Total Occlusion Study in Coronary Arteries - 5

NCT ID: NCT01753180

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Coronary Total Occlusions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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collagenase

Group Type EXPERIMENTAL

collagenase

Intervention Type BIOLOGICAL

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

saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

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

Interventions

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collagenase

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

Intervention Type BIOLOGICAL

saline

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

Intervention Type DRUG

Other Intervention Names

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MZ-004

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matrizyme Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Buller, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

CHUM Hotel Dieu

Montreal, Quebec, Canada

Site Status

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Site Status

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

Ste. Foy, Quebec, Canada

Site Status

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Canada Israel Netherlands

Other Identifiers

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CTO-201

Identifier Type: -

Identifier Source: org_study_id

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