI, G. B</creatorcontrib><creatorcontrib>MANNERS, Allison</creatorcontrib><creatorcontrib>SPARKES, John D</creatorcontrib><creatorcontrib>CHISHOLM, Robert J</creatorcontrib><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>PubMed Central (Full Participant titles)</collection><jtitle>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>STRAUSS, Bradley H</au><au>OSHEROV, Azriel B</au><au>RADHAKRISHNAN, Sam</au><au>JOHN MANCINI, G. B</au><au>MANNERS, Allison</au><au>SPARKES, John D</au><au>CHISHOLM, Robert J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Collagenase Total Occlusion-1 (CTO-1) Trial: A Phase I, Dose-Escalation, Safety Study</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2012-01-24</date><risdate>2012</risdate><volume>125</volume><issue>3</issue><spage>522</spage><epage>528</epage><pages>522-528</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><coden>CIRCAZ</coden><abstract>Percutaneous interventions for chronic total occlusions have low success rates, primarily because of failure of guide wire crossing. Collagen-rich matrix constitutes the main barrier to chronic total occlusion crossing. In preclinical studies, local delivery of a bacterial collagenase formulation improved guide wire crossing. The Collagenase Total Occlusion-1 (CTO-1) Trial is a phase I, dose-escalation trial to assess the safety and efficacy of collagenase therapy to facilitate guide wire crossing in coronary artery chronic occlusions.
Twenty subjects with ≥1 previous failure of chronic total occlusion guide wire crossing were enrolled at 2 sites. Subjects were treated in 4 distinct cohorts of 5 patients, with escalation of collagenase dose in each cohort from 300 to 1200 μg. Collagenase was locally delivered into the occlusions with either an over-the-wire balloon system (n=8) or a fine-cross microcatheter (n=12) for a period of 30 minutes. Subjects were brought back to the catheterization laboratory for guide wire crossing and angioplasty the next day. Guide wire crossing was successfully achieved in 15 subjects (75%). A soft-tip guide wire (Whisper, Pilot-50, Fielder XT) was either the sole or predominant guide wire used in 75% of successful crossings. Non-ST-segment-elevation myocardial infarctions occurred in 3 patients as a result of side-branch ischemia during stenting. Computed tomographic angiography at 3 months showed no late complications and patent stents in successfully treated chronic total occlusion. Anginal improvement occurred with a reduction in Canadian Cardiovascular Society class from baseline to 3 months (2.5±0.6 versus 0.9±0.9; P<0.001).
Local delivery of collagenase into coronary chronic total occlusion is feasible and safe with encouraging guide wire crossing results in previously failed cases. Larger clinical trials are required to determine efficacy.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01271335.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>22179536</pmid><doi>10.1161/CIRCULATIONAHA.111.063198</doi><tpages>7</tpages></addata></record> |
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source | MEDLINE; American Heart Association Journals; Journals@Ovid Complete; EZB-FREE-00999 freely available EZB journals |
subjects | Adult Aged Angioplasty, Balloon, Coronary - methods Bacterial Proteins - administration & dosage Bacterial Proteins - adverse effects Biological and medical sciences Blood and lymphatic vessels Cardiology. Vascular system Cardiovascular system Chronic Disease Collagenases - administration & dosage Collagenases - adverse effects Combined Modality Therapy Coronary Angiography Coronary Occlusion - diagnostic imaging Coronary Occlusion - drug therapy Coronary Occlusion - therapy Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Dose-Response Relationship, Drug Feasibility Studies Humans Male Medical sciences Middle Aged Pharmacology. Drug treatments Prospective Studies Treatment Outcome Vasodilator agents. Cerebral vasodilators |
title | Collagenase Total Occlusion-1 (CTO-1) Trial: A Phase I, Dose-Escalation, Safety Study |
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