Arteriovenous FistulaNCT04613115
Relationship Between Arterial Variations and Patency of Arteriovenous Fistulae
An observational study of Arteriovenous Fistula and Ultrasound, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
In 2019, KDOQI considered that uremic patients with a life expectancy of more than one year should require hemodialysis as an effective renal replacement therapy before preparation of kidney transplantation. Arteriovenous fistula, as the lifeline of uremic patients, plays an important role in their daily hemodialysis. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arteriovenous Fistula, Ultrasound, Artery
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients who were admitted to the vascular surgical Inpatient department from outpatient department.
Who may be able to join
- patients of vascular surgical Inpatient department
- patients will sign the "Informed Consent" and be able to receive related ultrasound examinations
Who cannot join
- Patients of other surgical Inpatient department
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
About this study
Official title: Study on the Relationship Between Variations in the Branching Pattern of the Main Arteries and Patency of Arteriovenous Fistulae in the Upper Limb
In 2019, KDOQI considered that uremic patients with a life expectancy of more than one year should require hemodialysis as an effective renal replacement therapy before preparation of kidney transplantation. Arteriovenous fistula, as the lifeline of uremic patients, plays an important role in their daily hemodialysis. The patency of arteriovenous fistula is largely restricted by the inflow artery. According to available medical literatures, an incidence rate of variations in the branching pattern of the main arteries in the upper limb is ranged from 7.2% to 25.0%. and there is a large difference in the incidence rate between sex and race, furthermore, the incidence rate of variations in the branching pattern of the main arteries in the upper limb of Chinese is still unclear. The brachial artery is the main artery of the upper limb. It gives off two terminal branches at the distal end of the elbow crease, the radial and ulnar arteries, the former one often serves as an arterial inflow to create an arteriovenous fistula in the forearm. High bifurcation of the brachial artery (HBBA) seems to be a common variation which may result in immaturity or disfunction of arteriovenous fistulas. Therefore, the purpose of this study is to investigate the variations in the branching pattern of the main arteries in the upper limb of Chinese, in order to study on the hemodynamic changes, and their influence on the establishment, maturation and failure of arteriovenous fistulas in the upper limb.
Read the detailed description
This is a prospective analysis research, collecting information after patients admission, including basic information, primary disease status, dialysis intubation status, current dialysis access status, last dialysis access maintenance status and other relevant data. The above-mentioned information data is collected when the patient is admitted into the department of vascular surgery, and is recorded in the "Information Collection, Diagnosis and Treatment Process of Hemodialysis Patients in the Department of Vascular Surgery" form for retention and filing.
During the study period, all patients who were admitted to the vascular surgical department and signed the "Informed Consent" before the upper extremity artery screening according to the corresponding procedures.
- Conditions
- Arteriovenous Fistula, Ultrasound, Artery
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients without uremia and variant arteries | |
| Group B | patients without uremia, but with variant arteries | |
| Group C | patients with uremia ,without variant arteries | |
| Group D | patients with uremia and variant arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
the variations in the branching pattern of the main arteries in the upper limb of Chinese.
brachio-radial artery、superficial brachio-radial artery、brachio-ulnar artery、superficial brachio-ulnar artery、brachioulnoradial artery、brachiointerosseous artery.
Measured: baseline
Patency of arteriovenous fistulae in the upper limb
functional patency、primary patency、primary assisted patency、secondary patency
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZhengYa Yu, MD, Study director, Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.Xin Chen, MM, Principal investigator, Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613115
- Sponsor's protocol ID
- TRECKY2020-101
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
KEEN JA. A study of the arterial variations in the limbs, with special reference to symmetry of vascular patterns. Am J Anat. 1961 May;108:245-61. doi: 10.1002/aja.1001080303. No abstract available.
PubMed 14454801Tsoucalas G, Eleftheriou A, Panagouli E. High Bifurcation of the Brachial Artery: An Embryological Overview. Cureus. 2020 Feb 25;12(2):e7097. doi: 10.7759/cureus.7097.
