Chronic Coronary Total Occlusions
Conditions
Keywords
CTO, PCI, Angioplasty
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).
Interventions
BIOLOGICALcollagenase
Local intra-coronary administration of MZ-004 at or into the CTO
DRUGsaline
Local intra-coronary administration of saline at or into the CTO
Sponsors
Matrizyme Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, Israel, Netherlands
Outcome results
None listed