Collagenase Total Occlusion-1 Trial

Summary

A prospective, three-center, phase I safety and tolerability dose escalation study, evaluating 28 subjects in 4 discrete dose cohorts of acute intracoronary injected collagenase ranging from 300 - 1200 µg prior to routine standard-of-care percutaneous revascularization procedures in subjects with chronic total coronary artery occlusions (CTOs).

Timeline

Start

2009-11

Primary completion

2011-09

Completion

2012-02

Publications

• Strauss BH, Osherov AB, Radhakrishnan S, Mancini GB, Manners A, Sparkes JD, Chisholm RJ. Collagenase Total Occlusion-1 (CTO-1) trial: a phase I, dose-escalation, safety study. Circulation. 2012 Jan 24;125(3):522-8. doi: 10.1161/CIRCULATIONAHA.111.063198. Epub 2011 Dec 16.

Drugs

Indications