Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)

NCT04190979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-12-09

No results posted yet for this study

Summary

Pre-market, single-arm, prospective, open-label, multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients undergoing endovascular intervention.

Conditions

  • Aortic Aneurysm, Abdominal
  • Aortic Aneurysm, Thoracoabdominal
  • Acute Renal Failure
  • Acute Kidney Injury
  • Acute Kidney Failure
  • Acute Renal Insufficiency

Interventions

DEVICE

Medyria TrackCath System

The TrackCath System is a non-implantable device and consists of the TrackCath Catheter and the TrackCath Equipment. It is designed to support the successful positioning of third-party guidewires and catheters in the arterial vasculature to detect and cannulate side branches during endovascular aneurysm repair procedures through the measurement of real-time blood flow velocity changes.

Sponsors & Collaborators

  • StatConsult Gesellschaft für klinische und Versorgungsforschung mbH

    collaborator UNKNOWN
  • Axxos GmbH

    collaborator UNKNOWN
  • Worldwide Clinical Trials

    collaborator OTHER
  • Medical Mind RCS GmbH

    collaborator UNKNOWN
  • Medyria AG

    lead INDUSTRY

Principal Investigators

  • Hubert Schelzig, Prof. Dr. · Heinrich-Heine University, Duesseldorf

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-17
Primary Completion
2019-02-25
Completion
2019-02-25

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT04190979 on ClinicalTrials.gov