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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expanded polytetrafluoroethylene (ePTFE) | Active Comparator | 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. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section. |
|
| Bovine carotid Artery Graft | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expanded polytetrafluoroethylene Graft | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Percentage of Patients With Secondary Graft Patency |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pseudoaneurysms Formation at the Access Site | At 6 months after Graft Placement | |
| Incidence of Pseudoaneurysms Formation at the Access Site | At 12 months after Graft Placement | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Reifsnyder, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29567027 | Derived | Dakour Aridi H, Arhuidese I, Scudder M, Reifsnyder T, Malas MB. A prospective randomized study of bovine carotid artery biologic graft and expanded polytetrafluoroethylene for permanent hemodialysis access. J Vasc Surg. 2018 May;67(5):1606-1612.e4. doi: 10.1016/j.jvs.2017.12.058. Epub 2018 Mar 19. |
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Only key study personnel will be responsible for entering and tracking information. At the end of the study period, study coordinators and research fellows will have access to the final trial dataset and will analyse the data. The final results will be communicated to the PI and co-PI's, the sponsors and participants and will be later published in a peer-reviewed scientific journal.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2015 |
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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
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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.
|
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| Bovine Carotid Artery Graft | Device | 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. |
|
|
Secondary patency is defined as the interval from graft placement to graft failure. |
| 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) | Two years after Graft Placement |
| Incidence of Pseudoaneurysms Formation at the Access Site |
| At 18 months after Graft Placement |
| Incidence of Pseudoaneurysms Formation at the Access Site | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | At 24 months after Graft Placement |
| FG001 | Bovine Carotid Artery Graft | The bovine carotid artery (BCA) 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. |
| COMPLETED |
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| NOT COMPLETED |
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Work on this project was discontinued. Baseline data for "Race and Ethnicity" was not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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) | Data was not collected for this outcome measure | Posted | 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). | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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) | Data was not collected for this outcome measure | Posted | Two years after Graft Placement |
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| Secondary | Incidence of Pseudoaneurysms Formation at the Access Site | Data was not collected for this outcome measure | Posted | At 6 months after Graft Placement |
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| Secondary | Incidence of Pseudoaneurysms Formation at the Access Site | Data was not collected for this outcome measure | Posted | At 12 months after Graft Placement |
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| Secondary | Incidence of Pseudoaneurysms Formation at the Access Site | Data was not collected for this outcome measure | Posted | At 18 months after Graft Placement |
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| Secondary | Incidence of Pseudoaneurysms Formation at the Access Site | Data was not collected for this outcome measure | Posted | At 24 months after Graft Placement |
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| 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | At 24 months after Graft Placement |
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| 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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. | Data was not collected for this outcome measure | Posted | 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 | Data was not collected for this outcome measure | Posted | 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 | Data was not collected for this outcome measure | Posted | 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 | Data was not collected for this outcome measure | Posted | 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 | Data was not collected for this outcome measure | Posted | At 24 months after Graft Placement |
|
Not applicable. Work on this project was discontinued. No adverse event data was collected.
No adverse event data was collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Reifsnyder | Johns Hopkins University | 410-955-7518 | treifsn1@jhmi.edu |
| Feb 28, 2019 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2015 | Feb 28, 2019 | ICF_003.pdf |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D006461 | Hemolysis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic 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 |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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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.
|
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.
|
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.
|
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.
|