Trials / Completed
CompletedNCT04190979
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) - A Prospective Multi-centre Clinical Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Medyria AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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 above the age of 18 years who have been diagnosed with aneurysms in the thoracoabdominal (TAAA) or abdominal (AAA) aorta and require endovascular intervention. The TrackCath System is a non-implantable disposable device, intended to measure real-time changes in the Blood Flow Velocity and to provide a pathway for delivering third-party guidewires and/or catheters. Following patient consent, data is collected until discharge. To reach 80% power, a total number of 32 patients (minimum 42 target orifices) is scheduled, including a minimum of 8 roll-in patients for the training phase, which comprises at least two successful cases per center.
Conditions
- Aortic Aneurysm, Abdominal
- Aortic Aneurysm, Thoracoabdominal
- Acute Renal Failure
- Acute Kidney Injury
- Acute Kidney Failure
- Acute Renal Insufficiency
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-03-17
- Primary completion
- 2019-02-25
- Completion
- 2019-02-25
- First posted
- 2019-12-09
- Last updated
- 2019-12-09
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04190979. Inclusion in this directory is not an endorsement.