Principal Investigators
Chaim Lotan MD, Refat Jabara MD

Sponsor
Medinol

Monitor
Harrison Clinical Research Israel L.P.

Abstract
The study will evaluate the safety and effectiveness of the NIRFLEXTM and NIRFLEXTM Royal Stent Systems in the treatment of stenotic lesions in native coronary arteries, and to compare the response of vascular implantation between stainless steel and gold-coated stents. This is a multi-center, prospective, randomized, two-armed controlled clinical trial of parallel design. The trial will be conducted at 17 sites worldwide. A total of 300 patients (150 patients each arm) will be enrolled. The expected duration of patient enrollment is approx. 3-4 months. Patients will subsequently be followed for 6 month after treatment. Results of both treatment groups will be compared to historical control data of the approved NIR R Stent.

Status
Waiting for Helsinki approval