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

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ClinicalTrials.gov Identifier: NCT01753180
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Matrizyme Pharma Corporation

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).

Condition or disease Intervention/treatment Phase
Chronic Coronary Total Occlusions Biological: collagenase Drug: saline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
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
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753180


Locations
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
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Matrizyme Pharma Corporation
Investigators
Principal Investigator: Christopher Buller, Dr. St. Michael's Hospital, Toronto, Ontario, Canada

Responsible Party: Matrizyme Pharma Corporation
ClinicalTrials.gov Identifier: NCT01753180     History of Changes
Other Study ID Numbers: CTO-201
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by Matrizyme Pharma Corporation:
CTO
PCI
Angioplasty