Patients With an Aneurysm of Native Vascular Access Indicated for Surgical TreatmentAVAHNCT03262467
Aneurysmorrhaphy of Vascular Access for Haemodialysis
A study testing Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) in people with Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
In patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular access, due to a lower incidence of complications and better long-term patency as compared to prosthetic arteriovenous fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment
- What is being tested?
- Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteCzechia
- Study dates
- 31 Jan 2018to 1 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of informed consent.
- A male or female subject aged 18 or older.
- A subject with a naive vascular access aneurysm indicated for surgical treatment.
Who cannot join
- Patients with pseudoaneurysm of prosthetic vascular access
- Patients with a vascular access infection
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Surgery, Faculty Hospital Kralovske Vinohrady, 3rd Medical Faculty, Charles University
Prague
About this study
In patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular access, due to a lower incidence of complications and better long-term patency as compared to prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative treatment, but precise recommendations when and how to intervene in available guidelines are missing.
Several surgical (remodeling, resection and substitution, ligation) and endovascular techniques have been described in the AAVF treatment, but there is currently no prospective randomized study comparing these techniques.
Read more
In 2008, our team published the first experience with a new surgical method of AAVF treatment - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was validated in several studies and has shown a good long-term patency and a minimal incidence of complications.
AAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress, turbulent flow, endothelial damage, and thrombus formation, which should improve vascular patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized study comparing the effect of external porous prosthesis on AVF patency and the incidence of postoperative complications.
- Being tested
- Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)Procedure or surgery
In patients with aneurysm of native vascular access indicated for surgical treatment, aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) wil be performed.
| Study group | Role | What they receive |
|---|---|---|
| Aneurysmorrhaphy with external porous prosthesis (Provena©) | Active comparator | Not described Receives: Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) |
| Aneurysmorrhaphy without external porous prosthesis | Placebo comparator | Not described Receives: Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency and aneurysms recurrence at 12 months after operation
Measured: 12 months
Secondary outcomes (1)
Complications at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start31 Jan 2018
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
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 Patients With an Aneurysm of Native Vascular Access Indicated for Surgical TreatmentStudies 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Peter Balaz, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262467
- Sponsor's protocol ID
- AVAH_V1.0
- Acronym
- AVAH
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2017
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huber TS, Carter JW, Carter RL, Seeger JM. Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: a systematic review. J Vasc Surg. 2003 Nov;38(5):1005-11. doi: 10.1016/s0741-5214(03)00426-9.
PubMed 14603208Salahi H, Fazelzadeh A, Mehdizadeh A, Razmkon A, Malek-Hosseini SA. Complications of arteriovenous fistula in dialysis patients. Transplant Proc. 2006 Jun;38(5):1261-4. doi: 10.1016/j.transproceed.2006.02.066.
PubMed 16797276Sidawy AN, Spergel LM, Besarab A, Allon M, Jennings WC, Padberg FT Jr, Murad MH, Montori VM, O'Hare AM, Calligaro KD, Macsata RA, Lumsden AB, Ascher E; Society for Vascular Surgery. The Society for Vascular Surgery: clinical practice guidelines for the surgical placement and maintenance of arteriovenous hemodialysis access. J Vasc Surg. 2008 Nov;48(5 Suppl):2S-25S. doi: 10.1016/j.jvs.2008.08.042.
PubMed 19000589Balaz P, Rokosny S, Klein D, Adamec M. Aneurysmorrhaphy is an easy technique for arteriovenous fistula salvage. J Vasc Access. 2008 Apr-Jun;9(2):81-4.
PubMed 18609522Berard X, Brizzi V, Mayeux S, Sassoust G, Biscay D, Ducasse E, Bordenave L, Corpataux JM, Midy D. Salvage treatment for venous aneurysm complicating vascular access arteriovenous fistula: use of an exoprosthesis to reinforce the vein after aneurysmorrhaphy. Eur J Vasc Endovasc Surg. 2010 Jul;40(1):100-6. doi: 10.1016/j.ejvs.2010.01.021. Epub 2010 Mar 3.
PubMed 20202869Rokosny S, Balaz P, Wohlfahrt P, Palous D, Janousek L. Reinforced aneurysmorrhaphy for true aneurysmal haemodialysis vascular access. Eur J Vasc Endovasc Surg. 2014 Apr;47(4):444-50. doi: 10.1016/j.ejvs.2014.01.010. Epub 2014 Jan 21.
PubMed 24530180Wohlfahrt P, Rokosny S, Melenovsky V, Borlaug BA, Pecenkova V, Balaz P. Cardiac remodeling after reduction of high-flow arteriovenous fistulas in end-stage renal disease. Hypertens Res. 2016 Sep;39(9):654-9. doi: 10.1038/hr.2016.50. Epub 2016 May 26.
PubMed 27225601Barra JA, Volant A, Leroy JP, Braesco J, Airiau J, Boschat J, Blanc JJ, Penther P. Constrictive perivenous mesh prosthesis for preservation of vein integrity. Experimental results and application for coronary bypass grafting. J Thorac Cardiovasc Surg. 1986 Sep;92(3 Pt 1):330-6.
PubMed 3528676Meguro T, Nakashima H, Kawada S, Tokunaga K, Ohmoto T. Effect of external stenting and systemic hypertension on intimal hyperplasia in rat vein grafts. Neurosurgery. 2000 Apr;46(4):963-9; discussion 969-70. doi: 10.1097/00006123-200004000-00036.
PubMed 10764272
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysmorrhaphy of Vascular Access for Haemodialysis
- ClinicalTrials.gov ID
- NCT03262467
- Acronym / sponsor ID
- AVAH / AVAH_V1.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Aug 2017 (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 patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular access, due to a lower incidence of complications and better long-term patency as compared to prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative treatment, but precise recommendations when and how to intervene in available guidelines are missing.
Several surgical (remodeling, resection and substitution, ligation) and endovascular techniques have been described in the AAVF treatment, but there is currently no prospective randomized study comparing these techniques.
In 2008, our team published the first experience with a new surgical method of AAVF treatment - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was validated in several studies and has shown a good long-term patency and a minimal incidence of complications.
AAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress, turbulent flow, endothelial damage, and thrombus formation, which should improve vascular patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized study comparing the effect of external porous prosthesis on AVF patency and the incidence of postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aneurysmorrhaphy with external porous prosthesis (Provena©) | Active comparator | Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) |
| Aneurysmorrhaphy without external porous prosthesis | Placebo comparator | Procedure: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signature of informed consent.
- A male or female subject aged 18 or older.
- A subject with a naive vascular access aneurysm indicated for surgical treatment.
Key exclusion criteria (2 listed)
- Patients with pseudoaneurysm of prosthetic vascular access
- Patients with a vascular access infection
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 |
|---|---|---|
| Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)In patients with aneurysm of native vascular access indicated for surgical treatment, aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) wil be performed. | Procedure or surgery | Aneurysmorrhaphy with external porous prosthesis (Provena©), Aneurysmorrhaphy without external porous prosthesis |
Primary outcome
Patency and aneurysms recurrence at 12 months after operation
Time frame: 12 months
1 secondary outcome
Complications at 12 months
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 28 Feb 2024.
- Background: PubMed 14603208Huber TS, Carter JW, Carter RL, Seeger JM. Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: a systematic review. J Vasc Surg. 2003 Nov;38(5):1005-11. doi: 10.1016/s0741-5214(03)00426-9.
- Background: PubMed 16797276Salahi H, Fazelzadeh A, Mehdizadeh A, Razmkon A, Malek-Hosseini SA. Complications of arteriovenous fistula in dialysis patients. Transplant Proc. 2006 Jun;38(5):1261-4. doi: 10.1016/j.transproceed.2006.02.066.
- Background: PubMed 19000589Sidawy AN, Spergel LM, Besarab A, Allon M, Jennings WC, Padberg FT Jr, Murad MH, Montori VM, O'Hare AM, Calligaro KD, Macsata RA, Lumsden AB, Ascher E; Society for Vascular Surgery. The Society for Vascular Surgery: clinical practice guidelines for the surgical placement and maintenance of arteriovenous hemodialysis access. J Vasc Surg. 2008 Nov;48(5 Suppl):2S-25S. doi: 10.1016/j.jvs.2008.08.042.
- Background: PubMed 18609522Balaz P, Rokosny S, Klein D, Adamec M. Aneurysmorrhaphy is an easy technique for arteriovenous fistula salvage. J Vasc Access. 2008 Apr-Jun;9(2):81-4.
- Background: PubMed 20202869Berard X, Brizzi V, Mayeux S, Sassoust G, Biscay D, Ducasse E, Bordenave L, Corpataux JM, Midy D. Salvage treatment for venous aneurysm complicating vascular access arteriovenous fistula: use of an exoprosthesis to reinforce the vein after aneurysmorrhaphy. Eur J Vasc Endovasc Surg. 2010 Jul;40(1):100-6. doi: 10.1016/j.ejvs.2010.01.021. Epub 2010 Mar 3.
- Background: PubMed 24530180Rokosny S, Balaz P, Wohlfahrt P, Palous D, Janousek L. Reinforced aneurysmorrhaphy for true aneurysmal haemodialysis vascular access. Eur J Vasc Endovasc Surg. 2014 Apr;47(4):444-50. doi: 10.1016/j.ejvs.2014.01.010. Epub 2014 Jan 21.
- Background: PubMed 27225601Wohlfahrt P, Rokosny S, Melenovsky V, Borlaug BA, Pecenkova V, Balaz P. Cardiac remodeling after reduction of high-flow arteriovenous fistulas in end-stage renal disease. Hypertens Res. 2016 Sep;39(9):654-9. doi: 10.1038/hr.2016.50. Epub 2016 May 26.
- Background: PubMed 3528676Barra JA, Volant A, Leroy JP, Braesco J, Airiau J, Boschat J, Blanc JJ, Penther P. Constrictive perivenous mesh prosthesis for preservation of vein integrity. Experimental results and application for coronary bypass grafting. J Thorac Cardiovasc Surg. 1986 Sep;92(3 Pt 1):330-6.
- Background: PubMed 10764272Meguro T, Nakashima H, Kawada S, Tokunaga K, Ohmoto T. Effect of external stenting and systemic hypertension on intimal hyperplasia in rat vein grafts. Neurosurgery. 2000 Apr;46(4):963-9; discussion 969-70. doi: 10.1097/00006123-200004000-00036.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) in people with Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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 2 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 28 Feb 2024. 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 Czechia. 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. Some participants in this study may receive a placebo. 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?
Patency and aneurysms recurrence at 12 months after operation (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 NCT03262467, 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 28 Feb 2024.