At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Comparison of Sirolimus-eluting Stent Implantation With Zotarolimus-eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions. The PRISON III Trial.
In Brief
A Phase 3 clinical trial evaluating sirolimus-eluting stent, zotarolimus-eluting stent for Coronary Artery Disease and 2 related conditions. Completed, enrolled 301 participants across 5 sites in 2 countries.
Detailed Summary
Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this prospective randomized trial, sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is in-segment late luminal loss at 8 month angiographic follow-up.
Study Details
Timeline
Interventions
PCI in chronically occluded coronary artery