PubMed 32231893Aragao JA, da Silva AC, Anunciacao CB, Reis FP. Median artery of the forearm in human fetuses in northeastern Brazil: anatomical study and review of the literature. Anat Sci Int. 2017 Jan;92(1):107-111. doi: 10.1007/s12565-015-0322-x. Epub 2016 Jan 8.
PubMed 26747631Cikla U, Mukherjee D, Tumturk A, Baskaya MK. Overcoming End-to-End Vessel Mismatch During Superficial Temporal Artery-Radial Artery-M2 Interposition Grafting for Cerebral Ischemia: Tapering Technique. World Neurosurg. 2018 Feb;110:85. doi: 10.1016/j.wneu.2017.10.162. Epub 2017 Nov 6.
PubMed 29122732Jennings WC, Mallios A, Mushtaq N. Proximal radial artery arteriovenous fistula for hemodialysis vascular access. J Vasc Surg. 2018 Jan;67(1):244-253. doi: 10.1016/j.jvs.2017.06.114. Epub 2017 Sep 11.
PubMed 28912005Kachlik D, Hajek P, Konarik M, Krchov M, Baca V. Coincidence of superficial brachiomedian artery and bitendinous palmaris longus: a case report. Surg Radiol Anat. 2016 Jan;38(1):147-51. doi: 10.1007/s00276-015-1512-x. Epub 2015 Jul 2.
PubMed 26134151Shetty SD, Nayak B S, Madhav N V, Sirasanagandla SR, P A. The abnormal origin, course and the distribution of the arteries of the upper limb: a case report. J Clin Diagn Res. 2012 Oct;6(8):1414-6. doi: 10.7860/JCDR/2012/4183.2373.
PubMed 23205361Singer G, Marterer R, Till H, Schmidt B. A rare anatomic variation of the superficial palmar branch of the radial artery causing pain. Surg Radiol Anat. 2018 Mar;40(3):349-352. doi: 10.1007/s00276-017-1936-6. Epub 2017 Nov 9.
PubMed 29124345Lee H, Moon YS, Park HS, Kim HT, Choi IJ. A radial artery originating from the thoracoacromial artery. Surg Radiol Anat. 2016 Jul;38(5):631-3. doi: 10.1007/s00276-015-1576-7. Epub 2015 Oct 22.
PubMed 26493986Nasr AY. The radial artery and its variations: anatomical study and clinical implications. Folia Morphol (Warsz). 2012 Nov;71(4):252-62.
PubMed 23197145Wysiadecki G, Polguj M, Haladaj R, Topol M. Low origin of the radial artery: a case study including a review of literature and proposal of an embryological explanation. Anat Sci Int. 2017 Mar;92(2):293-298. doi: 10.1007/s12565-016-0371-9. Epub 2016 Sep 15.
PubMed 27631096Hamahata A, Nakazawa H, Takeuchi M, Sakurai H. Usefulness of radial recurrent artery in transplant of radial forearm flap: an anatomical and clinical study. J Reconstr Microsurg. 2012 Mar;28(3):195-8. doi: 10.1055/s-0031-1301071. Epub 2012 Jan 24.
PubMed 22274767Vazquez T, Sanudo JR, Carretero J, Parkin I, Rodriguez-Niedenfuhr M. Variations of the radial recurrent artery of clinical interest. Surg Radiol Anat. 2013 Oct;35(8):689-94. doi: 10.1007/s00276-013-1094-4. Epub 2013 Feb 26.
PubMed 23440497Rodriguez-Niedenfuhr M, Vazquez T, Nearn L, Ferreira B, Parkin I, Sanudo JR. Variations of the arterial pattern in the upper limb revisited: a morphological and statistical study, with a review of the literature. J Anat. 2001 Nov;199(Pt 5):547-66. doi: 10.1046/j.1469-7580.2001.19950547.x.
