Clinical trial NCT04190979: Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)
Official title: Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) - A Prospective Multi-centre Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracoabdominal
Acute Renal Failure
Acute Kidney Injury
Acute Kidney Failure
Acute Renal Insufficiency
Keywords: Endovascular aneurysm repair
EVAR
AAA
Cannulation
Blood Flow Velocity
Lead sponsor: Medyria AG
Sponsor class: INDUSTRY
Collaborators: name: StatConsult Gesellschaft für klinische und Versorgungsforschung mbH
name: Axxos GmbH
name: Worldwide Clinical Trials
name: Medical Mind RCS GmbH
First posted: 2019-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural Success Rate
timeFrame: Intra-operative
measure: Primary Safety (All SADEs)
timeFrame: Up to discharge (expected to be within 1 month)
Secondary outcomes:
measure: Secondary Safety (All AEs)
timeFrame: Up to discharge (expected to be within 1 month)
measure: Procedural Parameters (contrast dye)
timeFrame: Intra-operative
measure: Procedural Parameters (procedural times)
timeFrame: Intra-operative
measure: Procedural Parameters (Blood flow velocity)
timeFrame: Intra-operative
measure: Surgeon satisfaction rate
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum RWTH Aachen
city: Düsseldorf
country: Germany
facility: Heinrich-Heine University Düsseldorf
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Leipzig
country: Germany
facility: Universitätklinikum Leipzig
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Hubert Schelzig, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: