End Stage Renal DiseaseNCT02363972
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A study testing Ellipsys Vascular Access Catheter in people with End Stage Renal Disease and AV Fistula, run by Medtronic Endovascular at 5 sites in United States.
Trial summary
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease, AV Fistula, Fistula
- What is being tested?
- Ellipsys Vascular Access Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Feb 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible for enrollment into the study if they met the following criteria:
- Patients ≥ 18 years of age and ≤ 80 years of age
- Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
- Life expectancy of at least one year, per the investigator's opinion
- 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
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- Adequate quality vein based on pre-operative assessment
- Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site
- Confirmed clinically significant outflow
- Adequate quality radial artery based on pre-operative assessment
- Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site
- Adequate collateral arterial perfusion
- Patent palmar arch
- Negative Allen's Test for ulnar artery insufficiency
- No clinical evidence of subclavian artery stenosis on the ipsilateral side.
- Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
- Patient was able to provide written informed consent
- Able to travel to enrolling institution for follow-up examinations
- Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see exclusion criteria 15)
Who cannot join
- Patients were excluded if any of the following was true:
- Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
- a. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site
- History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
- Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side
- Pre-existing vascular disease that could confound the study results
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- Systolic pressures < 100 mm Hg at the time of screening
- Suspected or confirmed skin disease at the skin entry site
- Immunocompromised patients (e.g. HIV positive)
- 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
- Current diagnosis of carcinoma (defined as in remission < 1 year)
- Pregnant or currently breast feeding
- Known bleeding diathesis or coagulation disorder
- Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
- Patients with acute or active infection
- Scheduled kidney transplant within 6 months of enrollment
- Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
- History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
- Patient required creation of an arteriovenous fistula distal to the wrist
- Patient required nerve block requiring immobilization of the arm
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Richmond Vascular Center
North Chesterfield, Virginia, 23236
Dallas Nephrology Associates
Plano, Texas, 75093
San Antonio Kidney Disease Center
San Antonio, Texas, 78016
BNMG San Diego Vascular Access Center
San Diego, California, 92115
Southwest Vascular Center
Tempe, Arizona, 85281
About this study
Official title: Ellipsys Vascular Access Catheter System Clinical Trial
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Being tested
- Ellipsys Vascular Access Catheter
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellipsys Vascular Access CatheterDevice
A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
| Study group | Role | What they receive |
|---|---|---|
| Ellipsys Vascular Access Catheter | Experimental | ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. Receives: Device: Ellipsys Vascular Access Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maturation Success Rate at 90 Days
Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.
Measured: 90 days
Number of Participants With Device-related Serious Adverse Events
The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.
Measured: 90 days
Secondary outcomes (9)
Percent of Participants With Access Systems That Successfully Created an AVF
Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment
Measured: 90 days
Percent of Access Sites With Clinical Patency at Discharge
Percent of access sites that demonstrated physical exam patency through clinic discharge
Measured: 90 days
Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days
Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation
Measured: 90 days
Percent of Access Sites That Achieved or Maintained Maturation at 90 Days
Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency.
Measured: 90 days
Percent of Access Sites That Achieved Maturation Without Intervention
Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation
Measured: 90 days
Percent of Access Sites That Were Patent Following Intervention
Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency
Measured: 90 days
Percent of Access Sites That Achieved Patency Without Intervention
Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site
Measured: 90 days
Intervention Rate
Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site
Measured: 90 days
Transposition Rate
Percent of subjects who required one or more surgical transpositions performed to facilitate needle access
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study start10 Feb 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Hull, MD, Principal investigator, Richmond Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363972
- Sponsor's protocol ID
- 01-0014-01
- Status last verified
- Nov 2021
- First submitted
- 6 Feb 2015
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ellipsys Vascular Access Catheter System Clinical Trial
- ClinicalTrials.gov ID
- NCT02363972
- Acronym / sponsor ID
- 01-0014-01
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 9 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ellipsys Vascular Access Catheter | Experimental | Device: Ellipsys Vascular Access CatheterESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients ≥ 18 years of age and ≤ 80 years of age
- Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
- Life expectancy of at least one year, per the investigator's opinion
- 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
Key exclusion criteria (22 listed)
- Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
- a. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site
- History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
- Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side
- Pre-existing vascular disease that could confound the study results
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 Access CatheterA one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae. | Device | Ellipsys Vascular Access Catheter |
Primary outcome
Maturation Success Rate at 90 Days
Time frame: 90 days
Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.
Number of Participants With Device-related Serious Adverse Events
Time frame: 90 days
The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.
9 secondary outcomes
Percent of Participants With Access Systems That Successfully Created an AVF
Time frame: 90 days
Percent of Access Sites With Clinical Patency at Discharge
Time frame: 90 days
Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days
Time frame: 90 days
Percent of Access Sites That Achieved or Maintained Maturation at 90 Days
Time frame: 90 days
Percent of Access Sites That Achieved Maturation Without Intervention
Time frame: 90 days
Percent of Access Sites That Were Patent Following Intervention
Time frame: 90 days
Percent of Access Sites That Achieved Patency Without Intervention
Time frame: 90 days
Intervention Rate
Time frame: 90 days
Transposition Rate
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Hull, MD principal investigator
Richmond Vascular Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ellipsys Vascular Access Catheter in people with End Stage Renal Disease and AV Fistula, run by Medtronic Endovascular at 5 sites in United States.
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 19 inclusion and 22 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 Nov 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maturation Success Rate at 90 Days (time frame: 90 days). 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 Nov 2021.