At a glance
ClinicalIndex Comparison RecordN/ACompleted· 12 enrolled
Drug / intervention
SurVeil Drug Coated Balloondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating SurVeil Drug Coated Balloon for Hemodialysis Access Failure. Completed, enrolled 12 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemodialysis Access Failure
CountriesAustralia, New Zealand
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartDec 2018
Primary CompletionFeb 2020
Study CompletionJul 2024
TodayJul 2026
First PostedNov 8, 2018
Enrollment StartDec 5, 2018
Primary CompletionFeb 19, 2020
Study CompletionJul 24, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.6 years ago
Interventions
SurVeil Drug Coated Balloondevice
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.