The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
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.
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.
Johns Hopkins University
Baltimore, Maryland, United States
Percentage of Patients With Primary Graft Patency
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Time frame: One year after Graft Placement
Percentage of Patients With Primary-Assisted Graft Patency
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Time frame: One year after Graft Placement
Percentage of Patients With Secondary Graft Patency
Secondary patency is defined as the interval from graft placement to graft failure.
Time frame: One year after Graft Placement
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
Percentage of Patients With Primary Graft Patency
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Time frame: Two years after Graft Placement
Percentage of Patients With Primary-Assisted Graft Patency
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Time frame: Two years after Graft Placement
Percentage of Patients With Secondary Graft Patency
Secondary patency is defined as the interval from graft placement to graft failure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Two years after Graft Placement
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: Two years after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site
Time frame: At 6 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site
Time frame: At 12 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site
Time frame: At 18 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site
Time frame: At 24 months after Graft Placement
Percentage of Patients With Surgical Site Infection
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time frame: At 6 months after Graft Placement
Percentage of Patients With Surgical Site Infection
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time frame: At 12 months after Graft Placement
Percentage of Patients With Surgical Site Infection
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time frame: At 18 months after Graft Placement
Percentage of Patients With Surgical Site Infection
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Time frame: At 24 months after Graft Placement
Steal Syndrome
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.
Time frame: At 6 months after Graft Placement
Steal Syndrome
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.
Time frame: At 12 months after Graft Placement
Steal Syndrome
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.
Time frame: At 18 months after Graft Placement
Steal Syndrome
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.
Time frame: At 24 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
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
Time frame: At 6 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
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
Time frame: At 12 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
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
Time frame: At 18 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
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
Time frame: At 24 months after Graft Placement