Contego Medical has announced that enrolment of the PERFORMANCE II clinical trial has been completed.
PERFORMANCE II is intended to evaluate the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) three-in-one carotid stent and post-dilation balloon system with IEP. The Neuroguard IEP system is designed to treat clinically significant carotid artery stenosis while improving procedural safety through the integration of the stent, balloon and an embolic filter, all in a single device.
“The Neuroguard IEP system combines a truly innovative stent design with a multi-function delivery platform for advanced protection from stroke, while reducing the number of catheter exchanges needed to complete the procedure,” said Christopher Metzger (Holston Valley Medical Center, Kingsport, USA), lead enroller in the trial. “Additionally, it has outstanding conformability for a closed-cell stent, allowing the advantages of this stent system in a wide variety of carotid anatomies.”
PERFORMANCE II is a prospective, multicentre, single-arm, open-label study for the treatment of carotid artery stenosis in subjects at high risk for carotid endarterectomy (CEA). The trial enrolled 305 patients at 32 sites in the USA and Europe. The principal investigators of the study are William Gray (Main Line Health, Wynnewood, USA) and Ralf Langhoff (Sankt Gertrauden Hospital, Berlin, Germany). Results of the study will be used to support a US Food and Drug Administration (FDA) premarket approval application.
“The Neuroguard IEP technology may offer significant benefits to patients suffering from severe carotid stenosis, specifically with the potential to lower the embolic burden and overall stroke rates,” said Gray.
“This is a well-executed clinical trial that is designed to demonstrate that the Neuroguard IEP system is both safe and effective,” added Stacy Enxing Seng, chairman of the board of Contego. “We believe that, once available, the Neuroguard IEP system has the potential to be the standard of care for the treatment of extracranial carotid disease.”
The Neuroguard IEP system is designed to safeguard against stroke by integrating a novel, next-generation stent, a pre-positioned post-dilation balloon, and a micro-embolic filter. The stent has a closed-cell design with FlexRing technology for optimal balance of plaque coverage, radial strength, and flexibility, according to a Contego press release. The integrated 40μm filter is designed to capture more micro-embolic debris than traditional filters.
Ravish Sachar, CEO and founder of Contego, commented: “Completing enrolment in PERFORMANCE II is a critical milestone on our path to bring this state-of-the-art technology to patients with carotid artery disease. We are extremely grateful to the physicians and patients who participated in this important study.”