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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Matrizyme Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Matrizyme Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01753180
First received: December 17, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Primary Completion Date: September 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01753180

Contacts
Contact: Laura Agensky, MBA 1-905-771-0333 ext 100 laura.agensky@matrizyme.com
Contact: Allison Manners 1-905-771-0333 ext 102

Locations
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Sanjit Jolly, MD    1-905-527-4322 ext 40309      
Principal Investigator: Sanjit Jolly, MD         
Sub-Investigator: Nicholas Valletas, MD         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Patrick Teefy, MD    1-519-663-3728      
Principal Investigator: Patrick Teefy, MD         
University of Ottawa Heart Institute Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Alexander Dick, MX    1-613-761-5387      
Principal Investigator: Alexander Dick, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: John Graham, MD    1-416-864-6060 ext 5918      
Principal Investigator: John Graham, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Harindra Wijeysundera, MD    416-480-4527      
Principal Investigator: Harindra Wijeysundera, MD         
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Pooja Balakrishna    1-416-340-4800 ext 3354      
Canada, Quebec
CHUM Hotel Dieu Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Samer Mansour, MD    1-514-890-8100      
Principal Investigator: Samer Mansour, MD         
Hopital du Sacre-Coeur de Montreal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Erick Schampaert, MD    1-514-338-2340      
Principal Investigator: Erick Schampaert, MD         
Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec Recruiting
Ste. Foy, Quebec, Canada, G1V 4G5
Contact: Stephane Rinfret, MD    1-418-656-8711 ext 3289      
Principal Investigator: Stephane Rinfret, MD         
Sponsors and Collaborators
Matrizyme Pharma Corporation
Investigators
Principal Investigator: Christopher Buller, Dr. St. Michael's Hospital, Toronto, Ontario, Canada
  More Information

No publications provided

Responsible Party: Matrizyme Pharma Corporation
ClinicalTrials.gov Identifier: NCT01753180     History of Changes
Other Study ID Numbers: CTO-201
Study First Received: December 17, 2012
Last Updated: September 9, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Netherlands: Dutch Healthcare Authority

Keywords provided by Matrizyme Pharma Corporation:
CTO
PCI
Angioplasty

ClinicalTrials.gov processed this record on November 20, 2014