NCT01753180

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
3 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

December 17, 2012

Last Update Submit

July 7, 2016

Conditions

Chronic Coronary Total Occlusions

Keywords

CTOPCIAngioplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Total fluoroscopy time

    Day 0 and Day 1 of study procedures

  • Total PCI procedural time

    Day 1 of study procedures

  • Soft wire crossing

    Day 1 study procedures

  • Safety

    Day 0, Day 1 and Day 2 of study procedures

Study Arms (2)

collagenase

EXPERIMENTAL
Biological: collagenase

saline

PLACEBO COMPARATOR
Drug: saline

Interventions

collagenaseBIOLOGICAL

Local intra-coronary administration of MZ-004 at or into the CTO

Also known as: MZ-004
collagenase
salineDRUG

Local intra-coronary administration of saline at or into the CTO

saline

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Foothills Medical Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

CHUM Hotel Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec

Ste. Foy, Quebec, G1V 4G5, Canada

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Interventions

CollagenasesSodium Chloride

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Christopher Buller, Dr.

    St. Michael's Hospital, Toronto, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

CA(11)NL(1)IL(1)