PERFORMANCE II Evaluates Contego’s Neuroguard IEP Carotid Stent System at 2 Years

November 4, 2024—The safety and effectiveness of the Neuroguard IEP (Contego Medical)—a three-in-one carotid stent system with integrated embolic protection (IEP)— were evaluated at 2 years in the PERFORMANCE II study. The prospective, multicenter, single-arm, open-label study assessed the device for the treatment of carotid artery stenosis in patients at elevated risk for adverse events following carotid endarterectomy.

William A. Gray, MD, presented the findings in the second late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

The VIVA24 press release reported that the PERFORMANCE II study enrolled 305 patients at 32 sites in the United States and Europe. The primary endpoint was the 30-day rate of major adverse events (MAEs; defined as death, all stroke, and myocardial infarction [MI]) within 30 days of the index procedure, plus ipsilateral stroke through 12 months of the procedure. Events were adjudicated by an independent clinical events committee. Imaging was analyzed by an independent core lab.

In the study, 20% of patients were symptomatic and 43.5% were diabetic. Additionally, 75% of patients presented with physiologic high-risk criteria, 25% patients had anatomic high-risk criteria, and 28% had both. The mean target lesion stenosis was 85% and 34% were severely calcified.

The VIVA24 press release summarized the following results:

• In a per-protocol analysis, the 30-day stroke rate was 1%.
• In an intention-to-treat analysis, the 30-day stroke rate was 1.3%.
• The death/stroke rate was 1.6%.
• The death/stroke/MI rate was 2.3%.
• The rate of 30-day all-stroke plus ipsilateral stroke through 1 year was 1.8%, all of which were minor.
• There were no major strokes, stent thrombosis, or neurologic deaths through 2 years.
• The rate of in-stent restenosis (ISR) was 3.65% at 1 year and 3.85% at 2 years.
• There was no clinically driven target lesion revascularization (CD-TLR) at 1 year and one CD-TLR (0.36%) at 2 years.

As stated in the VIVA24 press release, the study concluded that the 2-year PERFORMANCE II results demonstrated the procedural safety and long-term durability of the Neuroguard IEP 3-in-1 carotid stent system in high-surgical-risk patients. Additionally, despite a 43.5% rate of diabetes and 34% rate of severe calcification, the 3.85% rate of ISR and 0.36% rate of CD-TLR at 2 years were very low.

On October 15, 2024, Contego Medical announced FDA premarket approval of the Neuroguard IEP system.