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 - Projekt

Projekt

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

Abgeschlossen · 2013 bis 2021

Weilenmann Daniel, Schneider Irene, Schefer Mirjam

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Kardiologie

Status

Abgeschlossen

Start

2013

Ende

2021

Finanzierungsart

Industrie

Studiendesign

Prospective, multi-center, non-randomized, single arm clinical trial, conducted at up to 40 sites in the United States and OUS. Enrolling 296 patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery amenable to percutaneous coronary intervention (PCI) and stent deployment. Follow-up at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years post index stenting procedure.

Schlagwörter (Tags)

Cobra, Stent, Medizinprodukt

Kurzbeschreibung/Zielsetzung

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.