Total Occlusion Study in Coronary Arteries - 5 (TOSCA-5)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Coronary Total Occlusions
• Intervention / Treatment: Biological: collagenase; Drug: saline

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Foothills Medical Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Coeur de Montreal
    • Montreal, Quebec, Canada, H2W 1T8
      • CHUM Hôtel Dieu
    • Ste. Foy, Quebec, Canada, G1V 4G5
      • Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec
• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: collagenase	Biological: collagenase; Local intra-coronary administration of MZ-004 at or into the CTO; Other Names: MZ-004
PLACEBO_COMPARATOR: saline	Drug: saline; Local intra-coronary administration of saline at or into the CTO

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Matrizyme Pharma Corporation
• Investigators: Principal Investigator: Christopher Buller, Dr., St. Michael's Hospital, Toronto, Ontario, Canada

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (ESTIMATE): December 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: PCI; Angioplasty; CTO
• Other Study ID Numbers: CTO-201