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Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)

Primary Purpose

End Stage Renal Disease

Status
Recruiting
Phase
Phase 1
Locations
Panama
Study Type
Interventional
Intervention
Arteriovenous conduit implant
Sponsored by
Vascudyne, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring hemodialysis, arteriovenous access

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with end stage kidney disease (ESKD) who are poor candidates for creation of a simple autogenous AV fistula (without requiring transposition) and therefore need placement of an AV access in the upper extremity to start or maintain hemodialysis therapy.
  2. Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
  3. Patients between 18 and 75 years old, inclusive.
  4. Verify adequate arterial flow and venous runoff using duplex ultrasound and venogram. Ensure outflow vein is at least 5 mm in diameter with good compliance.
  5. Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to implant.
  6. Other hematological and biochemical parameters within a range consistent with ESKD and acceptable for the administration of regional or general anesthesia prior to implant.
  7. Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or INR ≤ 1.5 prior to implant.
  8. Life expectancy of at least 1 year.
  9. Negative COVID-19 test within 3 days prior and negative for symptoms within 14 days prior to implant.
  10. Female subjects must be either:

    1. Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening)
    2. Or, of childbearing potential, in which case:

    i. Must have a negative urine blood pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study:

1. Established use of oral, injectable or implanted hormonal methods of contraception 2. Placement of an intrauterine device or intrauterine system 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository 11. Able to communicate meaningfully with investigative staff and able to comply with entire study procedures.

12. Willing and competent to give written informed consent

Exclusion Criteria:

  1. History or evidence of severe cardiac disease (NYHA Functional Class III or IV); myocardial infarction within six months prior to study entry; ventricular tachyarrhythmias requiring continuing treatment; unstable angina; or ejection fraction < 50%.
  2. Uncontrolled or poorly controlled diabetes defined as A1C > 8; hospitalization for poor glucose control within the previous 6 months.
  3. History or evidence of severe peripheral vascular disease in the upper limbs
  4. Known or suspected central vein obstruction on the side of planned study conduit implantation. Avoid patients with current subclavian catheters or leads on the side of the study conduit implant. If the patient had previous subclavian catheters or leads on the implant side, verify adequate runoff with a venogram.
  5. Documented hypercoagulable state or history of thromboembolic events or history of repeated venous catheter clotting.
  6. Known Positive COVID 19 test result or known exposure to COVID 19 in past 3 months.
  7. Known active infection including dental infection, osteomyelitis and other conditions which could present a local or systemic risk of infection.
  8. Bleeding diathesis.
  9. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet therapy. History of heparin-induced thrombocytopenia.
  10. Immunodeficiency including AIDS / HIV or active autoimmune disease, or on immunosuppressant therapy.
  11. Autoimmune nephropathy
  12. Previous PTFE graft in the operative limb unless the TRUE AVC can be placed more proximally than the previous failed graft.
  13. More than 1 failed PTFE graft in the operative limb.
  14. Patients receiving an AV access which crosses the elbow.
  15. Patients receiving a lower extremity AV access.
  16. Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in a clinical trial of an investigational product.

Sites / Locations

  • Centro de Asistencia RenalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational

Arm Description

Study subjects implanted with a TRUE AVC as an arteriovenous conduit for hemodialysis

Outcomes

Primary Outcome Measures

Adverse Event Incidence
incidence of clinically significant aneurysm, anastomotic bleeding, study conduit or anastomotic rupture, study conduit infection, and implant site irritation, inflammation, or infection
Patency
Kaplan-Meier freedom from loss of primary patency, primary assisted patency, and secondary patency.

Secondary Outcome Measures

Change in antigen sensitivity
Assess changes in anti-HLA sensitivity in each implant recipient, from baseline through four weeks, using panel reactive antibody (PRA) test
Rate of Interventions
Rate of interventions needed to maintain patency

Full Information

First Posted
September 27, 2022
Last Updated
October 27, 2022
Sponsor
Vascudyne, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05567757
Brief Title
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
Official Title
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascudyne, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.
Detailed Description
Twenty (20) patients with end-stage kidney disease (ESKD), who are poor candidates for an autogenous fistula creation and either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation will be implanted with a TRUE AVC as an arteriovenous conduit in the upper extremity. Study subjects will be evaluated for implant safety and patency at 26 weeks. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
hemodialysis, arteriovenous access

