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

Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) - A Prospective Multi-centre Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Acute Renal Failure; Aortic Aneurysm, Abdominal; Acute Kidney Failure; Acute Renal Insufficiency; Aortic Aneurysm, Thoracoabdominal
• Intervention / Treatment: Device: Medyria TrackCath System

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum RWTH Aachen
  • Düsseldorf, Germany, 40225
    • Heinrich-Heine University Düsseldorf
  • Hamburg, Germany, 20246
    • Universitäres Herzzentrum Hamburg
  • Leipzig, Germany, 04103
    • Universitätklinikum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm; TrackCath

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success Rate	Successful TrackCath delivery of the distal end of the guidewire or of the 4 French catheter to the selected targeted orifice(s).	Intra-operative
Primary Safety (All SADEs)	Occurrence of Serious Adverse Device Effects (SADE)	Up to discharge (expected to be within 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety (All AEs)	All Adverse Events	Up to discharge (expected to be within 1 month)
Procedural Parameters (contrast dye)	Amount of contrast dye used (ml)	Intra-operative
Procedural Parameters (procedural times)	Exposure time to X-ray (min); total duration of the procedure (min); duration of the target orifice identification and cannulation (min).	Intra-operative
Procedural Parameters (Blood flow velocity)	Blood flow velocity changes between above orifice and at orifice (m/s).	Intra-operative
Surgeon satisfaction rate	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).	Intra-operative

Collaborators and Investigators

• Sponsor: Medyria AG
• Collaborators: Worldwide Clinical Trials; StatConsult Gesellschaft für klinische und Versorgungsforschung mbH; Axxos GmbH; Medical Mind RCS GmbH
• Investigators: Principal Investigator: Hubert Schelzig, Prof. Dr., Heinrich-Heine University, Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2018
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: AAA; EVAR; Endovascular aneurysm repair; Cannulation; Blood Flow Velocity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Aortic Diseases; Renal Insufficiency; Acute Kidney Injury; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: VP-000 214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No