Trial · NCT01271335
Collagenase Total Occlusion-1 Trial
NCT01271335, Phase 1, Completed, Sunnybrook Health Sciences Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Collagenase Total Occlusion-1 Trial. Trials, record NCT01271335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01271335
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Collagenase Total Occlusion-1 Trial
- NCT number
- NCT01271335
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Conditions
- Chronic Total Occlusions
- Interventions
- collagenase
- First posted
- 2011-01-06
- Last updated
- 2012-03-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety | At 3 months | * Major Adverse Cardiac events, AE and SAE. * Cardiac enzymes, hematology and biochemistry; changes between Screening relative to Days 1 \& 30. * Vital Signs * A 2D-echocardiogram examination will be done on Day1 (18-24 hours after the collagenase administration prior to the CTO crossing procedure) and again on Day2 prior to discharge. |
| Secondary | Efficacy | Day 2 | The efficacy endpoint of this study is guidewire crossing success rates in CTOs. A response rate of 30% or greater at a particular dose will support further clinical testing of MZ-004. |
| Secondary | Pharmacokinetic | PK blood draws will be assessed at 15, 30, 60, 120, 240, 480 min. and 18 hrs post removal of microcatheter | Subjects in the highest dose cohort, who are participating in the PK sub-study, will have blood draws taken post dose to prior to the PCI attempt on Day2. The blood draws will coincide with standard of care blood draws, whenever possible. 5 ml of blood will be drawn into a serum tube at each PK timepoint. All PK samples will be stored at -80 °C until the end of the study and analyzed together. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22179536 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01271335
GET https://conductscience.org/api/trials/v1/NCT01271335/registered