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

N/ACompletedNCT02119832

C. R. Bard17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease (CKD)

Interventions

Endovasccular AVF (EndoAVF)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Italian Hospital

Asunción, Paraguay

Outcomes

Primary Outcomes

Adverse Events

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

Time frame: 6 months

Secondary Outcomes

Access Functionality

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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