Brachiobasilic Arteriovenous FistulaNCT06846580
Role of 2 Stages Brachiobasilic Arteriovenous Fistula in Patients Having Central Venous Stenosis with Exhausted Options of Dialysis Access
An observational study of Brachiobasilic Arteriovenous Fistula, run by Assiut University.
Trial summary
Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula. The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brachiobasilic Arteriovenous Fistula
- What is being tested?
- brachiobasilic AVF
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients with central venous stenosis with exhausted options of dialysis access that has only basilic vein feasible for creation of the fistula
Who may be able to join
- Haemodialysis patients with asymptomatic central venous stenosis that have only basilic vein feasible for creating AVF in one upper limb with exhausted other options for AVF
- Age > 18
- Patent brachial artery by duplex with PSV > 45 cm/s
- Patent Basilic vein with diameter > 3 mm
Who cannot join
- Patient with other arteriovenous access options
- Patient not fit for surgery
- Patient with Peripheral arterial disease at Upper limb
- Patient with history of DVT in upper limb
- Hemodynamically unstable patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula.
The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central [PICC] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.
Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.
Read the detailed description
Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula. The true incidence and prevalence of Central venous stenosis in the ESRD population is unknown because most studies of Central venous stenosis are limited to symptomatic patients. Central venous stenosis may remain asymptomatic because clinical symptoms and signs of Central venous stenosis often develop only after an AVF is placed in the ipsilateral extremity and the impediment to increased blood flow is unmasked. (1) Retrospective investigations of symptomatic HD patients with various accesses using duplex ultrasonography or angiography have reported Central venous stenosis prevalences of 19%-41%. (2-4) The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central [PICC] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.
Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.
our Aims are : Evaluates the efficacy and safety of creation of a Brachiobasilic fistula in hemodialysis patients with central venous stenosis Evaluate the outcomes of Superficialization of the basilic vein after percutaneous transluminal angioplasty of the central venous stenosis
- Conditions
- Brachiobasilic Arteriovenous Fistula
- Being tested
- brachiobasilic AVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachiobasilic AVFProcedure or surgery
perform 2 stage brachiobasilic AVF in hemodialysis patients with central venous stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success of 1st stage Brachiobasilic fistula
Palpable thrill Fistula flow rate with duplex ultrasound
Measured: through study completion, an average of 2 year
Primary patency
It is defined as the interval between initial creation of the fistula and its failing that requires endovascular or surgical intervention.
Measured: through study completion, an average of 2 year
Assisted primary patency
It is defined as the time interval of the fistula remaining patent (functional) with the aid of endovascular intervention.
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
complications of the fistula
Bleeding Infection Thrombosis aneurysm formation Distal limb ischemia Severe venous hypertension.
Measured: through study completion, an average of 2 year
Fistula maturation
It is defined as flow through the fistula greater than 600 ml/minute, vein diameter more than 6 mm and the vein less than 6 mm from the skin and adequate urea clearance with dialysis.
Measured: 4 weeks after the fistula creation and every 2 weeks up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Brachiobasilic Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Hussein Hassan Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846580
- Sponsor's protocol ID
- BBAVF with CVS
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jennings WC, Maliska CM, Blebea J, Taubman KE. Creating arteriovenous fistulas in patients with chronic central venous obstruction. J Vasc Access. 2016 May 7;17(3):239-42. doi: 10.5301/jva.5000507. Epub 2016 Feb 5.
PubMed 26847733Agarwal AK. Central vein stenosis: current concepts. Adv Chronic Kidney Dis. 2009 Sep;16(5):360-70. doi: 10.1053/j.ackd.2009.06.003.
PubMed 19695504Barrett N, Spencer S, McIvor J, Brown EA. Subclavian stenosis: a major complication of subclavian dialysis catheters. Nephrol Dial Transplant. 1988;3(4):423-5. doi: 10.1093/oxfordjournals.ndt.a091691.
PubMed 3140128Schwab SJ, Quarles LD, Middleton JP, Cohan RH, Saeed M, Dennis VW. Hemodialysis-associated subclavian vein stenosis. Kidney Int. 1988 Jun;33(6):1156-9. doi: 10.1038/ki.1988.124.
PubMed 2969991Sticherling C, Chough SP, Baker RL, Wasmer K, Oral H, Tada H, Horwood L, Kim MH, Pelosi F, Michaud GF, Strickberger SA, Morady F, Knight BP. Prevalence of central venous occlusion in patients with chronic defibrillator leads. Am Heart J. 2001 May;141(5):813-6. doi: 10.1067/mhj.2001.114195.
PubMed 11320371Grove JR, Pevec WC. Venous thrombosis related to peripherally inserted central catheters. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):837-40. doi: 10.1016/s1051-0443(07)61797-7.
PubMed 10928518Agarwal AK. Central vein stenosis. Am J Kidney Dis. 2013 Jun;61(6):1001-15. doi: 10.1053/j.ajkd.2012.10.024. Epub 2013 Jan 3.
PubMed 23291234MacRae JM, Ahmed A, Johnson N, Levin A, Kiaii M. Central vein stenosis: a common problem in patients on hemodialysis. ASAIO J. 2005 Jan-Feb;51(1):77-81. doi: 10.1097/01.mat.0000151921.95165.1e.
PubMed 15745139Clark DD, Albina JE, Chazan JA. Subclavian vein stenosis and thrombosis: a potential serious complication in chronic hemodialysis patients. Am J Kidney Dis. 1990 Mar;15(3):265-8. doi: 10.1016/s0272-6386(12)80772-4.
