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Arteriovenous FistulaNCT03024372

Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

A study testing AV Fistula creation with sutures and AV Fistula creation with clips in people with Arteriovenous Fistula, run by University of South Florida at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arteriovenous Fistula
What is being tested?
AV Fistula creation with sutures and AV Fistula creation with clips
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Dec 2017to Aug 2024
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

  • Requiring brachiocephalic fistula judged to be best option for access after vein mapping (Surgeons will be required to do 10 cases using Anastoclips prior to enrolling)
  • Able to provide informed consent in English or Spanish
  • Age 18 years or greater
  • With estimated life expectancy of 2 years or more
  • Able to comply with study procedures including all scheduled follow-up visits

Who cannot join

  • Unable to provide informed consent in English or Spanish
  • Age < 18 years
  • With pacemaker, IACD, or other permanent obstructive device on that side (a temporary tunneled dialysis catheter is not an exclusion)
  • Unable (or in surgeon's judgment a poor risk) to comply with study procedures and follow-up visits
  • With estimated life expectancy of less than 2 years
  • Females must be either:
  • Of non-childbearing potential, which is defined as post-menopausal (at least 12 months without menses prior to Treatment Day) or documented surgically sterile or post hysterectomy (at least 1 month prior to Treatment Day)
  • Or, of childbearing potential, in which case must have a negative urine pregnancy test at Treatment Day

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Tampa General Hospital

    Tampa, Florida, 33606

  • University of South Florida - South Tampa Campus

    Tampa, Florida, 33606

  • USF Health Carol and Frank Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

Read the detailed description

This will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. The study intervention will be randomization between conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group), which provide an interrupted closure without intimal penetration.

Being tested
AV Fistula creation with sutures, AV Fistula creation with clips
Medical subject headings
Arteriovenous Fistula

What participants receive

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

  • AV Fistula creation with suturesDevice

    End-to-side anastomosis (of AV fistula) is to be constructed using sutures. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.

  • AV Fistula creation with clipsDevice

    End-to-side anastomosis (of AV fistula) is to be constructed using clips. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.

Study groups in NCT03024372
Study groupRoleWhat they receive
Conventional suturesActive comparatorAV fistula creation with sutures
Receives: Device: AV Fistula creation with sutures
AnastoclipsActive comparatorAV fistula creation with clips
Receives: Device: AV Fistula creation with clips

What is being measured

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

  1. Time to loss of primary patency

    Measured: one year post surgery

Secondary outcomes (13)

  1. Time to loss of secondary patency

    Measured: one year post surgery

  2. Time to loss of assisted primary patency

    Measured: one year post surgery

  3. Rate of functional maturation

    in patients on dialysis

    Measured: one year post surgery

  4. Time to functional maturation

    in patients on dialysis

    Measured: one year post surgery

  5. Rate of assumed maturation

    in patients not on dialysis

    Measured: one year post surgery

  6. Time to assumed maturation

    in patients not on dialysis

    Measured: one year post surgery

  7. Rate of complications

    thrombosis/thrombectomy, stenosis, skin erosion, limb swelling, steal syndrome, bleeding and hematoma formation at surgical site, surgical-site-related infection, access-related infection, rupture, revision

    Measured: 30 days post surgery

  8. Rate of intervention

    to maintain patency

    Measured: five years post surgery

  9. Operative cost

    Measured: duration of surgery

  10. Overall cost

    Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days

    Measured: time of surgery to time of hospital discharge (can range from 1 day to 1 week or more)

  11. Time to loss of primary patency

    Measured: 5 years post surgery

  12. Time to loss of assisted primary patency

    Measured: 5 years post surgery

  13. Time to loss of secondary patency

    Measured: 5 years post surgery

Timeline

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

  1. First posted18 Jan 2017 (estimated)
  2. Study startDec 2017 (estimated)
  3. Primary completionFeb 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Why it stopped: Study did not get started. Investigator is no longer at this institution

Resources

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
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03024372
Sponsor's protocol ID
Sutures vs Clips AVF
Status last verified
Oct 2017
First submitted
6 Jan 2017
Last updated
6 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Haruguchi H, Nakagawa Y, Uchida Y, Sageshima J, Fuchinoue S, Agishi T. Clinical application of vascular closure staple clips for blood access surgery. ASAIO J. 1998 Sep-Oct;44(5):M562-4. doi: 10.1097/00002480-199809000-00050.

