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

End Stage Renal Disease Clinical Trial

Official title:

A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03300024
• Other study ID #: IRB00069002
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: February 12, 2018

Study information

• Verified date: May 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Graft
• End Stage Renal Disease
• Hemolysis
• Kidney Failure, Chronic

Intervention

Device:
• 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 to cephalic or suitably sized vein) depending on which location works best in your particular case.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	One year after Graft Placement
Primary	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.	One year after Graft Placement
Primary	Percentage of Patients With Secondary Graft Patency	Secondary patency is defined as the interval from graft placement to graft failure.	One year after Graft Placement
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)	One year after Graft Placement
Primary	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).	Two years after Graft Placement
Primary	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.	Two years after Graft Placement
Primary	Percentage of Patients With Secondary Graft Patency	Secondary patency is defined as the interval from graft placement to graft failure.	Two years after Graft Placement
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)	Two years after Graft Placement
Secondary	Incidence of Pseudoaneurysms Formation at the Access Site		At 6 months after Graft Placement
Secondary	Incidence of Pseudoaneurysms Formation at the Access Site		At 12 months after Graft Placement
Secondary	Incidence of Pseudoaneurysms Formation at the Access Site		At 18 months after Graft Placement
Secondary	Incidence of Pseudoaneurysms Formation at the Access Site		At 24 months after Graft Placement
Secondary	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.	At 6 months after Graft Placement
Secondary	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.	At 12 months after Graft Placement
Secondary	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.	At 18 months after Graft Placement
Secondary	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.	At 24 months after Graft Placement
Secondary	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.	At 6 months after Graft Placement
Secondary	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.	At 12 months after Graft Placement
Secondary	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.	At 18 months after Graft Placement
Secondary	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.	At 24 months after Graft Placement
Secondary	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	At 6 months after Graft Placement
Secondary	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	At 12 months after Graft Placement
Secondary	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	At 18 months after Graft Placement
Secondary	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	At 24 months after Graft Placement