PubMed 11760886Lioupis C, Mistry H, Junghans C, Haughey N, Freedman B, Tyrrell M, Valenti D. High brachial artery bifurcation is associated with failure of brachio-cephalic autologous arteriovenous fistulae. J Vasc Access. 2010 Apr-Jun;11(2):132-7. doi: 10.1177/112972981001100209.
PubMed 20155716
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Variations in the Branching Pattern of the Main Arteries and Patency of Arteriovenous Fistulae in the Upper Limb
- ClinicalTrials.gov ID
- NCT04613115
- Acronym / sponsor ID
- TRECKY2020-101
- Conditions
- Arteriovenous Fistula, Ultrasound, Artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Nov 2020 (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.
In 2019, KDOQI considered that uremic patients with a life expectancy of more than one year should require hemodialysis as an effective renal replacement therapy before preparation of kidney transplantation. Arteriovenous fistula, as the lifeline of uremic patients, plays an important role in their daily hemodialysis. The patency of arteriovenous fistula is largely restricted by the inflow artery. According to available medical literatures, an incidence rate of variations in the branching pattern of the main arteries in the upper limb is ranged from 7.2% to 25.0%. and there is a large difference in the incidence rate between sex and race, furthermore, the incidence rate of variations in the branching pattern of the main arteries in the upper limb of Chinese is still unclear. The brachial artery is the main artery of the upper limb. It gives off two terminal branches at the distal end of the elbow crease, the radial and ulnar arteries, the former one often serves as an arterial inflow to create an arteriovenous fistula in the forearm. High bifurcation of the brachial artery (HBBA) seems to be a common variation which may result in immaturity or disfunction of arteriovenous fistulas. Therefore, the purpose of this study is to investigate the variations in the branching pattern of the main arteries in the upper limb of Chinese, in order to study on the hemodynamic changes, and their influence on the establishment, maturation and failure of arteriovenous fistulas in the upper limb.
Detailed description
This is a prospective analysis research, collecting information after patients admission, including basic information, primary disease status, dialysis intubation status, current dialysis access status, last dialysis access maintenance status and other relevant data. The above-mentioned information data is collected when the patient is admitted into the department of vascular surgery, and is recorded in the "Information Collection, Diagnosis and Treatment Process of Hemodialysis Patients in the Department of Vascular Surgery" form for retention and filing.
During the study period, all patients who were admitted to the vascular surgical department and signed the "Informed Consent" before the upper extremity artery screening according to the corresponding procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –patients without uremia and variant arteries |
| Group B | – | –patients without uremia, but with variant arteries |
| Group C | – | –patients with uremia ,without variant arteries |
| Group D | – | –patients with uremia and variant arteries |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients who were admitted to the vascular surgical Inpatient department from outpatient department.
Key inclusion criteria (2 listed)
- patients of vascular surgical Inpatient department
- patients will sign the "Informed Consent" and be able to receive related ultrasound examinations
Key exclusion criteria (1 listed)
- Patients of other surgical Inpatient department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the variations in the branching pattern of the main arteries in the upper limb of Chinese.
Time frame: baseline
brachio-radial artery、superficial brachio-radial artery、brachio-ulnar artery、superficial brachio-ulnar artery、brachioulnoradial artery、brachiointerosseous artery.
Patency of arteriovenous fistulae in the upper limb
Time frame: 1 year
functional patency、primary patency、primary assisted patency、secondary patency
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 21 Sep 2023.
- Background: PubMed 14454801KEEN JA. A study of the arterial variations in the limbs, with special reference to symmetry of vascular patterns. Am J Anat. 1961 May;108:245-61. doi: 10.1002/aja.1001080303. No abstract available.
- Background: PubMed 32231893Tsoucalas G, Eleftheriou A, Panagouli E. High Bifurcation of the Brachial Artery: An Embryological Overview. Cureus. 2020 Feb 25;12(2):e7097. doi: 10.7759/cureus.7097.
