Clinical trial NCT01753180: Total Occlusion Study in Coronary Arteries - 5
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Coronary Total Occlusions
Keywords: CTO
PCI
Angioplasty
Lead sponsor: Matrizyme Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Anterograde PCI success rate for patients with a target CTO
timeFrame: Day 1 of study procedures
Secondary outcomes:
measure: Total fluoroscopy time
timeFrame: Day 0 and Day 1 of study procedures
measure: Total PCI procedural time
timeFrame: Day 1 of study procedures
measure: Soft wire crossing
timeFrame: Day 1 study procedures
measure: Safety
timeFrame: Day 0, Day 1 and Day 2 of study procedures
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM Hotel Dieu
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Ste. Foy
country: Canada
facility: Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec
state: Quebec
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: St. Michael's Hospital, Toronto, Ontario, Canada
name: Christopher Buller, Dr.
role: PRINCIPAL_INVESTIGATOR
References: