Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

Conditions

Arteriovenous Graft, End Stage Renal Disease, Hemolysis

Keywords

Hemodialysis, Arteriovenous, Graft, polytetrafluoroethylene, Bovine

Brief summary

The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.

Detailed description

Arteriovenous grafts (AVG) remain reliable substitutes for permanent hemodialysis access in scenarios that preclude the placement of arteriovenous fistulae. There is scarcity of evidence to support the current preference of synthetic conduits over biologic grafts in clinical practice. Advances in the design of AVG's warrant contemporary comparisons between synthetic and biologic AVG options. This is especially important as biologic conduits may confer an advantage by virtue of their inherent similarity to the native human vasculature. The overall goal of this project is to compare one and two year patency (functional, primary, primary assisted and secondary), complication rates and re-intervention rates between BCA and standard ePTFE grafts. The investigators hypothesize that vascular patient who will receive the BCA graft will have improved patency as well as lower complication and re-intervention rates compared to the standard ePTFE graft.

Related papers

No related papers found yet.

Interventions

DEVICEExpanded polytetrafluoroethylene Graft

Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.

DEVICEBovine Carotid Artery Graft

Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

The study will not be blinded because patient side blinding is expected to have minimal to no effect, while physician side blinding is impractical; and difficult to achieve due to the primary surgeon being the one usually who follows up on any intervention or treatment.

Intervention model description

Patients will undergo surgery as per standard of care and receive the randomized graft in compliance to National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Arteriovenous graft creation. Surgeries will be elective in nature. The grafts will be placed either in the arm (brachial artery-axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) based on anatomic suitability

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

No

Inclusion criteria

* Patients at least 18 years of age * Have End Stage Renal Disease and are undergoing Arterio-Venous-Graft surgery * Not Eligible to receive an Arterio-Venous-Fistula * Provided written informed consent * Agreed to return for all required clinical follow up for the study

Exclusion criteria

* Eligible to receive an Arterio-Venous-Fistula * Known allergic reaction or history of intolerance to any ePTFE or BCA components * Local infection at AVG placement site at the time of surgery * Patients with a bleeding disorder or who refuse blood transfusion * Patients with an active malignancy * Life expectancy less than 1 year * Pregnant women or those planning on becoming pregnant for the duration of the study

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients With Functional Patency	One year after Graft Placement	Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
Percentage of Patients With Primary Graft Patency	One year after Graft Placement	Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Percentage of Patients With Primary-Assisted Graft Patency	One year after Graft Placement	Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Percentage of Patients With Secondary Graft Patency	One year after Graft Placement	Secondary patency is defined as the interval from graft placement to graft failure.

Secondary

Measure	Time frame	Description
Incidence of Pseudoaneurysms Formation at the Access Site	At 6 months after Graft Placement	—
Percentage of Patients With Surgical Site Infection	At 6 months after Graft Placement	The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Steal Syndrome	At 6 months after Graft Placement	Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft	At 6 months after Graft Placement	At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention

Countries

United States

Participant flow

Participants by arm

Arm	Count
Expanded Polytetrafluoroethylene (ePTFE) The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t	4
Bovine Carotid Artery Graft The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant. Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.	6
Total	10

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Physician Decision	4	6

Baseline characteristics

Characteristic	Bovine Carotid Artery Graft	Total	Expanded Polytetrafluoroethylene (ePTFE)
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	3 Participants	4 Participants	1 Participants
Age, Categorical Between 18 and 65 years	3 Participants	6 Participants	3 Participants
Age, Continuous	67.2 years	65.7 years	63.5 years
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	6 Participants	10 Participants	4 Participants
Sex: Female, Male Female	3 Participants	7 Participants	4 Participants
Sex: Female, Male Male	3 Participants	3 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Percentage of Patients With Functional Patency

Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)

Time frame: One year after Graft Placement