Total Occlusion Study in Coronary Arteries - 5

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Coronary Total Occlusions

Intervention / Treatment
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* Biological: collagenase
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: collagenase<br> | Biological: collagenase<br>* Local intra-coronary administration of MZ-004 at or into the CTO<br>* Other names: MZ-004;|
| Placebo Comparator: saline<br> | Drug: saline<br>* Local intra-coronary administration of saline at or into the CTO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTO, PCI, Angioplasty