Acute Kidney Injury Clinical Trial
— ACCESSOfficial title:
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) - A Prospective Multi-centre Clinical Trial.
Verified date | December 2019 |
Source | Medyria AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 25, 2019 |
Est. primary completion date | February 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum RWTH Aachen | Aachen | |
Germany | Heinrich-Heine University Düsseldorf | Düsseldorf | |
Germany | Universitäres Herzzentrum Hamburg | Hamburg | |
Germany | Universitätklinikum Leipzig | Leipzig |
Lead Sponsor | Collaborator |
---|---|
Medyria AG | Axxos GmbH, Medical Mind RCS GmbH, StatConsult Gesellschaft für klinische und Versorgungsforschung mbH, Worldwide Clinical Trials |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Primary Safety (All SADEs) | Occurrence of Serious Adverse Device Effects (SADE) | Up to discharge (expected to be within 1 month) | |
Secondary | Secondary Safety (All AEs) | All Adverse Events | Up to discharge (expected to be within 1 month) | |
Secondary | Procedural Parameters (contrast dye) | Amount of contrast dye used (ml) | Intra-operative | |
Secondary | 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 | |
Secondary | Procedural Parameters (Blood flow velocity) | Blood flow velocity changes between above orifice and at orifice (m/s). | Intra-operative | |
Secondary | 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 |
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