Acute Kidney Failure, Acute Kidney Injury, Acute Renal Failure, Acute Renal Insufficiency, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Conditions
Keywords
Endovascular aneurysm repair, EVAR, AAA, Cannulation, Blood Flow Velocity
Brief 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.
Interventions
DEVICEMedyria 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
StatConsult Gesellschaft für klinische und Versorgungsforschung mbH
Axxos GmbH
Worldwide Clinical Trials
Medical Mind RCS GmbH
Medyria AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has signed and understood the approved Informed Consent form and is able to meet the proposed study proceedings (CIP). * Patient is ≥18 years of age * Need for standard or complex EVAR of AAA according to the relevant guidelines: * Asymptomatic aneurysms with a diameter \> 55mm in men and \> 50 mm in woman * Aneurysm-growth exceeds 10mm/year * Patient requires at least one cannulation during which requires at least one cannulation (e.g. fenestration of endograft, side-branch and/or contralateral leg of endograft)
Exclusion criteria
* Patient is generally contraindicated for EVAR * Patient requires an emergency surgery * Patient with an increased risk of aneurysm rupture or saccular aneurysm, aneurysm with isolated wall protuberances or penetrating aortic ulcer * Patient with a dissecting acutely ruptured or leaking aneurysm or an acute vascular injury caused by a trauma * Patient with stroke or transient ischemic attack (TIA) within the last 6 months prior to baseline * Patient with myocardial infarction (MI) with the last 3 months prior to baseline * Patient with acute or chronic renal failure (including dialysis); Creatinine \> 2.00 mg/dl or \> 182 µmol/L * Patient with co-morbidities that constitutes an unacceptable risk (for example chronic obstructive pulmonary disease (COPD), liver failure, immunosuppression, polyneuropathy and hematological diseases) * Patient with bleeding history or coagulopathy * Patient with contraindication or allergies to take anticoagulants, antiplatelet drugs or contrast media * Life expectancy of less than 5 years * Female patient that is pregnant, is planning on becoming pregnant in the next month or is breastfeeding * Patient with inability to obtain vascular access * Patient has an active local or systemic infection * Patient is currently participating in another investigational study where the endpoints have not yet been achieved * Patient has a mental illness, and/or been diagnosed as clinically depressed or belongs to a vulnerable population (e.g., prisoner, severe drug abuser, developmentally disabled) that would compromise the ability to provide informed consent. * Patient has an obstructed or inadequate vasculature by means of tortuous anatomy hindering the TC catheter to reach target orifice(s) * Patient has an elevated risk of plaque dislodgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success Rate | Intra-operative | Successful TrackCath delivery of the distal end of the guidewire or of the 4 French catheter to the selected targeted orifice(s). |
| Primary Safety (All SADEs) | Up to discharge (expected to be within 1 month) | Occurrence of Serious Adverse Device Effects (SADE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Parameters (procedural times) | Intra-operative | Exposure time to X-ray (min); total duration of the procedure (min); duration of the target orifice identification and cannulation (min). |
| Secondary Safety (All AEs) | Up to discharge (expected to be within 1 month) | All Adverse Events |
| Surgeon satisfaction rate | Intra-operative | Surgeon satisfaction on the use of the TrackCath catheter and the Blood Flow Velocity sensor, expressed on a scale from 1 (very bad) to 5 (very good). |
| Procedural Parameters (Blood flow velocity) | Intra-operative | Blood flow velocity changes between above orifice and at orifice (m/s). |
| Procedural Parameters (contrast dye) | Intra-operative | Amount of contrast dye used (ml) |
Countries
Germany
Outcome results
None listed