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
Hauptverfasser: STRAUSS, Bradley H, OSHEROV, Azriel B, RADHAKRISHNAN, Sam, JOHN MANCINI, G. B, MANNERS, Allison, SPARKES, John D, CHISHOLM, Robert J
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container_end_page 528
container_issue 3
container_start_page 522
container_title Circulation (New York, N.Y.)
container_volume 125
creator STRAUSS, Bradley H
OSHEROV, Azriel B
RADHAKRISHNAN, Sam
JOHN MANCINI, G. B
MANNERS, Allison
SPARKES, John D
CHISHOLM, Robert J
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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B ; MANNERS, Allison ; SPARKES, John D ; CHISHOLM, Robert J</creator><creatorcontrib>STRAUSS, Bradley H ; OSHEROV, Azriel B ; RADHAKRISHNAN, Sam ; JOHN MANCINI, G. B ; MANNERS, Allison ; SPARKES, John D ; CHISHOLM, Robert J</creatorcontrib><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&lt;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. 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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. 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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&lt;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 &amp; 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 &amp; 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. 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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&lt;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 &amp; 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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