NCT01753180CompletedPhase 2
A 2-stage Study to Evaluate Single Doses of MZ-004 at Different Dose Levels in Patients With Chronic Total Occlusions. Stage 1: Open Label Training Stage. Stage 2: Double-blind, Randomized, Placebo-Controlled Stage
Matrizyme Pharma Corporation13 sites in 3 countries76 target enrollmentStarted: April 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 13
- Primary Endpoint
- Anterograde PCI success rate for patients with a target CTO
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 exclusion criteria as defined in the protocol
Arms & Interventions
collagenase
Experimental
Intervention: collagenase (Biological)
saline
Placebo Comparator
Intervention: saline (Drug)
Outcomes
Primary Outcomes
Anterograde PCI success rate for patients with a target CTO
Time Frame: 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 Outcomes
- Total fluoroscopy time(Day 0 and Day 1 of study procedures)
- Total PCI procedural time(Day 1 of study procedures)
- Soft wire crossing(Day 1 study procedures)
- Safety(Day 0, Day 1 and Day 2 of study procedures)
Investigators
Study Sites (13)
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