Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes

NCT00496639 | Unknown

• 1 other identifier: YIG482
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Arteriovenous grafts are used as the vascular access in 40-50% of hemodialysis patients. Grafts are prone to recurrent stenosis (narrowing) and thrombosis (clotting). Graft clotting is usually due to a narrowing at the site where the graft joins the vein. The standard treatment is to remove the clot and angioplasty the narrowed area. The long-term outcome is not good, lasting only about 1 month. Placing a stent (a small metallic, PTFE covered, spring) at the narrowed site may keep the graft open longer. Principal investigator's preliminary research data suggest that placing a stent at the stenotic site prolongs graft patency following thrombectomy, as compared to conventional angioplasty. This is a single-center, randomized clinical trial, in which patients with a clotted graft with underlying stenosis at the venous anastomosis of the graft will be allocated to thrombectomy + angioplasty (control group) or to thrombectomy + stent placement (study group). The primary endpoint will be primary (unassisted) graft patency. The secondary endpoints will be secondary (assisted) graft patency and overall access-related costs.

Conditions

Hyperplasia; Stenosis

Keywords

hemodialysis; arterio-venous grafts; angioplasty; stents; mechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision)

  time from initial thrombectomy to next graft intervention

Secondary Outcomes (1)

• Total cost of access procedures and access complication per year of follow-up

  per year follow-up

Interventions

angioplasty PROCEDURE

Balloonplasty of the stenotic lesion at the venous anastomosis of the thrombosed AV graft.

stent placement PROCEDURE

Balloonplasty plus stent deployment at the stenotic lesion at the venous anastomosis of the thrombosed AV graft

Also known as: Stent deployment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established dialysis patient with a recent thrombosed AV graft (less than 48 hours).
• AV grafts can be located at the forearm, upper arm or thigh.
• Either first or second episode of thrombosis of the AV graft.
• Stenotic lesion at the venous anastomosis greater than 50% at time of initial intervention.

You may not qualify if:

• Established ESRD patients with a recent thrombosed AV fistula.
• Prior participation in this study.
• Prior Stent placement at the venous anastomosis.
• Inability to restore blood flow after mechanical thrombectomy.
• Stenotic lesion at other venous site (i.e. venous outlet or central vessels)
• Three or more prior mechanical thrombectomies and angioplasties of the same graft.
• Stenotic lesion at the venous anastomosis less than 50%

Sponsors & Collaborators

• National Kidney Foundation, United States: lead

Study Sites (1)

University of Alabama Hospitals

Birmingham, Alabama, 35294, United States

RECRUITING

Related Publications (4)

• Maya ID, Allon M. Outcomes of thrombosed arteriovenous grafts: comparison of stents vs angioplasty. Kidney Int. 2006 Mar;69(5):934-7. doi: 10.1038/sj.ki.5000214.

  PMID: 16518354 BACKGROUND

• Maya ID, Saddekni S, Allon M. Treatment of refractory central vein stenosis in hemodialysis patients with stents. Semin Dial. 2007 Jan-Feb;20(1):78-82. doi: 10.1111/j.1525-139X.2007.00246.x.

  PMID: 17244127 BACKGROUND

• Maya ID, Oser R, Saddekni S, Barker J, Allon M. Vascular access stenosis: comparison of arteriovenous grafts and fistulas. Am J Kidney Dis. 2004 Nov;44(5):859-65.

  PMID: 15492952 BACKGROUND

• Fonseca AV, Toledo Barros MG, Baptista-Silva JC, Amorim JE, Vasconcelos V. Interventions for thrombosed haemodialysis arteriovenous fistulas and grafts. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD013293. doi: 10.1002/14651858.CD013293.pub2.

  PMID: 38353936 DERIVED

MeSH Terms

Conditions

Hyperplasia; Constriction, Pathologic

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Ivan D Maya, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Michael Allon, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Central Study Contacts

Ivan D Maya, MD

CONTACT

205-996-2186; imaya@uab.edu

Michael Allon, MD

CONTACT

205-996-2186; mallon@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: October 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: May 22, 2008

Record last verified: 2008-05

Locations

US (1)