NCT07087639

Novel Venous Cannula Trial

Safety and Effectiveness Evaluation of Novel MICS Venous Cannula

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Eurosets S.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous cannulation. The investigation aims to assess the pressure drop across the cannula during extracorporeal circulation and the incidence of serious adverse events associated with its use. A total of 42 participants will be enrolled.

Detailed description

This clinical investigation evaluates a Novel Venous Cannula intended for drainage of venous blood during extracorporeal circulation in cardiac surgery. The cannula is made of polyurethane and includes a flexible metallic mesh that allows it to collapse during insertion and expand in situ. It is designed for single use, sterile, and is introduced using a dedicated insertion kit. The study is a non-randomized, open-label, monocentric, single-arm investigation involving 42 adult patients undergoing elective cardiac surgery requiring transfemoral venous cannulation. The investigation includes three visits: a screening visit (from Day -7 to Day -1), the procedure day (Day 0), and a follow-up visit at Day 7 ± 3 days. The primary effectiveness outcome is the mean pressure drop (mm Hg) across the cannula required to maintain the target flow rate during surgery. The primary safety outcome is the number of serious adverse events (SAEs) related to the use of the investigational device. Secondary outcomes include several efficacy-related parameters (e.g., venous line flow, pump flow, cannula positioning, volume of infusion, cardioplegic solution usage, and others), as well as safety outcomes including mortality, cardiovascular events, and neurological complications at 7 days post-procedure. There is no control group in this study.

Conditions

• Cardiac Surgery
• Heart Surgery
• Cardiopulmonary Bypass
• Minimally Invasive Surgical Procedures

Interventions

Type	Name	Description
DEVICE	Self-expanding Venous Cannula	The intervention consists of a self-expanding venous drainage cannula made of polyurethane and reinforced with a flexible metallic mesh. It is designed for transfemoral insertion during on-pump cardiac surgery, including minimally invasive procedures. Once positioned, the cannula expands to its functional diameter to facilitate efficient blood drainage into the extracorporeal circulation system. The configuration used in this study is 680/730 mm in length, 24 Fr, 3/8" diameter. The device is sterile, single-use, and is inserted once on the day of surgery (Day 0) and removed at the end of the procedure. The cannula is used continuously during cardiopulmonary bypass for a maximum duration of 6 hours and is not reused.

Timeline

• Start date: 2022-12-22
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: Italy