    PubMed 9804495

  • Schild AF, Pruett CS, Newman MI, Raines J, Petersen F, Konkin T, Kim P, Dickson C, Kirsch WM. The utility of the VCS clip for creation of vascular access for hemodialysis: long-term results and intraoperative benefits. Cardiovasc Surg. 2001 Dec;9(6):526-30. doi: 10.1177/096721090100900602.

    PubMed 11604333

  • Cook JW, Schuman ES, Standage BA, Heinl P. Patency and flow characteristics using stapled vascular anastomoses in dialysis grafts. Am J Surg. 2001 Jan;181(1):24-7. doi: 10.1016/s0002-9610(00)00547-x.

    PubMed 11248171

  • Cooper BZ, Flores L, Ramirez JA, Najjar JG, Abir F, Rayham R, Paladino L, Nguyen M, Panetta TF. Analysis of nonpenetrating clips versus sutures for arterial venous graft anastomosis. Ann Vasc Surg. 2001 Jan;15(1):7-12. doi: 10.1007/s100160010001.

    PubMed 11221948

  • Zeebregts CJ. Randomized clinical trial of continuous sutures or non-penetrating clips for radiocephalic arteriovenous fistula (Br J Surg 2004; 91: 1438-1442). Br J Surg. 2005 May;92(5):654-5. doi: 10.1002/bjs.5063. No abstract available.

    PubMed 15852413

  • Sukhatme VP. Vascular access stenosis: prospects for prevention and therapy. Kidney Int. 1996 Apr;49(4):1161-74. doi: 10.1038/ki.1996.167. No abstract available.

    PubMed 8691738

  • Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.

    PubMed 21772732

  • Sidawy AN, Gray R, Besarab A, Henry M, Ascher E, Silva M Jr, Miller A, Scher L, Trerotola S, Gregory RT, Rutherford RB, Kent KC. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg. 2002 Mar;35(3):603-10. doi: 10.1067/mva.2002.122025.

    PubMed 11877717

  • Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. doi: 10.7326/0003-4819-127-8_part_2-199710151-00063.

    PubMed 9382393

  • Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc Surg. 2003 Aug;38(2):229-35. doi: 10.1016/s0741-5214(03)00412-9.

    PubMed 12891102

  • Nguyen KP, Teruya T, Alabi O, Sheng N, Bianchi C, Chiriano J, Dehom S, Abou-Zamzam A. Comparison of Nonpenetrating Titanium Clips versus Continuous Polypropylene Suture in Dialysis Access Creation. Ann Vasc Surg. 2016 Apr;32:15-9. doi: 10.1016/j.avsg.2015.11.008. Epub 2016 Jan 22.

    PubMed 26806237

  • Aitken E, Jeans E, Aitken M, Kingsmore D. A randomized controlled trial of interrupted versus continuous suturing techniques for radiocephalic fistulas. J Vasc Surg. 2015 Dec;62(6):1575-82. doi: 10.1016/j.jvs.2015.07.083. Epub 2015 Oct 23.

    PubMed 26506936

  • Zeebregts C, van den Dungen J, Buikema H, van der Want J, van Schilfgaarde R. Preservation of endothelial integrity and function in experimental vascular anastomosis with non-penetrating clips. Br J Surg. 2001 Sep;88(9):1201-8. doi: 10.1046/j.0007-1323.2001.01857.x.

    PubMed 11531868

Questions about this trial

What is this clinical trial studying?

A study testing AV Fistula creation with sutures and AV Fistula creation with clips in people with Arteriovenous Fistula, run by University of South Florida at 3 sites in United States.

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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

Time to loss of primary patency (time frame: one year post surgery). 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 NCT03024372, which also lists 13 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 6 Jul 2018.

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