Sponsor Name

BioHeart

Brief summary

RADIUS-HTN is a prospective, multi-center, multinational, randomized, 2-arm parallel groups study. The objective is to compare the safety and efficacy of radio frequency renal denervation using the Iberis Renal Denervation System (AngioCare) via radial access compared with femoral access. In parallel a registry is conducted for patients only eligible for radial access.

The aim is to include 90 patients in the randomized study. Estimated 20 patients should bee included in the registry.

Primary endpoint

• Change in office systolic blood pressure at 3 months (efficacy endpoint)

CERC Services

• Site selection
• Regulatory submissions
• Project management
• Contract management
• Monitoring
• SAE reporting
• CEC activities
• Data management
• Statistical Analysis

Countries

• France, Germany, Switzerland, China

Number of investigational sites: 12