Total Occlusion Study in Coronary Arteries - 5
- Conditions
- Chronic Coronary Total Occlusions
- Interventions
- Biological: collagenaseDrug: saline
- Registration Number
- NCT01753180
- Lead Sponsor
- Matrizyme Pharma Corporation
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Male or females patients > 18 years of age who has a clinically driven, planned PCI of the target CTO, in a major epicardial coronary artery, without planned revascularization of other coronary stenosis/stenoses in major epicardial segments.
- 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)
- Documented chest radiation exposure > 4.0 Gray within 8 weeks of Day 0
- 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
- Angiographic exclusion criteria as defined in the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description collagenase collagenase - saline saline -
- Primary Outcome Measures
Name Time Method Anterograde PCI success rate for patients with a target CTO Day 1 of study procedures To assess the PCI success rates in CTOs that have failed a previous PCI attempt between different doses of MZ-004 and placebo
- Secondary Outcome Measures
Name Time Method Total fluoroscopy time Day 0 and Day 1 of study procedures To assess the total fluoroscopy time between patients treated with two different doses of MZ-004 and/or placebo
Total PCI procedural time Day 1 of study procedures To assess the total procedural time between patients treated with two different doses of MZ-004 and/or placebo
Soft wire crossing Day 1 study procedures To assess the percentage of lesions that are crossed with soft guide wires post study drug administration
Safety Day 0, Day 1 and Day 2 of study procedures 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
Trial Locations
- Locations (13)
Academic Medical Center
🇳🇱Amsterdam, Netherlands
CHUM Hotel Dieu
🇨🇦Montreal, Quebec, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec
🇨🇦Ste. Foy, Quebec, Canada