<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262467</url>
  </required_header>
  <id_info>
    <org_study_id>AVAH_V1.0</org_study_id>
    <nct_id>NCT03262467</nct_id>
  </id_info>
  <brief_title>Aneurysmorrhaphy of Vascular Access for Haemodialysis</brief_title>
  <acronym>AVAH</acronym>
  <official_title>Aneurysmorrhaphy of Vascular Access for Haemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculty Hospital Kralovske Vinohrady</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculty Hospital Kralovske Vinohrady</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with chronic renal failure, a well-functioning vascular access is essential for&#xD;
      hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular&#xD;
      access, due to a lower incidence of complications and better long-term patency as compared to&#xD;
      prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm&#xD;
      (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality&#xD;
      Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative&#xD;
      treatment, but precise recommendations when and how to intervene in available guidelines are&#xD;
      missing.&#xD;
&#xD;
      Several surgical (remodeling, resection and substitution, ligation) and endovascular&#xD;
      techniques have been described in the AAVF treatment, but there is currently no prospective&#xD;
      randomized study comparing these techniques.&#xD;
&#xD;
      In 2008, our team published the first experience with a new surgical method of AAVF treatment&#xD;
      - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was&#xD;
      validated in several studies and has shown a good long-term patency and a minimal incidence&#xD;
      of complications.&#xD;
&#xD;
      AAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis&#xD;
      (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress,&#xD;
      turbulent flow, endothelial damage, and thrombus formation, which should improve vascular&#xD;
      patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized&#xD;
      study comparing the effect of external porous prosthesis on AVF patency and the incidence of&#xD;
      postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patency and aneurysms recurrence at 12 months after operation</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications at 12 months</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">152</enrollment>
  <condition>Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment</condition>
  <arm_group>
    <arm_group_label>Aneurysmorrhaphy with external porous prosthesis (Provena©)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Aneurysmorrhaphy without external porous prosthesis</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)</intervention_name>
    <description>In patients with aneurysm of native vascular access indicated for surgical treatment, aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) wil be performed.</description>
    <arm_group_label>Aneurysmorrhaphy with external porous prosthesis (Provena©)</arm_group_label>
    <arm_group_label>Aneurysmorrhaphy without external porous prosthesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signature of informed consent.&#xD;
&#xD;
          2. A male or female subject aged 18 or older.&#xD;
&#xD;
          3. A subject with a naive vascular access aneurysm indicated for surgical treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with pseudoaneurysm of prosthetic vascular access&#xD;
&#xD;
          2. Patients with a vascular access infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Peter Baláž, MD, PhD.</last_name>
    <phone>+420776882216</phone>
    <email>balaz.peter.pb@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Surgery, Faculty Hospital Kralovske Vinohrady, 3rd Medical Faculty, Charles University</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Balaz, MD, PhD</last_name>
      <phone>+420 776 882 216</phone>
      <email>balaz.peter.pb@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>14603208</PMID>
  </reference>
  <reference>
    <citation>Salahi 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.</citation>
    <PMID>16797276</PMID>
  </reference>
  <reference>
    <citation>Sidawy 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.</citation>
    <PMID>19000589</PMID>
  </reference>
  <reference>
    <citation>Balaz 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.</citation>
    <PMID>18609522</PMID>
  </reference>
  <reference>
    <citation>Berard 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.</citation>
    <PMID>20202869</PMID>
  </reference>
  <reference>
    <citation>Rokosny 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.</citation>
    <PMID>24530180</PMID>
  </reference>
  <reference>
    <citation>Wohlfahrt 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.</citation>
    <PMID>27225601</PMID>
  </reference>
  <reference>
    <citation>Barra 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.</citation>
    <PMID>3528676</PMID>
  </reference>
  <reference>
    <citation>Meguro 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.</citation>
    <PMID>10764272</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 30, 2022</last_update_submitted>
  <last_update_submitted_qc>July 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculty Hospital Kralovske Vinohrady</investigator_affiliation>
    <investigator_full_name>Peter Balaz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262467
org study id: AVAH_V1.0
nct id: NCT03262467
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patency and aneurysms recurrence at 12 months after operation
time frame: 12 months
measure: Complications at 12 months
time frame: 12 months
arm group label: Aneurysmorrhaphy with external porous prosthesis (Provena©)
arm group type: Active Comparator
arm group label: Aneurysmorrhaphy without external porous prosthesis
arm group type: Placebo Comparator
intervention type: Procedure
intervention name: Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)
description: In patients with aneurysm of native vascular access indicated for surgical treatment, aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) wil be performed.
arm group label: Aneurysmorrhaphy with external porous prosthesis (Provena©)
arm group label: Aneurysmorrhaphy without external porous prosthesis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Baláž, MD, PhD.
phone: +420776882216
email: balaz.peter.pb@gmail.com
facility: 
status: Recruiting
contact: 
country: Czechia
citation: 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.
PMID: 14603208
citation: Salahi 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.
PMID: 16797276
citation: Sidawy 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.
PMID: 19000589
citation: Balaz 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.
PMID: 18609522
citation: Berard 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.
PMID: 20202869
citation: Rokosny 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.
PMID: 24530180
citation: Wohlfahrt 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.
PMID: 27225601
citation: Barra 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.
PMID: 3528676
citation: Meguro 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.
PMID: 10764272
responsible party type: Principal Investigator
investigator affiliation: Faculty Hospital Kralovske Vinohrady
investigator full name: Peter Balaz
investigator title: Principal Investigator
mesh term: Aneurysm
sharing ipd: No