End Stage Renal DiseaseNCT03300024
Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
A study testing Expanded polytetrafluoroethylene Graft and Bovine Carotid Artery Graft in people with End Stage Renal Disease and Hemolysis, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Renal Disease, Hemolysis, Arteriovenous Graft
- What is being tested?
- Expanded polytetrafluoroethylene Graft and Bovine Carotid Artery Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 12 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.
Read the 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.
- Conditions
- End Stage Renal Disease, Hemolysis, Arteriovenous Graft
- Being tested
- Expanded polytetrafluoroethylene Graft, Bovine Carotid Artery Graft
- Keywords
- Hemodialysis, Arteriovenous, Graft, polytetrafluoroethylene, Bovine
- Medical subject headings
- Kidney Failure, Chronic, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded polytetrafluoroethylene GraftDevice
Also called Synthetic 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 GraftDevice
Also called Biological 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Expanded polytetrafluoroethylene Graft |
| 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. Receives: Device: Bovine Carotid Artery Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Two years after Graft Placement
Secondary outcomes (16)
Incidence of Pseudoaneurysms Formation at the Access Site
Measured: At 6 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site
Measured: At 12 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site
Measured: At 18 months after Graft Placement
Incidence of Pseudoaneurysms Formation at the Access Site
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 24 months after Graft Placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Feb 2015
- Primary completion12 Feb 2018
- Study completion12 Feb 2018
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Reifsnyder, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300024
- Sponsor's protocol ID
- IRB00069002
- Status last verified
- May 2019
- First submitted
- 18 Sep 2017
- Last updated
- 21 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29567027
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access
- ClinicalTrials.gov ID
- NCT03300024
- Acronym / sponsor ID
- IRB00069002
- Conditions
- End Stage Renal Disease, Hemolysis, Arteriovenous Graft
- Keywords
- Hemodialysis, Arteriovenous, Graft, polytetrafluoroethylene, Bovine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 14 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Expanded polytetrafluoroethylene (ePTFE) | Active comparator | Device: Expanded polytetrafluoroethylene GraftThe 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 | Device: Bovine Carotid Artery GraftThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded polytetrafluoroethylene GraftAlso: Synthetic GraftGroup 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. | Device | Expanded polytetrafluoroethylene (ePTFE) |
| Bovine Carotid Artery GraftAlso: Biological GraftGroup 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. | Device | Bovine carotid Artery Graft |
Primary outcome
Percentage of Patients With Primary Graft Patency
Time frame: 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
Time frame: 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
Time frame: One year after Graft Placement
Secondary patency is defined as the interval from graft placement to graft failure.
Percentage of Patients With Functional Patency
Time frame: 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
Time frame: Two years 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
Time frame: Two years 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
Time frame: Two years after Graft Placement
Secondary patency is defined as the interval from graft placement to graft failure.
Percentage of Patients With Functional Patency
Time frame: Two years 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)
16 secondary outcomes
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
Time frame: At 6 months after Graft Placement
Percentage of Patients With Surgical Site Infection
Time frame: At 12 months after Graft Placement
Percentage of Patients With Surgical Site Infection
Time frame: At 18 months after Graft Placement
Percentage of Patients With Surgical Site Infection
Time frame: At 24 months after Graft Placement
Steal Syndrome
Time frame: At 6 months after Graft Placement
Steal Syndrome
Time frame: At 12 months after Graft Placement
Steal Syndrome
Time frame: At 18 months after Graft Placement
Steal Syndrome
Time frame: At 24 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Time frame: At 6 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Time frame: At 12 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Time frame: At 18 months after Graft Placement
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
Time frame: At 24 months after Graft Placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29567027Dakour 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.
- Individual participant dataSharing planned: No. 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.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Reifsnyder, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded polytetrafluoroethylene Graft and Bovine Carotid Artery Graft in people with End Stage Renal Disease and Hemolysis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Primary Graft Patency (time frame: One year after Graft Placement). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.