Renal Insufficiency, ChronicNCT02816398
Catheter System Feasibility Clinical Trial
A study testing Percutaneous creation of an arteriovenous fistula in people with Renal Insufficiency, Chronic, run by Medtronic Endovascular.
Trial summary
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Percutaneous creation of an arteriovenous fistula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 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 deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
- Patients diagnosed with chronic kidney disease classification stage IV or V
- Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
- Adequate quality radial artery >= 2 mm based on pre-operative assessment
- Adequate collateral arterial perfusion
- Radial artery-adjacent vein proximity < = 1.5 mm
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- Able to provide informed consent
- Able to travel to institution for follow up examination
- Able to intraoperatively place an .014" guidewire in artery
Who cannot join
- Suspected skin disease
- Immunocompromised patients (e.g. HIV positive)
- Edema of extremities
- Current diagnosis of carcinoma
- Pregnancy or currently breast feeding
- Diagnosed hypercoaguable state
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- Active infection
- Evidence of vascular disease at target site
- Pre-existing vascular disease that could confound study results
- Vessel tortuosity or spasm preventing placement of .014" guidewire
About this study
Official title: Vessel-Select Catheter System Feasibility Clinical Trial
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Percutaneous creation of an arteriovenous fistula
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous creation of an arteriovenous fistulaDevice
Use of catheter system for percutaneous creation of an arteriovenous fistula
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Receives: Device: Percutaneous creation of an arteriovenous fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sufficient Patency for Clinical Access
Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
Measured: 6 weeks
Number of Patients Achieving Dialysis Access
Arteriovenous fistula is mature and patient has started dialysis using the fistula
Measured: 6 weeks
Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis
Measured: 3 months
Secondary outcomes (1)
Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionJan 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 Renal Insufficiency, ChronicStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816398
- Sponsor's protocol ID
- 01-0012-01
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2016
- Last updated
- 5 Feb 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vessel-Select Catheter System Feasibility Clinical Trial
- ClinicalTrials.gov ID
- NCT02816398
- Acronym / sponsor ID
- 01-0012-01
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Percutaneous creation of an arteriovenous fistulaInterventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
- Patients diagnosed with chronic kidney disease classification stage IV or V
- Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
- Adequate quality radial artery >= 2 mm based on pre-operative assessment
- Adequate collateral arterial perfusion
Key exclusion criteria (10 listed)
- Suspected skin disease
- Immunocompromised patients (e.g. HIV positive)
- Edema of extremities
- Current diagnosis of carcinoma
- Pregnancy or currently breast feeding
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 |
|---|---|---|
| Percutaneous creation of an arteriovenous fistulaUse of catheter system for percutaneous creation of an arteriovenous fistula | Device | Treatment |
Primary outcome
Number of Participants With Sufficient Patency for Clinical Access
Time frame: 6 weeks
Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
Number of Patients Achieving Dialysis Access
Time frame: 6 weeks
Arteriovenous fistula is mature and patient has started dialysis using the fistula
Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
Time frame: 3 months
Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis
1 secondary outcome
Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous creation of an arteriovenous fistula in people with Renal Insufficiency, Chronic, run by Medtronic Endovascular.
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 9 inclusion and 10 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 12 Aug 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?
Number of Participants With Sufficient Patency for Clinical Access (time frame: 6 weeks). The study lists 3 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 5 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.