Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

NCT03024372 | Withdrawn FDA Device

• 1 other identifier: Sutures vs Clips AVF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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 suturing techniques.

Conditions

Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• Time to loss of primary patency

  one year post surgery

Secondary Outcomes (13)

• Time to loss of secondary patency

  one year post surgery

• Time to loss of assisted primary patency

  one year post surgery

• Rate of functional maturation

  one year post surgery

• Time to functional maturation

  one year post surgery

• Rate of assumed maturation

  one year post surgery

Study Arms (2)

Conventional sutures

ACTIVE COMPARATOR

AV fistula creation with sutures

Device: AV Fistula creation with sutures

Anastoclips

ACTIVE COMPARATOR

AV fistula creation with clips

Device: AV Fistula creation with clips

Interventions

AV Fistula creation with sutures DEVICE

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.

Conventional sutures

AV Fistula creation with clips DEVICE

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.

Anastoclips

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent in English or Spanish
• Age \< 18 years
• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (3)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of South Florida - South Tampa Campus

Tampa, Florida, 33606, United States

Location

USF Health Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

Related Publications (13)

• 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.

  PMID: 9804495 BACKGROUND

• 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: 10.1016/s0967-2109(01)00088-6.

  PMID: 11604333 BACKGROUND

• 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.

  PMID: 11248171 BACKGROUND

• 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.

  PMID: 11221948 BACKGROUND

• 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.

  PMID: 15852413 BACKGROUND

• 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.

  PMID: 8691738 BACKGROUND

• 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.

  PMID: 21772732 BACKGROUND

• 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.

  PMID: 11877717 BACKGROUND

• 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.

  PMID: 9382393 BACKGROUND

• 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.

  PMID: 12891102 RESULT

• 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.

  PMID: 26806237 RESULT

• 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.

  PMID: 26506936 RESULT

• 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.

  PMID: 11531868 RESULT

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Sutures; Surgical Instruments

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Karl Illig, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 18, 2017
• Study Start: December 1, 2017
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 6, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)