Principal Investigator:
Morris Mosseri MD, Hisham Nassar MD

Sponsor
Medtronic, Holland/Switzerland

Monitor
Medtronic Israel

Abstract

The potential benefits of the so called "direct stenting" strategy, i.e. stent delivery without pre-dilation , are less trauma to the vessel wall, faster procedure, less radiation exposure and cost saving due to the use of less materials (pr-dilation balloons and contrast agents). Over the years stent delivery systems have been improved significantly, especially with regard to the crossing profile and the attachement of the stent delivery ballon, therefore direct stenting was considered less riskful and has been further evaluated. In this study the acute and mid-term performance of the Medtronic BeStent2 will be determined, using either the direct stenting strategy or stenting with pr-dilation, in a reference population consisting of patients with stable or unstable angina pectoris requiring intervention of one or two lesion(s).
The study objective is to assess the safety and efficacy of BeStent2 implantation in patients with (un)stable angina pectoris with a planned intervention in one or two lesions in the native coronary artery system applying either the direct stenting or a pre-dilation strategy, according to the physician's preference.

Status
Ongoing trial, post-marketing