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

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

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

NCT04190979•Medyria AG

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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
+8 more criteria

Locations (4)

Universitätsklinikum RWTH Aachen

Aachen, Germany

Heinrich-Heine University Düsseldorf

Düsseldorf, Germany

Universitäres Herzzentrum Hamburg

Hamburg, Germany

Universitätklinikum Leipzig

Leipzig, Germany

Key Dates

Start Date

March 17, 2018

Primary Completion Date

February 25, 2019

Completion Date

February 25, 2019

Last Updated

December 9, 2019

Enrollment

ACTUAL participants

Conditions

Aortic Aneurysm, AbdominalAortic Aneurysm, ThoracoabdominalAcute Renal FailureAcute Kidney InjuryAcute Kidney FailureAcute Renal Insufficiency

Interventions

Medyria TrackCath System

DEVICE

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

NCT04503395

Aortic Aneurysm, Abdominal

View study

RECRUITING

QoL After Complex Endovascular Aortic Repair

NCT05774938

Quality of LifeAortic Aneurysm+1 more

View study

RECRUITING

Standardized Physician-modified Fenestrated Endograft Registry

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

QoL After Complex Endovascular Aortic Repair

Standardized Physician-modified Fenestrated Endograft Registry

Kidney Precision Medicine Project

Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts

Pilot Study of BAO-G Technique in TAAA Endovascular Repair