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
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
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