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

Not Applicable

Completed

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

• Registration Number: NCT04190979
• Lead Sponsor: Medyria AG

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.

Study Timeline

• Study Start: 2018-03-17
• Primary Completion: 2019-02-25
• Study Completion: 2019-02-25
• Study First Submitted: 2019-11-14
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-05
• Last Update Submitted: 2019-12-05
• Study First Posted: 2019-12-09
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary Safety (All AEs)	Up to discharge (expected to be within 1 month)	All Adverse Events
Procedural Parameters (contrast dye)	Intra-operative	Amount of contrast dye used (ml)
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).
Procedural Parameters (Blood flow velocity)	Intra-operative	Blood flow velocity changes between above orifice and at orifice (m/s).
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).

Trial Locations

Locations (4)

Universitätsklinikum RWTH Aachen; 🇩🇪 Aachen, Germany

Heinrich-Heine University Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Universitätklinikum Leipzig; 🇩🇪 Leipzig, Germany