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

NCT04190979 | Completed

• 1 other identifier: VP-000 214
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Secondary Safety (All AEs)

  Up to discharge (expected to be within 1 month)

• Procedural Parameters (contrast dye)

  Intra-operative

• Procedural Parameters (procedural times)

  Intra-operative

• Procedural Parameters (Blood flow velocity)

  Intra-operative

• Surgeon satisfaction rate

  Intra-operative

Study Arms (1)

Single arm

EXPERIMENTAL

TrackCath

Device: Medyria TrackCath System

Interventions

Medyria TrackCath System 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.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medyria AG: lead
• StatConsult Gesellschaft für klinische und Versorgungsforschung mbH: collaborator
• Axxos GmbH: collaborator
• Worldwide Clinical Trials: collaborator
• Medical Mind RCS GmbH: collaborator

Study Sites (4)

Universitätsklinikum RWTH Aachen

Aachen, 52074, Germany

Location

Heinrich-Heine University Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Universitätklinikum Leipzig

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hubert Schelzig, Prof. Dr.

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: December 9, 2019
• Study Start: March 17, 2018
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)