Aortic Aneurysm, AbdominalACCESSNCT04190979
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)
A study testing Medyria TrackCath System in people with Aortic Aneurysm, Abdominal and Aortic Aneurysm, Thoracoabdominal, run by Medyria AG at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Acute Renal Failure
- What is being tested?
- Medyria TrackCath System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesGermany
- Study dates
- 17 Mar 2018to 25 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Universitätsklinikum RWTH Aachen
Aachen, 52074
Heinrich-Heine University Düsseldorf
Düsseldorf, 40225
Universitäres Herzzentrum Hamburg
Hamburg, 20246
Universitätklinikum Leipzig
Leipzig, 04103
About this study
Official title: 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.
Read the 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
- Being tested
- Medyria TrackCath System
- Keywords
- Endovascular aneurysm repair, EVAR, AAA, Cannulation, Blood Flow Velocity
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medyria TrackCath SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | TrackCath Receives: Device: Medyria TrackCath System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Intra-operative
Primary Safety (All SADEs)
Occurrence of Serious Adverse Device Effects (SADE)
Measured: Up to discharge (expected to be within 1 month)
Secondary outcomes (5)
Secondary Safety (All AEs)
All Adverse Events
Measured: Up to discharge (expected to be within 1 month)
Procedural Parameters (contrast dye)
Amount of contrast dye used (ml)
Measured: 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).
Measured: Intra-operative
Procedural Parameters (Blood flow velocity)
Blood flow velocity changes between above orifice and at orifice (m/s).
Measured: 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).
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start17 Mar 2018
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medyria AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- StatConsult Gesellschaft für klinische und Versorgungsforschung mbH, Axxos GmbH, Worldwide Clinical Trials, Medical Mind RCS GmbH
- Responsible party
- Sponsor
- Investigators
- Hubert Schelzig, Prof. Dr., Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190979
- Sponsor's protocol ID
- VP-000 214
- Acronym
- ACCESS
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA) - A Prospective Multi-centre Clinical Trial.
- ClinicalTrials.gov ID
- NCT04190979
- Acronym / sponsor ID
- ACCESS / VP-000 214
- 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 type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medyria AGIndustry (pharma, biotech, devices)
- Collaborators
- StatConsult Gesellschaft für klinische und Versorgungsforschung mbH, Axxos GmbH, Worldwide Clinical Trials, Medical Mind RCS GmbH
- Study start
- 17 Mar 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Medyria TrackCath SystemTrackCath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medyria TrackCath SystemThe 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. | Device | Single arm |
Primary outcome
Procedural Success Rate
Time frame: Intra-operative
Successful TrackCath delivery of the distal end of the guidewire or of the 4 French catheter to the selected targeted orifice(s).
Primary Safety (All SADEs)
Time frame: Up to discharge (expected to be within 1 month)
Occurrence of Serious Adverse Device Effects (SADE)
5 secondary outcomes
Secondary Safety (All AEs)
Time frame: Up to discharge (expected to be within 1 month)
Procedural Parameters (contrast dye)
Time frame: Intra-operative
Procedural Parameters (procedural times)
Time frame: Intra-operative
Procedural Parameters (Blood flow velocity)
Time frame: Intra-operative
Surgeon satisfaction rate
Time frame: Intra-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Schelzig, Prof. Dr. principal investigator
Heinrich-Heine University, Duesseldorf
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medyria TrackCath System in people with Aortic Aneurysm, Abdominal and Aortic Aneurysm, Thoracoabdominal, run by Medyria AG at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success Rate (time frame: Intra-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.