Trials / Completed
CompletedNCT03734679
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- SurModics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SurVeil Drug Coated Balloon | Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. |
Timeline
- Start date
- 2018-12-05
- Primary completion
- 2020-02-19
- Completion
- 2024-07-24
- First posted
- 2018-11-08
- Last updated
- 2025-02-06
- Results posted
- 2022-09-29
Locations
2 sites across 2 countries: Australia, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03734679. Inclusion in this directory is not an endorsement.