NCT02816398

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

August 12, 2020

Completed
Last Updated

February 5, 2021

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

June 23, 2016

Results QC Date

June 25, 2018

Last Update Submit

February 3, 2021

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (3)

  • 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.

    6 weeks

  • Number of Patients Achieving Dialysis Access

    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

    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 Outcomes (1)

  • Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access

    12 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula

Device: Percutaneous creation of an arteriovenous fistula

Interventions

Percutaneous creation of an arteriovenous fistulaDEVICE

Use of catheter system for percutaneous creation of an arteriovenous fistula

Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gene Reu
Organization
Avenu Medical - Sponsor
greu@avenumedical.com
949 276 2483

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 28, 2016

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

February 5, 2021

Results First Posted

August 12, 2020

Record last verified: 2016-06