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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Local intra-coronary administration of MZ-004 at or into the CTO
Local intra-coronary administration of saline at or into the CTO
Foothills Medical Centre
Calgary, Alberta, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
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
Time frame: Day 1 of study procedures
Total fluoroscopy time
To assess the total fluoroscopy time between patients treated with two different doses of MZ-004 and/or placebo
Time frame: Day 0 and Day 1 of study procedures
Total PCI procedural time
To assess the total procedural time between patients treated with two different doses of MZ-004 and/or placebo
Time frame: 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
Time frame: 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
Time frame: Day 0, Day 1 and Day 2 of study procedures
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 3 more locations