Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2014-04-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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collagenase
collagenase
Local intra-coronary administration of MZ-004 at or into the CTO
saline
saline
Local intra-coronary administration of saline at or into the CTO
Interventions
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collagenase
Local intra-coronary administration of MZ-004 at or into the CTO
saline
Local intra-coronary administration of saline at or into the CTO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Target CTO must be greater than or equal to 3 calendar months prior to Screening
* Target CTO must meet protocol defined criteria for entry
* Patient is receiving a course of optimal anti-ischemic medical therapy (at least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy)
Exclusion Criteria
* Target vessel is not an occluded stent, saphenous vein graft
* Patient had ACS \< 4 weeks from Screening, attributable to any coronary vessel
* Patient has non-healed dissection plane extending to a point adjacent to the coronary lumen distal to the target CTO
* Patient has a known or suspected target vessel perforation within 30 days of Day 0
18 Years
100 Years
ALL
No
Sponsors
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Matrizyme Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Buller, Dr.
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital, Toronto, Ontario, Canada
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
CHUM Hotel Dieu
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec
Ste. Foy, Quebec, Canada
Shaare Zedek Medical Center
Jerusalem, , Israel
Academic Medical Center
Amsterdam, , Netherlands
Countries
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Other Identifiers
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CTO-201
Identifier Type: -
Identifier Source: org_study_id
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