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

NCT ID: NCT04190979

Last Updated: 2019-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-17
• Study Completion Date: 2019-02-25

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

TrackCath

Group Type: EXPERIMENTAL

Medyria TrackCath System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

StatConsult Gesellschaft für klinische und Versorgungsforschung mbH

UNKNOWN

Sponsor Role: collaborator

Axxos GmbH

UNKNOWN

Sponsor Role: collaborator

Worldwide Clinical Trials

OTHER

Sponsor Role: collaborator

Medical Mind RCS GmbH

UNKNOWN

Sponsor Role: collaborator

Medyria AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert Schelzig, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Heinrich-Heine University, Duesseldorf

Locations

Universitätsklinikum RWTH Aachen

Aachen, , Germany

Heinrich-Heine University Düsseldorf

Düsseldorf, , Germany

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Universitätklinikum Leipzig

Leipzig, , Germany

Countries

Germany

Other Identifiers

VP-000 214

Identifier Type: -

Identifier Source: org_study_id