End-stage Renal DiseaseNCT03454113
Ellipsys Vascular Access System Registry
An observational study of End-stage Renal Disease, run by Medtronic Endovascular at 5 sites in Germany.
Trial summary
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Ellipsys Vascular Access
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Jul 2017to 30 Jul 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with End-Stage Renal Disease or chronic kidney disease who provide written informed consent; who are currently require dialysis or it is anticipated will need dialysis within six months of enrollment; who meet all inclusion criteria and none of the exclusion criteria; and who are considered eligible for enrollment.
Who may be able to join
- Diagnosed with End-Stage Renal Disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment.
- Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment Adequate quality vein base on pre-operative assessment:
- Vein diameter of > 2.0 mm at target anastomosis site
- Clinically significant outflow as determined by outflow mapping (ultrasound or v venography)
- Adequate quality artery base on pre-operative assessment:
- Arterial lumen diameter of > 2.0 mm at target anastomosis site
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- No significant calcification at the anastomosis site
- Radial artery at the wrist suitable for catheterization
- Radial artery-adjacent vein proximity < 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
- Patent palmar arch with adequate collateral perfusion as evidenced by Negative Allen's Test
- Able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant)
Who cannot join
- Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
- History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
- Evidence of clinically significant vascular disease at the radial artery/adjacent vein site on the ipsilateral side
- Systolic pressures < 100 mg Hg at the time of treatment
- Suspected or confirmed skin disease at the skin entry site
- Immunocompromised patients (e.g. HIV positive)
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- Edema of the upper extremity on the ipsilateral side
- Patients requiring immunosuppressant therapy such as Sirolimus (Rapamune®) or - Prednisone at a dose of > 10 mg per day
- Peripheral white blood cell count <1.5 K/mm3 or platelet count <75,000 cells/mm3
- Known bleeding diathesis or coagulation disorder
- Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
- Patients with acute or active infection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, 79189
Universitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinikum Münster
Münster, 48149
Universitätsklinikum des Saarlandes
Saarbrücken, 66111
Ammerland Klinik
Westerstede, 26655
About this study
Official title: Ellipsys Vascular Access System Registry, Protocol 1.0. Version 1.0
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an arteriovenous (AV) fistula via percutaneous access.
Read the detailed description
Ellipsys Vascular Access System Registry is a non-randomized, prospective, post-market, multi-center registry of the Ellipsys Vascular Access System in which up to 100 patients will be enrolled to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an AV fistula via percutaneous access. The primary performance endpoint is Clinical Success at the 90-day endpoint, where Clinical Success is defined as an access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.
- Conditions
- End-stage Renal Disease
- Being tested
- Ellipsys Vascular Access
- Keywords
- dialysis autogenous arterio-venous fistula
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellipsys Vascular AccessDevice
The Ellipsys Vascular Access System comprises the Ellipsys Catheter, Ellipsys Crossing Needle and Ellipsys Power Controller. The Ellipsys Crossing Needle is used to facilitate access between the artery and the vein. The Ellipsys Catheter is placed percutaneously into the selected vein in close proximity to the selected artery. The Ellipsys Catheter is actuated at the selected anastomosis site, and the vein and artery are approximated. Once the vessels are in the appropriate relative positions the catheter is connected to the Ellipsys Power Controller to create the anastomosis after which the Ellipsys Catheter is removed, and the access site is closed using standard percutaneous closure techniques.
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with a vascular access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.
Primary endpoint
Measured: 90 days
Secondary outcomes (6)
Percent of Ellipsys Vascular Access procedures that successfully create an arteriovenous fistula (AVF) excluding Access Failures.
Device Success Rate
Measured: 12 months
The length of time until a patient is able to undergo 2-needle cannulation for dialysis OR access vessel has a diameter ≥ 6 mm and a mean flow rate of ≥ 600 ml/min if the patient is not undergoing dialysis.
Time to Functional Patency
Measured: 12 months
Percent of patients that require dialysis and sustain 3 consecutive 2-needle cannulations at the prescribed needle gauge and blood flow rate.
