NCT05445258

Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon

Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: InnoRa GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries.

Conditions

• Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II

Interventions

Type	Name	Description
DEVICE	InnoCath AB® hyper-compliant balloon catheter	endovascular treatment of lesions in the superficial femoral artery (SFA) and/or popliteal artery pars I/II without further luminal widening, and/or for short-term interruption of blood flow with the InnoCath AB® hyper-compliant balloon cathe-ters (100 or 200 mm length)

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2022-07-06
• Last updated: 2022-09-08

Locations

2 sites across 1 country: Germany