Clinical trial NCT05418816: SelfWrap-Assisted Arteriovenous Fistulas
Official title: Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Keywords: Dialysis
Hemodialysis
Chronic Kidney Disease
End Stage Renal Disease
Vascular Surgery
Vascular Access
Arteriovenous Fistula
AVF
Nephrology
Bioabsorbable
Perivascular Wrap
External Support
Lead sponsor: VenoStent
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Patency
timeFrame: Through 6 months post-AVF creation
measure: Cumulative Patency
timeFrame: Through 6 months post-AVF creation
measure: Freedom from Device-Related Safety Events
timeFrame: Through 6 months post-AVF creation
Secondary outcomes:
measure: Primary Patency
timeFrame: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
measure: Cumulative Patency
timeFrame: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
measure: Number of Interventions
timeFrame: Through 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
measure: Unassisted Physiological Maturation
timeFrame: 1, 2, 3, and 6 months post-AVF creation
measure: Freedom from Device-Related Safety Events
timeFrame: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Other outcomes:
measure: Assisted Physiological Maturation
timeFrame: 1, 2, 3, and 6 months post-AVF creation
measure: Assisted Primary Patency
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
measure: Time-to-Cannulation (or Cumulative Incidence)
timeFrame: Through 12 months
measure: Time-to-Maturation (Functional Maturation)
timeFrame: Through 12 months
measure: Functional Primary Patency
timeFrame: 2, 3, 6, 12, 18, and 24 months
measure: Functional Cumulative Patency
timeFrame: 2, 3, 6, 12, 18, and 24 months
Locations:
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: Sanatorio Italiano
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References: