Catheter System Feasibility Clinical Trial

February 3, 2021 updated by: Medtronic Endovascular

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Able to provide informed consent
  • Able to travel to institution for follow up examination
  • Able to intraoperatively place an .014" guidewire in artery

Exclusion Criteria:

  • Suspected skin disease
  • Immunocompromised patients (e.g. HIV positive)
  • Edema of extremities
  • Current diagnosis of carcinoma
  • Pregnancy or currently breast feeding
  • Diagnosed hypercoaguable state
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula
Device: Percutaneous creation of an arteriovenous fistula
Use of catheter system for percutaneous creation of an arteriovenous fistula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
Number of Patients Achieving Dialysis Access
Time Frame: 6 weeks
Arteriovenous fistula is mature and patient has started dialysis using the fistula
6 weeks
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
Time Frame: 12 weeks
The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Collaborators

Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-0012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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