Chronic Coronary Total Occlusions Clinical Trial
— TOSCA-5Official title:
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
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).
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | July 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 100 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Foothills Medical Centre | Calgary | Alberta |
| Canada | Hamilton Health Sciences | Hamilton | Ontario |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | CHUM Hotel Dieu | Montreal | Quebec |
| Canada | Hopital du Sacre-Coeur de Montreal | Montreal | Quebec |
| Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
| Canada | Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec | Ste. Foy | Quebec |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | Toronto General Hospital | Toronto | Ontario |
| Canada | St. Boniface Hospital | Winnipeg | Manitoba |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Netherlands | Academic Medical Center | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Matrizyme Pharma Corporation |
Canada, Israel, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | Soft wire crossing | To assess the percentage of lesions that are crossed with soft guide wires post study drug administration | Day 1 study procedures | No |
| Secondary | 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 | Yes |