Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SelfWrap-treated | Experimental | Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SelfWrap Bioabsorbable Perivascular Wrap | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulative Patency | Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months | Through 6 months post-AVF creation |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assisted Primary Patency |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Ebner, MD | Sanatorio Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Italiano | Asunción | Paraguay |
Not provided
| Label | URL |
|---|---|
| VenoStent website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Number of Interventions | Through 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| D001164 | Arteriovenous Fistula |
| D014652 | Vascular Diseases |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D016157 | Vascular Fistula |
| D005402 | Fistula |
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided