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Completed

NCT Number: NCT02119832

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.

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Key information

Conditions

Chronic Kidney Disease (CKD) Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Italian Hospital

Asunción, 1001-1925, Paraguay

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
  • Adult (age >18 years old).
  • Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
  • Written informed consent obtained

Treatment and study plan

Endovasccular AVF (EndoAVF)

Device

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

Other names: FLEX

Primary outcomes

  1. Adverse Events

    Time frame: 6 months

    The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.

Secondary outcomes

  1. Access Functionality

    Time frame: 6 months

    The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2014
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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