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

This study has been completed.
Information provided by (Responsible Party):
Matrizyme Pharma Corporation Identifier:
First received: December 17, 2012
Last updated: July 7, 2016
Last verified: July 2016
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).

Condition Intervention Phase
Chronic Coronary Total Occlusions Biological: collagenase Drug: saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Further study details as provided by Matrizyme Pharma Corporation:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Total fluoroscopy time [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 study procedures ]
    To assess the percentage of lesions that are crossed with soft guide wires post study drug administration

  • Safety [ Time Frame: 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

Enrollment: 76
Study Start Date: April 2014
Study Completion Date: July 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: collagenase Biological: collagenase
Local intra-coronary administration of MZ-004 at or into the CTO
Other Name: MZ-004
Placebo Comparator: saline Drug: saline
Local intra-coronary administration of saline at or into the CTO


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01753180

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

Responsible Party: Matrizyme Pharma Corporation Identifier: NCT01753180     History of Changes
Other Study ID Numbers: CTO-201
Study First Received: December 17, 2012
Last Updated: July 7, 2016

Keywords provided by Matrizyme Pharma Corporation:
Angioplasty processed this record on September 19, 2017