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A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study, evaluating acute intra-coronary injected collagenase prior to routine standard-of-care percutaneous revascularization procedures in subjects with chronic total coronary artery occlusions (CTOs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| collagenase | Experimental |
| |
| saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagenase | Biological | Local intra-coronary administration of MZ-004 at or into the CTO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterograde PCI success rate for patients with a target CTO | To assess the PCI success rates in CTOs that have failed a previous PCI attempt between different doses of MZ-004 and placebo | Day 1 of study procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Total fluoroscopy time | To assess the total fluoroscopy time between patients treated with two different doses of MZ-004 and/or placebo | Day 0 and Day 1 of study procedures |
| Total PCI procedural time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Buller, Dr. | St. Michael's Hospital, Toronto, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 4Z6 | Canada | ||
| St. Boniface Hospital |
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| ID | Term |
|---|---|
| D017364 | Collagenases |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| saline | Drug | Local intra-coronary administration of saline at or into the CTO |
|
To assess the total procedural time between patients treated with two different doses of MZ-004 and/or placebo
| Day 1 of study procedures |
| Soft wire crossing | To assess the percentage of lesions that are crossed with soft guide wires post study drug administration | Day 1 study procedures |
| Safety | To assess the overall safety of the procedure in evaluating treatment emergent adverse events, major adverse cardiac events, radiation exposure, angiographic complications, ECGs, vital signs and clinical laboratory parameters | Day 0, Day 1 and Day 2 of study procedures |
| Winnipeg |
| Manitoba |
| R2H 2A6 |
| Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| CHUM Hotel Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec | Ste. Foy | Quebec | G1V 4G5 | Canada |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |