Trials / Active Not Recruiting
Active Not RecruitingNCT05418816
SelfWrap-Assisted Arteriovenous Fistulas
Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- VenoStent · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).
Conditions
- Chronic Kidney Diseases
- Chronic Kidney Failure
- End Stage Renal Disease
- End Stage Kidney Disease
- Arteriovenous Fistula
- Hemodialysis Access Failure
- Catheter Complications
- Catheter Dysfunction
- Vascular Diseases
- Arteriovenous Malformations
- Vascular Malformations
- Vascular Fistula
- Fistula
- Renal Insufficiency
- Renal Failure
- Renal Failure Chronic
- Urologic Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SelfWrap Bioabsorbable Perivascular Wrap | SelfWrap is applied during the normal arteriovenous fistula (AVF) creation procedure. It provides mechanical support to the vein and induces outward remodeling to improve maturation and patency of AVFs. |
Timeline
- Start date
- 2021-06-14
- Primary completion
- 2022-02-23
- Completion
- 2026-09-01
- First posted
- 2022-06-14
- Last updated
- 2025-04-01
Locations
1 site across 1 country: Paraguay
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05418816. Inclusion in this directory is not an endorsement.