Dialysis Rate
Measured: 12 months
The number of surgical or endovascular interventions required to achieve or maintain Functional Patency.
Secondary Procedure Rate
Measured: 12 months
Number of patients with patency defined as an anastomosis that has flow whether it is being used for dialysis or not.
Arterio-venous fistula patency
Measured: 12 months
Length of time from initial access creation to achieve Functional Patency or to time of abandonment of AVF.
Cumulative patency
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Jul 2017
- Primary completion17 Apr 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454113
- Sponsor's protocol ID
- 1.0 ver 1.0 23 January 2017
- Status last verified
- Nov 2020
- First submitted
- 27 Feb 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ellipsys Vascular Access System Registry, Protocol 1.0. Version 1.0
- ClinicalTrials.gov ID
- NCT03454113
- Acronym / sponsor ID
- 1.0 ver 1.0 23 January 2017
- Conditions
- End-stage Renal Disease
- Keywords
- dialysis autogenous arterio-venous fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 5 Mar 2018 (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.
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an arteriovenous (AV) fistula via percutaneous access.
Detailed description
Ellipsys Vascular Access System Registry is a non-randomized, prospective, post-market, multi-center registry of the Ellipsys Vascular Access System in which up to 100 patients will be enrolled to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an AV fistula via percutaneous access. The primary performance endpoint is Clinical Success at the 90-day endpoint, where Clinical Success is defined as an access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with End-Stage Renal Disease or chronic kidney disease who provide written informed consent; who are currently require dialysis or it is anticipated will need dialysis within six months of enrollment; who meet all inclusion criteria and none of the exclusion criteria; and who are considered eligible for enrollment.
Key inclusion criteria (11 listed)
- Diagnosed with End-Stage Renal Disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment.
- Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment Adequate quality vein base on pre-operative assessment:
- Adequate quality artery base on pre-operative assessment:
- Radial artery-adjacent vein proximity < 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
- Patent palmar arch with adequate collateral perfusion as evidenced by Negative Allen's Test
Key exclusion criteria (12 listed)
- Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
- History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
- Evidence of clinically significant vascular disease at the radial artery/adjacent vein site on the ipsilateral side
- Systolic pressures < 100 mg Hg at the time of treatment
- Suspected or confirmed skin disease at the skin entry site
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 |
|---|---|---|
| Ellipsys Vascular AccessThe Ellipsys Vascular Access System comprises the Ellipsys Catheter, Ellipsys Crossing Needle and Ellipsys Power Controller. The Ellipsys Crossing Needle is used to facilitate access between the artery and the vein. The Ellipsys Catheter is placed percutaneously into the selected vein in close proximity to the selected artery. The Ellipsys Catheter is actuated at the selected anastomosis site, and the vein and artery are approximated. Once the vessels are in the appropriate relative positions the catheter is connected to the Ellipsys Power Controller to create the anastomosis after which the Ellipsys Catheter is removed, and the access site is closed using standard percutaneous closure techniques. | Device | – |
Primary outcome
The number of patients with a vascular access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.
Time frame: 90 days
Primary endpoint
6 secondary outcomes
Percent of Ellipsys Vascular Access procedures that successfully create an arteriovenous fistula (AVF) excluding Access Failures.
Time frame: 12 months
The length of time until a patient is able to undergo 2-needle cannulation for dialysis OR access vessel has a diameter ≥ 6 mm and a mean flow rate of ≥ 600 ml/min if the patient is not undergoing dialysis.
Time frame: 12 months
Percent of patients that require dialysis and sustain 3 consecutive 2-needle cannulations at the prescribed needle gauge and blood flow rate.
Time frame: 12 months
The number of surgical or endovascular interventions required to achieve or maintain Functional Patency.
Time frame: 12 months
Number of patients with patency defined as an anastomosis that has flow whether it is being used for dialysis or not.
Time frame: 12 months
Length of time from initial access creation to achieve Functional Patency or to time of abandonment of AVF.
Time frame: 12 months
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 8 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Medtronic Endovascular at 5 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 11 inclusion and 12 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The number of patients with a vascular access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound. (time frame: 90 days). 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 8 Feb 2021.