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

NCT05445258 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-09-08

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • InnoRa GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Werk, Dr · Martin-Luther-Krankenhaus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2022-08-02
Completion
2022-08-02

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445258 on ClinicalTrials.gov