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

C. R. Bard

Status: Completed

Conditions: Chronic Kidney Disease (CKD)

Treatments: Device: Endovasccular AVF (EndoAVF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02119832

FLEX-1-002-IR

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Endovascular AVF (EndoAVF)

Experimental group

Description:

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

Treatment:

Device: Endovasccular AVF (EndoAVF)