NCT02036671

Brief Summary

The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
3 countries

9 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

January 10, 2014

Last Update Submit

November 25, 2025

Conditions

Chronic Kidney Disease

Keywords

Arteriovenous fistulaFistulaChronic kidney diseasePercutaneousKidney DiseaseKidney Failure, ChronicUrologic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyCKDhemodialysis

Outcome Measures

Primary Outcomes (1)

  • Primary Efficacy Endpoint:

    The percentage of patients with fistula maturation/usability defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR patient was dialyzed using 2 needles.

    within 3 months

Secondary Outcomes (5)

  • Safety Endpoint

    within 3 months

  • EndoAVF-related Re-intervention Rate

    3, 6 and 12 months

  • Primary Patency

    3, 6 and 12 months

  • Cumulative Patency

    3, 6 and 12 months

  • Functional Usability

    4 weeks post procedure, up to 12 months

Study Arms (1)

EndoAVF

EXPERIMENTAL

The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

Interventions

The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular accessDEVICE
EndoAVF

Eligibility Criteria

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

You may qualify if:

  • Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
  • Adult (age \>18 years old).
  • Established, non-reversible kidney failure requiring hemodialysis.
  • Written informed consent obtained.

You may not qualify if:

  • Functioning surgical access in the planned treatment arm.
  • Pregnant women.
  • New York Heart Association (NYHA) class III or IV heart failure.
  • Allergy to contrast dye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

QE II Health Sciences Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

The Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

CHUM, Notre-Dame Hospital

Montreal, Quebec, H2L 4M1, Canada

Location

Auckland City Hospital

Grafton, 1142, New Zealand

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicArteriovenous FistulaFistulaKidney DiseasesKidney Failure, ChronicUrologic DiseasesRenal Insufficiency

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, Anatomical

Study Officials

  • Charmaine Lok, MD, MSC, FRCPC

    The Toronto General Hospital

    PRINCIPAL INVESTIGATOR

  • Dheeraj Rajan, MD, BSc, FRCPC, FSIR

    The Toronto General Hospital

    PRINCIPAL INVESTIGATOR

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

January 10, 2014

First Posted

January 15, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

October 1, 2016

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations

NZ(1)CA(6)AU(2)