PubMed 2305766
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 2 Stages Brachiobasilic Arteriovenous Fistula in Patients Having Central Venous Stenosis with Exhausted Options of Dialysis Access
- ClinicalTrials.gov ID
- NCT06846580
- Acronym / sponsor ID
- BBAVF with CVS
- Conditions
- Brachiobasilic Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula.
The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central [PICC] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.
Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.
Detailed description
Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula. The true incidence and prevalence of Central venous stenosis in the ESRD population is unknown because most studies of Central venous stenosis are limited to symptomatic patients. Central venous stenosis may remain asymptomatic because clinical symptoms and signs of Central venous stenosis often develop only after an AVF is placed in the ipsilateral extremity and the impediment to increased blood flow is unmasked. (1) Retrospective investigations of symptomatic HD patients with various accesses using duplex ultrasonography or angiography have reported Central venous stenosis prevalences of 19%-41%. (2-4) The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central [PICC] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.
Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.
our Aims are : Evaluates the efficacy and safety of creation of a Brachiobasilic fistula in hemodialysis patients with central venous stenosis Evaluate the outcomes of Superficialization of the basilic vein after percutaneous transluminal angioplasty of the central venous stenosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with central venous stenosis with exhausted options of dialysis access that has only basilic vein feasible for creation of the fistula
Key inclusion criteria (4 listed)
- Haemodialysis patients with asymptomatic central venous stenosis that have only basilic vein feasible for creating AVF in one upper limb with exhausted other options for AVF
- Age > 18
- Patent brachial artery by duplex with PSV > 45 cm/s
- Patent Basilic vein with diameter > 3 mm
Key exclusion criteria (5 listed)
- Patient with other arteriovenous access options
- Patient not fit for surgery
- Patient with Peripheral arterial disease at Upper limb
- Patient with history of DVT in upper limb
- Hemodynamically unstable patients
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 |
|---|---|---|
| brachiobasilic AVFperform 2 stage brachiobasilic AVF in hemodialysis patients with central venous stenosis | Procedure or surgery | – |
Primary outcome
Procedural success of 1st stage Brachiobasilic fistula
Time frame: through study completion, an average of 2 year
Palpable thrill Fistula flow rate with duplex ultrasound
Primary patency
Time frame: through study completion, an average of 2 year
It is defined as the interval between initial creation of the fistula and its failing that requires endovascular or surgical intervention.
Assisted primary patency
Time frame: through study completion, an average of 2 year
It is defined as the time interval of the fistula remaining patent (functional) with the aid of endovascular intervention.
2 secondary outcomes
complications of the fistula
Time frame: through study completion, an average of 2 year
Fistula maturation
Time frame: 4 weeks after the fistula creation and every 2 weeks up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 26847733Jennings WC, Maliska CM, Blebea J, Taubman KE. Creating arteriovenous fistulas in patients with chronic central venous obstruction. J Vasc Access. 2016 May 7;17(3):239-42. doi: 10.5301/jva.5000507. Epub 2016 Feb 5.
- Background: PubMed 19695504Agarwal AK. Central vein stenosis: current concepts. Adv Chronic Kidney Dis. 2009 Sep;16(5):360-70. doi: 10.1053/j.ackd.2009.06.003.
- Background: PubMed 3140128Barrett N, Spencer S, McIvor J, Brown EA. Subclavian stenosis: a major complication of subclavian dialysis catheters. Nephrol Dial Transplant. 1988;3(4):423-5. doi: 10.1093/oxfordjournals.ndt.a091691.
- Background: PubMed 2969991Schwab SJ, Quarles LD, Middleton JP, Cohan RH, Saeed M, Dennis VW. Hemodialysis-associated subclavian vein stenosis. Kidney Int. 1988 Jun;33(6):1156-9. doi: 10.1038/ki.1988.124.
- Background: PubMed 11320371Sticherling C, Chough SP, Baker RL, Wasmer K, Oral H, Tada H, Horwood L, Kim MH, Pelosi F, Michaud GF, Strickberger SA, Morady F, Knight BP. Prevalence of central venous occlusion in patients with chronic defibrillator leads. Am Heart J. 2001 May;141(5):813-6. doi: 10.1067/mhj.2001.114195.
- Background: PubMed 10928518Grove JR, Pevec WC. Venous thrombosis related to peripherally inserted central catheters. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):837-40. doi: 10.1016/s1051-0443(07)61797-7.
- Background: PubMed 23291234Agarwal AK. Central vein stenosis. Am J Kidney Dis. 2013 Jun;61(6):1001-15. doi: 10.1053/j.ajkd.2012.10.024. Epub 2013 Jan 3.
- Background: PubMed 15745139MacRae JM, Ahmed A, Johnson N, Levin A, Kiaii M. Central vein stenosis: a common problem in patients on hemodialysis. ASAIO J. 2005 Jan-Feb;51(1):77-81. doi: 10.1097/01.mat.0000151921.95165.1e.
- Background: PubMed 2305766Clark DD, Albina JE, Chazan JA. Subclavian vein stenosis and thrombosis: a potential serious complication in chronic hemodialysis patients. Am J Kidney Dis. 1990 Mar;15(3):265-8. doi: 10.1016/s0272-6386(12)80772-4.
- Related InfoLink provided by the sponsor.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachiobasilic Arteriovenous Fistula, run by Assiut University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Islam HH Ibrahim (+201016114026, eslamhussein712@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success of 1st stage Brachiobasilic fistula (time frame: through study completion, an average of 2 year). The study lists 3 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 NCT06846580, which also lists 9 linked publications.
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 26 Feb 2025.