SelfWrap-Assisted Arteriovenous Fistulas

Chronic Kidney Diseases Clinical Trial

— SW-AVF  

Official title:

Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05418816
• Other study ID #: PLN-030
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: VenoStent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years, male or female;

2. Subjects already receiving hemodialysis treatments that are ultimately referred for a new AVF, per current US KDOQI Clinical Practice Guidelines for Vascular Access updated in 2019 which recommend an AVF or arteriovenous graft (AVG) consistent with patient life-plan, overall goals of care, and anticipated duration of hemodialysis; if life expectancy > 1 year, recommend forearm AVF, forearm AVG, or upper arm AVF; if < 1 year, recommend forearm AVG/upper arm AVG; if urgent start, early cannulation AVG or central venous catheter (CVC);

3. Target cephalic vein inner diameter = 2.5 mm and target artery = 2.0 mm as measured via duplex ultrasound with a tourniquet applied;

4. For radial AVFs, a nonpathological modified Allen test;

5. Triphasic arterial flow and intact venous outflow;

6. A vascular access site being used for hemodialysis that is either positioned contralateral to the planned AVF creation surgery or located in the groin. If the catheter is positioned on the same side as the planned AVF, the catheter will be moved to the other arm prior to the AVF created surgery.

7. Participant is willing and able to comply with study requirements and sign an informed consent.

Exclusion Criteria:

1. Planned index procedure to revise or repair an existing fistula;

2. Twelve months or longer with a catheter, on the planned side of AVF creation; or if there has been any previously failed AVF and AVG on the planned side of AVF creation.

3. Significant (> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;

4. Known central venous stenosis > 50%;

5. Amputated limb;

6. Use of a peripherally-inserted central catheter (PICC) line;

7. Abnormal cardiac rhythm;

8. Known coagulation disorder;

9. Known or suspected active infection at the time of surgery;

10. Congestive heart failure NYHA class 4;

11. Prior steal on the side of surgery;

12. Enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint(s), or was previously enrolled in this study;

13. Life expectancy less than 12 months;

14. Patient expecting to undergo kidney transplant surgery within 12 months of enrollment;

15. Patient has a comorbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound data interpretation.

16. Unwillingness or inability to give consent and/or comply with the study follow up schedule.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Malformations
• Catheter Complications
• Catheter Dysfunction
• Chronic Kidney Diseases
• Chronic Kidney Failure
• Congenital Abnormalities
• End Stage Kidney Disease
• End Stage Renal Disease
• Fistula
• Hemodialysis Access Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure
• Renal Failure Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Urologic Diseases
• Vascular Diseases
• Vascular Fistula
• Vascular Malformations

Intervention

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.

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
VenoStent

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assisted Physiological Maturation	A created AVF with a proximal arterial flow rate = 500 mL/min and a vein inner diameter = 4.0 mm near the cannulation site, which required intervention(s) (e.g. angioplasty) to initially establish this flow rate and vein size	1, 2, 3, and 6 months post-AVF creation
Other	Assisted Primary Patency	Proportion of participants with a created AVF that is not abandoned nor occluded and is free from access thrombosis, through 1, 2, 3, 6, and 12 months	1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
Other	Time-to-Cannulation (or Cumulative Incidence)	The time from AVF creation to the first two-needle hemodialysis through the newly-created AVF, as reported by the clinical research associate or site-designated clinician	Through 12 months
Other	Time-to-Maturation (Functional Maturation)	The duration of time from AVF creation to the first date that the AVF is able to provide prescribed dialysis consistently with two needles for more than two thirds of dialysis sessions within 4 consecutive weeks, as reported by the CRA or site-designated clinician	Through 12 months
Other	Functional Primary Patency	Proportion of participants with a created AVF that is free from thrombosis as well as any intervention required to facilitate, maintain, or reestablish patency (e.g. angioplasty), from the first date that it is able to provide prescribed dialysis consistently with two needles for more than two thirds of dialysis sessions within 4 consecutive weeks (i.e. mature AVF) as reported by the CRA or site-designated clinician, at 2, 3, 6, and 12 months	2, 3, 6, 12, 18, and 24 months
Other	Functional Cumulative Patency	Proportion of participants with a created AVF that is not abandoned or occluded, from the first date that it is able to provide prescribed dialysis consistently with two needles for more than two thirds of dialysis sessions within 4 consecutive weeks as reported by the CRA or site-designated clinician, at 2, 3, 6, and 12 months	2, 3, 6, 12, 18, and 24 months
Primary	Primary Patency	Proportion of participants with a created AVF that is not abandoned nor occluded and is free from access thrombosis as well as any intervention required to facilitate, maintain, or reestablish patency (e.g. angioplasty), through 6 months	Through 6 months post-AVF creation
Primary	Cumulative Patency	Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months	Through 6 months post-AVF creation
Primary	Freedom from Device-Related Safety Events	Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations	Through 6 months post-AVF creation
Secondary	Primary Patency	Proportion of participants with a created AVF that is not abandoned nor occluded and is free from access thrombosis as well as any intervention required to facilitate, maintain, or reestablish patency (e.g. angioplasty), through 1, 2, 3, and 12 months	Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Secondary	Cumulative Patency	Proportion of participants with a created AVF that is not abandoned or occluded, through 1, 2, 3, and 12 months	Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Secondary	Number of Interventions		Through 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
Secondary	Unassisted Physiological Maturation	A created AVF with a proximal arterial flow rate = 500 mL/min and a vein inner diameter = 4.0 mm near the cannulation site, in absence of intervention(s) to initially establish this flow rate and vein size	1, 2, 3, and 6 months post-AVF creation
Secondary	Freedom from Device-Related Safety Events	Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations	Through 1, 2, 3, 12, 18, and 24 months post-AVF creation

External Links

•   VenoStent website