Collagenase Total Occlusion Trial (CTO-201)

This study is not yet open for participant recruitment.
Verified February 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: February 12, 2014
Last verified: February 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 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: March 2014
Estimated Primary Completion Date: June 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
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

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: February 12, 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 April 17, 2014