COBRA PzF Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization, and Avoiding Long-Term Dual Anti-Platelet Therapy – The PzF SHIELD Trial
Completed · 2013 until 2021
Weilenmann Daniel, Schneider Irene, Schefer Mirjam
The main objective of this study is to evaluate the safety and effectiveness of the COBRA PzF Coronary Stent System in the treatment of de novo lesions in native coronary arteries. The COBRA PzF Coronary Stent System is a balloon-expandable bare metal coronary stent with a nanothin surface treatment of novel Polyzene-F polymer on a low-profile rapid-exchange delivery system.
The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the COBRA PzF Coronary Stent System. This rate will be compared to a performance goal derived using a meta-analysis from published historical data of the standard-of-care therapy, coronary stenting with bare metal stents.