Back to resultsSelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)
Primary Purpose
Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease
Status
Active
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
SelfWrap Bioabsorbable Perivascular Wrap
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Dialysis, Hemodialysis, Chronic Kidney Disease, End Stage Renal Disease, Vascular Surgery, Vascular Access, Arteriovenous Fistula, AVF, Nephrology, Bioabsorbable, Perivascular Wrap, External Support
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years, male or female;
- 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);
- Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied;
- For radial AVFs, a nonpathological modified Allen test;
- Triphasic arterial flow and intact venous outflow;
- 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.
- Participant is willing and able to comply with study requirements and sign an informed consent.
Exclusion Criteria:
- Planned index procedure to revise or repair an existing fistula;
- 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.
- Significant (> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;
- Known central venous stenosis > 50%;
- Amputated limb;
- Use of a peripherally-inserted central catheter (PICC) line;
- Abnormal cardiac rhythm;
- Known coagulation disorder;
- Known or suspected active infection at the time of surgery;
- Congestive heart failure NYHA class 4;
- Prior steal on the side of surgery;
- Enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint(s), or was previously enrolled in this study;
- Life expectancy less than 12 months;
- Patient expecting to undergo kidney transplant surgery within 12 months of enrollment;
- 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.
- Unwillingness or inability to give consent and/or comply with the study follow up schedule.
Sites / Locations
- Sanatorio Italiano
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SelfWrap-treated
Arm Description
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
Outcomes
Primary Outcome Measures
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
Cumulative Patency
Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months
Freedom from Device-Related Safety Events
Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations
Secondary Outcome Measures
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
Cumulative Patency
Proportion of participants with a created AVF that is not abandoned or occluded, through 1, 2, 3, and 12 months
Number of Interventions
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
Freedom from Device-Related Safety Events
Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05418816
Brief Title
SelfWrap-Assisted Arteriovenous Fistulas
Acronym
SW-AVF
Official Title
Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VenoStent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SelfWrap-treated
Arm Type
Experimental
Arm Description
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
Intervention Type
Device
Intervention Name(s)
SelfWrap Bioabsorbable Perivascular Wrap
Other Intervention Name(s)
SelfWrap
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Patency
Description
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
Time Frame
Through 6 months post-AVF creation
Title
Cumulative Patency
Description
Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months
Time Frame
Through 6 months post-AVF creation
Title
Freedom from Device-Related Safety Events
Description
Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations
Time Frame
Through 6 months post-AVF creation
Secondary Outcome Measure Information:
Title
Primary Patency
Description
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
Time Frame
Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Title
Cumulative Patency
Description
Proportion of participants with a created AVF that is not abandoned or occluded, through 1, 2, 3, and 12 months
Time Frame
Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Title
Number of Interventions
Time Frame
Through 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
Title
Unassisted Physiological Maturation
Description
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
Time Frame
1, 2, 3, and 6 months post-AVF creation
Title
Freedom from Device-Related Safety Events
Description
Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations
Time Frame
Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Other Pre-specified Outcome Measures:
Title
Assisted Physiological Maturation
Description
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
Time Frame
1, 2, 3, and 6 months post-AVF creation
Title
Assisted Primary Patency
Description
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
Time Frame
1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
Title
Time-to-Cannulation (or Cumulative Incidence)
Description
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
Time Frame
Through 12 months
Title
Time-to-Maturation (Functional Maturation)
Description
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
Time Frame
Through 12 months
Title
Functional Primary Patency
Description
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
Time Frame
2, 3, 6, 12, 18, and 24 months
Title
Functional Cumulative Patency
Description
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
Time Frame
2, 3, 6, 12, 18, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years, male or female;
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);
Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied;
For radial AVFs, a nonpathological modified Allen test;
Triphasic arterial flow and intact venous outflow;
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.
Participant is willing and able to comply with study requirements and sign an informed consent.
Exclusion Criteria:
Planned index procedure to revise or repair an existing fistula;
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.
Significant (> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;
Known central venous stenosis > 50%;
Amputated limb;
Use of a peripherally-inserted central catheter (PICC) line;
Abnormal cardiac rhythm;
Known coagulation disorder;
Known or suspected active infection at the time of surgery;
Congestive heart failure NYHA class 4;
Prior steal on the side of surgery;
Enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint(s), or was previously enrolled in this study;
Life expectancy less than 12 months;
Patient expecting to undergo kidney transplant surgery within 12 months of enrollment;
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.
Unwillingness or inability to give consent and/or comply with the study follow up schedule.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Ebner, MD
Organizational Affiliation
Sanatorio Italiano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanatorio Italiano
City
Asunción
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.venostent.com
Description
VenoStent website
Learn more about this trial
SelfWrap-Assisted Arteriovenous Fistulas
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