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

Medyria

Status

Completed

Conditions

Acute Kidney Failure

Acute Kidney Injury

Aortic Aneurysm, Thoracoabdominal

Acute Renal Insufficiency

Aortic Aneurysm, Abdominal

Acute Renal Failure

Treatments

Device: Medyria TrackCath System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04190979

VP-000 214

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.