Principal Investigator:
Chaim Lotan MD

Sponsor:
Jomed

Abstract:

The primary objective of this study is to compare bare stents to PTFE-covered stents in patients with saphenous vein graft disease with respect to major adverse cardiac advents (MACE) at 6 months. The secondary objectives are to compare the two treatment arms with respect to MACE at 1 and 12 months, angiographic restenosis rate at 6 months as assessed by off-line quantitative coronary angiography, cost effectiveness at hospital discharge, as well as at 6 months and 12 months, respectively, and safety of the treatment (thrombotic occlusion and bleeding and vascular complications and all other serious adverse events).

Status:
Ongoing trial