At a glance
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Approaches to Chronic Occlusions With Sirolimus Stents-Cypher (ACROSS-Cypher) Total Occlusion Study of Coronary Arteries 4 Trial
In Brief
A Phase 3 clinical trial evaluating Cypher sirolimus eluting coronary stent for Coronary Occlusions. Completed, enrolled 200 participants across 16 sites in 2 countries.
Detailed Summary
ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be used as the historical control. The hypothesis is that compared with TOSCA-1 patients who were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher® sirolimus eluting coronary stent will result in a \>50% relative reduction in 6 month restenosis within the treated segment of the target vessel.
Study Details
Timeline
Interventions
Cypher® sirolimus eluting coronary stent ranging in diameters 2.5 to 3.5 mm and available in length from 8 to 33 mm.