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Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)

Hemodialysis Access Failure Clinical Trial

Official title:
A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects With Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.

Clinical Trial Description

AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03734679
Study type Interventional
Source SurModics, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date December 5, 2018
Completion date December 2024
View Details
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