- Background: PubMed 26747631Aragao JA, da Silva AC, Anunciacao CB, Reis FP. Median artery of the forearm in human fetuses in northeastern Brazil: anatomical study and review of the literature. Anat Sci Int. 2017 Jan;92(1):107-111. doi: 10.1007/s12565-015-0322-x. Epub 2016 Jan 8.
- Background: PubMed 29122732Cikla U, Mukherjee D, Tumturk A, Baskaya MK. Overcoming End-to-End Vessel Mismatch During Superficial Temporal Artery-Radial Artery-M2 Interposition Grafting for Cerebral Ischemia: Tapering Technique. World Neurosurg. 2018 Feb;110:85. doi: 10.1016/j.wneu.2017.10.162. Epub 2017 Nov 6.
- Background: PubMed 28912005Jennings WC, Mallios A, Mushtaq N. Proximal radial artery arteriovenous fistula for hemodialysis vascular access. J Vasc Surg. 2018 Jan;67(1):244-253. doi: 10.1016/j.jvs.2017.06.114. Epub 2017 Sep 11.
- Background: PubMed 26134151Kachlik D, Hajek P, Konarik M, Krchov M, Baca V. Coincidence of superficial brachiomedian artery and bitendinous palmaris longus: a case report. Surg Radiol Anat. 2016 Jan;38(1):147-51. doi: 10.1007/s00276-015-1512-x. Epub 2015 Jul 2.
- Background: PubMed 23205361Shetty SD, Nayak B S, Madhav N V, Sirasanagandla SR, P A. The abnormal origin, course and the distribution of the arteries of the upper limb: a case report. J Clin Diagn Res. 2012 Oct;6(8):1414-6. doi: 10.7860/JCDR/2012/4183.2373.
- Background: PubMed 29124345Singer G, Marterer R, Till H, Schmidt B. A rare anatomic variation of the superficial palmar branch of the radial artery causing pain. Surg Radiol Anat. 2018 Mar;40(3):349-352. doi: 10.1007/s00276-017-1936-6. Epub 2017 Nov 9.
- Background: PubMed 26493986Lee H, Moon YS, Park HS, Kim HT, Choi IJ. A radial artery originating from the thoracoacromial artery. Surg Radiol Anat. 2016 Jul;38(5):631-3. doi: 10.1007/s00276-015-1576-7. Epub 2015 Oct 22.
- Background: PubMed 23197145Nasr AY. The radial artery and its variations: anatomical study and clinical implications. Folia Morphol (Warsz). 2012 Nov;71(4):252-62.
- Background: PubMed 27631096Wysiadecki G, Polguj M, Haladaj R, Topol M. Low origin of the radial artery: a case study including a review of literature and proposal of an embryological explanation. Anat Sci Int. 2017 Mar;92(2):293-298. doi: 10.1007/s12565-016-0371-9. Epub 2016 Sep 15.
- Background: PubMed 22274767Hamahata A, Nakazawa H, Takeuchi M, Sakurai H. Usefulness of radial recurrent artery in transplant of radial forearm flap: an anatomical and clinical study. J Reconstr Microsurg. 2012 Mar;28(3):195-8. doi: 10.1055/s-0031-1301071. Epub 2012 Jan 24.
- Individual participant dataSharing planned: No
Related trials for Arteriovenous Fistula
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
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
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
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.
ZhengYa Yu, MD study director
Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.
Xin Chen, MM principal investigator
Department of Vascular Surgery, Beijing Tongren Hospital, Capital Medical University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula and Ultrasound, run by Beijing Tongren Hospital at 1 site in China.
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 2 inclusion and 1 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 21 Sep 2023. 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 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?
the variations in the branching pattern of the main arteries in the upper limb of Chinese. (time frame: baseline). The study lists 2 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 NCT04613115, which also lists 19 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 21 Sep 2023.