NCT05531578

Transfemoral Implant of Inovare® Transcatheter Valve

Transfemoral Implant of Inovare® Transcatheter Valve - Clinical Trial of Feasibility and Safety and Efficacy Verification

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.

Detailed description

The Inovare® transcatheter valve was developed and has been market ed since 2011 for replacement, via transapical or transaortic route, of calcified native aortic valves and degenerated bioprostheses (aortic and mitral) with satisfactory medium-long-term results. The present study aims to evaluate the safety and clinical performance of the new navigation and delivery system of this device using the transfemoral route. The new device has as its main feature the drivable control of the curvature of the delivery system, the which allows better navigability in regions of more complex anatomy, especially with accentuated tortuosities.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)	Transfemoral implantation of the INOVARE® transcatheter valve

Timeline

• Start date: 2020-09-11
• Primary completion: 2024-02-20
• Completion: 2028-12-30
• First posted: 2022-09-08
• Last updated: 2024-01-11

Locations

4 sites across 1 country: Brazil