Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

NCT01669850 | Terminated

• 1 other identifier: 2-12-07-002
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.

Conditions

Arteriovenous Fistula Complications and Failure

Keywords

Chronic kidney disease; Arteriovenous fistula; Surgical anastomosis; Complications; Patency; Dialysis access

Outcome Measures

Primary Outcomes (1)

• Patency rates

  Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.

  2 years postoperative

Secondary Outcomes (1)

• Surgical complications

  2 years postoperative

Other Outcomes (1)

• Cost

  1 year postoperative

Study Arms (2)

Clipped anastomosis

EXPERIMENTAL

A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.

Device: Clipped anastomosis

Handsewn anastomosis

ACTIVE COMPARATOR

A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.

Procedure: Handsewn anastomosis

Interventions

Clipped anastomosis DEVICE

The vascular clip devise will be used to complete the anastomosis during fistula creation.

Also known as: Anastoclip (Le Maitre)

Clipped anastomosis

Handsewn anastomosis PROCEDURE

a handsewn anastomosis technique will be used during fistula creation.

Handsewn anastomosis

Eligibility Criteria

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

You may qualify if:

• years of age or older.
• Need for AVF creation for vascular access for planned hemodialysis (within 1 year).
• The planned AVF site must be naïve of prior AVF creations.
• Vein mapping studies completed
• mm minimum vein diameter on mapping

You may not qualify if:

• Less than 18 years of age.
• Inability to provide consent.
• Previous failed AVFs in both arms.
• Contraindications to AVF creation:
• ipsilateral proximal venous and arterial occlusion or stenosis
• systemic or local infection
• too ill to operate
• Anticipated inability to keep 30-day postoperative follow-up appointment.

Sponsors & Collaborators

• Gundersen Lutheran Medical Foundation: lead
• Gundersen Lutheran Health System: collaborator

Study Sites (1)

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (5)

• Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. doi: 10.1067/mva.2001.112806.

  PMID: 11296337 BACKGROUND

• Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. doi: 10.1016/j.amjsurg.2003.08.007.

  PMID: 14672769 BACKGROUND

• Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21.

  PMID: 22104322 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 BACKGROUND

• Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. doi: 10.1177/153857440503900509.

  PMID: 16193217 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Clark A Davis, MD

  Gundersen Lutheran Health System

  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: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Research Associate, on behalf of Clark Davis, MD (PI)

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 21, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

US (1)