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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02119832
• Date of registration: 17/04/2014
• Prospective Registration: No
• Primary sponsor: TVA Medical Inc.
• Public title: A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
• Scientific title: A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction
• Date of first enrolment: April 2013
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02119832
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Paraguay

Contacts

• Name: Adrian Ebner, MD
• Affiliation: Italian Hosptial, Asuncion, Paraguay

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease (CKD)

Intervention(s)

Device: Endovasccular AVF (EndoAVF)

Primary Outcome(s)

Adverse Events [Time Frame: 6 months]

Secondary Outcome(s)

Access Functionality [Time Frame: 6 months]

Secondary ID(s)

FLEX-1-002-IR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors