Trial record 5 of 209 for:    Open Studies | angioplasty

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Kidney Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Kidney Foundation
ClinicalTrials.gov Identifier:
NCT00496639
First received: July 3, 2007
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Hyperplasia
Stenosis
Procedure: angioplasty
Procedure: stent placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stent vs. Angioplasty for Treatment of Thrombosed AV Grfats: Long-Term Outcomes

Resource links provided by NLM:


Further study details as provided by National Kidney Foundation:

Primary Outcome Measures:
  • Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision) [ Time Frame: time from initial thrombectomy to next graft intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total cost of access procedures and access complication per year of follow-up [ Time Frame: per year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: October 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: angioplasty
    Balloonplasty of the stenotic lesion at the venous anastomosis of the thrombosed AV graft.
    Other Name: angioplasty
    Procedure: stent placement
    Balloonplasty plus stent deployment at the stenotic lesion at the venous anastomosis of the thrombosed AV graft
    Other Name: Stent deployment
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496639

Contacts
Contact: Ivan D Maya, MD 205-996-2186 imaya@uab.edu
Contact: Michael Allon, MD 205-996-2186 mallon@uab.edu

Locations
United States, Alabama
University of Alabama Hospitals Recruiting
Birmingham, Alabama, United States, 35294
Contact: Ivan D Maya, MD    205-996-2186    imaya@uab.edu   
Principal Investigator: Ivan D Maya, MD         
Sub-Investigator: Michael Allon, MD         
Sub-Investigator: Souheil Saddekni, MD         
Sub-Investigator: Rachel Oser, MD         
Sponsors and Collaborators
National Kidney Foundation
Investigators
Principal Investigator: Ivan D Maya, MD University of Alabama at Birmingham
Study Director: Michael Allon, MD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Dolph Chianchiano, JD, MPA., National Kidney Foundation
ClinicalTrials.gov Identifier: NCT00496639     History of Changes
Other Study ID Numbers: YIG482
Study First Received: July 3, 2007
Last Updated: May 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by National Kidney Foundation:
hemodialysis
arterio-venous grafts
angioplasty
stents
mechanical thrombectomy

Additional relevant MeSH terms:
Constriction, Pathologic
Hyperplasia
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014