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational
Arm Type
Experimental
Arm Description
Study subjects implanted with a TRUE AVC as an arteriovenous conduit for hemodialysis
Intervention Type
Biological
Intervention Name(s)
Arteriovenous conduit implant
Intervention Description
Study subjects will be implanted with an arteriovenous shunt for hemodialysis access in the upper extremity
Primary Outcome Measure Information:
Title
Adverse Event Incidence
Description
incidence of clinically significant aneurysm, anastomotic bleeding, study conduit or anastomotic rupture, study conduit infection, and implant site irritation, inflammation, or infection
Time Frame
through 26 weeks post implant
Title
Patency
Description
Kaplan-Meier freedom from loss of primary patency, primary assisted patency, and secondary patency.
Time Frame
through 26 weeks post implant
Secondary Outcome Measure Information:
Title
Change in antigen sensitivity
Description
Assess changes in anti-HLA sensitivity in each implant recipient, from baseline through four weeks, using panel reactive antibody (PRA) test
Time Frame
baseline through 4 weeks
Title
Rate of Interventions
Description
Rate of interventions needed to maintain patency
Time Frame
26 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
self-report of gender identity
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with end stage kidney disease (ESKD) who are poor candidates for creation of a simple autogenous AV fistula (without requiring transposition) and therefore need placement of an AV access in the upper extremity to start or maintain hemodialysis therapy. Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation. Patients between 18 and 75 years old, inclusive. Verify adequate arterial flow and venous runoff using duplex ultrasound and venogram. Ensure outflow vein is at least 5 mm in diameter with good compliance. Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to implant. Other hematological and biochemical parameters within a range consistent with ESKD and acceptable for the administration of regional or general anesthesia prior to implant. Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤2x upper limit of normal or INR ≤ 1.5 prior to implant. Life expectancy of at least 1 year. Negative COVID-19 test within 3 days prior and negative for symptoms within 14 days prior to implant. Female subjects must be either: Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening) Or, of childbearing potential, in which case: i. Must have a negative urine blood pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study: 1. Established use of oral, injectable or implanted hormonal methods of contraception 2. Placement of an intrauterine device or intrauterine system 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository 11. Able to communicate meaningfully with investigative staff and able to comply with entire study procedures. 12. Willing and competent to give written informed consent Exclusion Criteria: History or evidence of severe cardiac disease (NYHA Functional Class III or IV); myocardial infarction within six months prior to study entry; ventricular tachyarrhythmias requiring continuing treatment; unstable angina; or ejection fraction < 50%. Uncontrolled or poorly controlled diabetes defined as A1C > 8; hospitalization for poor glucose control within the previous 6 months. History or evidence of severe peripheral vascular disease in the upper limbs Known or suspected central vein obstruction on the side of planned study conduit implantation. Avoid patients with current subclavian catheters or leads on the side of the study conduit implant. If the patient had previous subclavian catheters or leads on the implant side, verify adequate runoff with a venogram. Documented hypercoagulable state or history of thromboembolic events or history of repeated venous catheter clotting. Known Positive COVID 19 test result or known exposure to COVID 19 in past 3 months. Known active infection including dental infection, osteomyelitis and other conditions which could present a local or systemic risk of infection. Bleeding diathesis. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet therapy. History of heparin-induced thrombocytopenia. Immunodeficiency including AIDS / HIV or active autoimmune disease, or on immunosuppressant therapy. Autoimmune nephropathy Previous PTFE graft in the operative limb unless the TRUE AVC can be placed more proximally than the previous failed graft. More than 1 failed PTFE graft in the operative limb. Patients receiving an AV access which crosses the elbow. Patients receiving a lower extremity AV access. Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in a clinical trial of an investigational product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Stenoien
Phone
+7632031032
Email
mstenoien@vascudyne.com
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Murphy
Phone
+7636454609
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernesto Alvarado, MD
Organizational Affiliation
Centro de Asistencia Renal, Río Hato, Coclé, Panamá
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Asistencia Renal
City
Río Hato
State/Province
Coclé
Country
Panama
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesto Alvarado, MD

12. IPD Sharing Statement

Learn more about this trial

Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)

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