Chronic Coronary Total OcclusionsPhase 2TOSCA-5NCT01753180
Total Occlusion Study in Coronary Arteries - 5
A Phase 2 study testing collagenase and saline in people with Chronic Coronary Total Occlusions, run by Matrizyme Pharma Corporation at 13 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Coronary Total Occlusions
- What is being tested?
- collagenase and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Apr 2014to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Canada11 sites
Foothills Medical Centre
Calgary, Alberta, T2N 4Z6
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre
London, Ontario, N6A 5A5
CHUM Hotel Dieu
Montreal, Quebec, H2W 1T8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Centre de recherche de l'Institut Universitaire de Pulmonologie et Cardiologie de Quebec
Ste. Foy, Quebec, G1V 4G5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
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
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).
- Conditions
- Chronic Coronary Total Occlusions
- Being tested
- collagenase, saline
- Keywords
- CTO, PCI, Angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagenaseBiological
Also called MZ-004
Local intra-coronary administration of MZ-004 at or into the CTO
salineDrug
Local intra-coronary administration of saline at or into the CTO
| Study group | Role | What they receive |
|---|---|---|
| collagenase | Experimental | Not described Receives: Biological: collagenase |
| saline | Placebo comparator | Not described Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 of study procedures
Secondary outcomes (4)
Total fluoroscopy time
To assess the total fluoroscopy time between patients treated with two different doses of MZ-004 and/or placebo
Measured: Day 0 and Day 1 of study procedures
Total PCI procedural time
To assess the total procedural time between patients treated with two different doses of MZ-004 and/or placebo
Measured: Day 1 of study procedures
Soft wire crossing
To assess the percentage of lesions that are crossed with soft guide wires post study drug administration
Measured: Day 1 study procedures
Safety
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
Measured: Day 0, Day 1 and Day 2 of study procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary Total OcclusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matrizyme Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Buller, Dr., Principal investigator, St. Michael's Hospital, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753180
- Sponsor's protocol ID
- CTO-201
- Acronym
- TOSCA-5
- Status last verified
- Jul 2016
- First submitted
- 17 Dec 2012
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01753180
- Acronym / sponsor ID
- TOSCA-5 / CTO-201
- Conditions
- Chronic Coronary Total Occlusions
- Keywords
- CTO, PCI, Angioplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Matrizyme Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| collagenase | Experimental | Biological: collagenase |
| saline | Placebo comparator | Drug: saline |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagenaseAlso: MZ-004Local intra-coronary administration of MZ-004 at or into the CTO | Biological | collagenase |
| salineLocal intra-coronary administration of saline at or into the CTO | Drug | saline |
Primary outcome
Anterograde PCI success rate for patients with a target CTO
Time frame: Day 1 of study procedures
To assess the PCI success rates in CTOs that have failed a previous PCI attempt between different doses of MZ-004 and placebo
4 secondary outcomes
Total fluoroscopy time
Time frame: Day 0 and Day 1 of study procedures
Total PCI procedural time
Time frame: Day 1 of study procedures
Soft wire crossing
Time frame: Day 1 study procedures
Safety
Time frame: Day 0, Day 1 and Day 2 of study procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Buller, Dr. principal investigator
St. Michael's Hospital, Toronto, Ontario, Canada
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing collagenase and saline in people with Chronic Coronary Total Occlusions, run by Matrizyme Pharma Corporation at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Israel, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterograde PCI success rate for patients with a target CTO (time frame: Day 1 of study procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.