Vascular FistulaNCT02519933

A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients

A study testing mNT-BBAVF and BCAVF in people with Vascular Fistula, run by Shanghai 10th People's Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Vascular Fistula
What is being tested?: mNT-BBAVF and BCAVF
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 2 sitesin 2 countries
Study dates: Apr 2016to 31 Aug 2019
Phase: Interventional
Are there results?: None posted in the registry

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age from 18 to 75 years;
Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;
Brachial artery diameter ≥ 2 mm

Who cannot join

Stenosis or thrombosis present in the draining vein;
A history of peripheral ischemia in upper extremities;
Active local or systemic infections;
Inability to consent for the procedure;
Patients with previous dysfunctional forearm fistula.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Rhode Island Hospital/Brown University Medicine School
Providence, Rhode Island, 02903

Other trials in United States

China1 site

The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072

Other trials in China

About this study

Official title: A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients

A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.

Read the detailed description

The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).

Conditions: Vascular Fistula
Being tested: mNT-BBAVF, BCAVF
Keywords: hemodialysis, vascular access
Medical subject headings: Vascular Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mNT-BBAVFProcedure or surgery
mNT-BBAVF was performed under local anesthesia. A transverse incision of approximately 4 cm was made in the antecubital area. The basilic vein was isolated, and its side branches were ligated; followed by the isolation of brachial artery. A venotomy of 5 mm was performed, followed an arteriotomy of 5 mm. The two vessels then had a side-to-side anastomosis, followed by the ligation of the vein above anastomosis. All the perforating veins located in an area 2-4 cm down the antecubital fossa from anastomosis were separated and ligated carefully. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters (diameters, blood velocities and blood volume) detected by Ultrasound.
BCAVFProcedure or surgery
BCAVF was performed under local anesthesia. A transverse incision of approximately 4 cm in length was made in the medial antecubital area. The cephalic vein was isolated, followed by the isolation of brachial artery. The distal end of cephalic vein was ligated and dissected. Patency of the proximal vein was verified by the warmed saline injection. The artery was then incised after clamping, and an end-to-side anastomosis (4-0 silk suture) between the cephalic vein and the brachial artery was performed. At last the skin is sutured (1-0 silk suture). At last the skin is sutured. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters detected by Ultrasound.

Study groups in NCT02519933
Study group	Role	What they receive
mNT-BBAVF	Active comparator	Patients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access Receives: Procedure: mNT-BBAVF
BCAVF	Active comparator	Patients in CKD stage 4-5 without previous dysfunctional fistula access Receives: Procedure: BCAVF

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary unassited patency
The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.
Measured: 12 months

Secondary outcomes (6)

Cumulative patency
The interval from the time of access placement to access abandonment, including intervening (all surgical and endovascular interventions) designed to reestablish the functionality of thrombosed access.
Measured: 12 month
Short-term complications
Complications of both mNT-BBAVF and BCAVF groups within 1 month (thrombosis, failure of maturation, bleeding, steal syndrome, arm edema and severe arm pain)
Measured: 1 month
Long-term complications
Complications of both mNT-BBAVF and BCAVF groups within 12 months (thrombosis, stenosis and aneurysm).
Measured: 12 months
Calculated blood flow volumes of the corresponding fistula segments
Blood flow volume (ml/min) = mean velocity (cm/s) * area (r2π) * 60 seconds.
Measured: 12 months
Diameters of the veins and arteries in the corresponding arm
Vessels's diameters (cm) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.
Measured: 12 months
Blood flow velocities of the veins and arteries in the corresponding arm.
Blood flow velocities (cm/s) of the relevant veins (proximal cephalic vein, distal cephalic vein, distal basilic vein) and arteries (Subclavian artery, axillary artery, brachial artery, radial artery and ulnar artery) in the corresponding arm.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201631 Aug 2019

First posted11 Aug 2015 (estimated)
Study startApr 2016
Primary completion31 Aug 2018
Study completion31 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vascular FistulaStudies of the same condition, open and under way.
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
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02519933
Sponsor's protocol ID: Shanghai10
Status last verified: Sep 2019
First submitted: 21 Jul 2015
Last updated: 25 Sep 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Fistula trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Modified Non-transposed Brachiobasilic Arteriovenous Fistula and Brachiocephalic Arteriovenous Fistula in Hemodialysis Patients
ClinicalTrials.gov ID: NCT02519933
Acronym / sponsor ID: Shanghai10
Conditions: Vascular Fistula
Keywords: hemodialysis, vascular access
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Shanghai 10th People's HospitalUniversity, hospital or other
Study start: Apr 2016
Primary completion: 31 Aug 2018 (actual)
Study completion: 31 Aug 2019 (actual)
First posted: 11 Aug 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
mNT-BBAVF	Active comparator	Procedure: mNT-BBAVFPatients in Chronic Kidney Disease (CKD) stage 4-5 without previous dysfunctional fistula access
BCAVF	Active comparator	Procedure: BCAVFPatients in CKD stage 4-5 without previous dysfunctional fistula access

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age from 18 to 75 years;
Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm;
Brachial artery diameter ≥ 2 mm

Key exclusion criteria (5 listed)

Stenosis or thrombosis present in the draining vein;
A history of peripheral ischemia in upper extremities;
Active local or systemic infections;
Inability to consent for the procedure;
Patients with previous dysfunctional forearm fistula.

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
mNT-BBAVFmNT-BBAVF was performed under local anesthesia. A transverse incision of approximately 4 cm was made in the antecubital area. The basilic vein was isolated, and its side branches were ligated; followed by the isolation of brachial artery. A venotomy of 5 mm was performed, followed an arteriotomy of 5 mm. The two vessels then had a side-to-side anastomosis, followed by the ligation of the vein above anastomosis. All the perforating veins located in an area 2-4 cm down the antecubital fossa from anastomosis were separated and ligated carefully. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters (diameters, blood velocities and blood volume) detected by Ultrasound.	Procedure or surgery	mNT-BBAVF
BCAVFBCAVF was performed under local anesthesia. A transverse incision of approximately 4 cm in length was made in the medial antecubital area. The cephalic vein was isolated, followed by the isolation of brachial artery. The distal end of cephalic vein was ligated and dissected. Patency of the proximal vein was verified by the warmed saline injection. The artery was then incised after clamping, and an end-to-side anastomosis (4-0 silk suture) between the cephalic vein and the brachial artery was performed. At last the skin is sutured (1-0 silk suture). At last the skin is sutured. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters detected by Ultrasound.	Procedure or surgery	BCAVF

Primary outcome

Primary unassited patency
Time frame: 12 months
The interval from the time of access creation to any first intervention (endovascular or surgical) designed to maintain or reestablish patency, access thrombosis.

6 secondary outcomes

Cumulative patency
Time frame: 12 month
Short-term complications
Time frame: 1 month
Long-term complications
Time frame: 12 months
Calculated blood flow volumes of the corresponding fistula segments
Time frame: 12 months
Diameters of the veins and arteries in the corresponding arm
Time frame: 12 months
Blood flow velocities of the veins and arteries in the corresponding arm.
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
Individual participant dataSharing planned: No

Related trials for Vascular Fistula

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
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Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
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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.

AI Peng, M.D., Ph.D. principal investigator

The Division of Nephrology & Rheumatology, Shanghai 10th People's Hospital

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing mNT-BBAVF and BCAVF in people with Vascular Fistula, run by Shanghai 10th People's Hospital at 2 sites in 2 countries.

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 3 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: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary unassited patency (time frame: 12 months). 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 NCT02519933.

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 25 Sep 2019.