Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Center for Vascular Awareness, Albany, New York.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Center for Vascular Awareness, Albany, New York
ClinicalTrials.gov Identifier:
NCT00922454
First received: June 16, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY.

The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.


Condition Intervention
Abdominal Aortic Aneurysm
Procedure: Endovascular Repair of the abdominal aorta
Device: Cook Zenith Stent-Graft
Device: Talent Stent-Graft

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study

Resource links provided by NLM:


Further study details as provided by Center for Vascular Awareness, Albany, New York:

Primary Outcome Measures:
  • Acute technical success, successful exclusion of the aneurysm [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Talent Stent-Graft Procedure: Endovascular Repair of the abdominal aorta

Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft.

EVAR, CTA imaging, 1, 6 12 months post treatment.

Device: Talent Stent-Graft
Talent AAA Abdominal Stent Graft System
Experimental: Cook Zenith Stent-Graft Procedure: Endovascular Repair of the abdominal aorta

Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft.

EVAR, CTA imaging, 1, 6 12 months post treatment.

Device: Cook Zenith Stent-Graft
Cook Zenith AAA Endovascular Graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject with abdominal aortic aneurysm, with or without iliac involvement
  • iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories

Exclusion Criteria:

  • less than 18 years of age
  • pregnant or lactating
  • have contraindications for use of contrast medium or anticoagulation drugs
  • are patients who have a condition that threatens to infect the graft
  • are patients with sensitivities or allergies to the device materials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922454

Contacts
Contact: Deborah Hill, RN 518 45202198 hilld@albanyvascular.com
Contact: Anita Suchdeve, RN 518 452-1263 suchdevea@albanyvascular.com

Locations
United States, New York
Albany Medical Center, 47 New Scotland Ave. Recruiting
Albany, New York, United States, 12208
Contact: Anita Suchdeve, RN    518-452-1263    suchdevea@albanyvascular.com   
Contact: Deborah Hill, RN    (518) 452-1298    hilld@albanyvascular.com   
Sponsors and Collaborators
Center for Vascular Awareness, Albany, New York
Investigators
Principal Investigator: Manish Mehta, MD, MPH The Vascular Group, PLLC
  More Information

No publications provided

Responsible Party: Manish Mehta, MD, The Vascular Group, PLLC
ClinicalTrials.gov Identifier: NCT00922454     History of Changes
Other Study ID Numbers: 001
Study First Received: June 16, 2009
Last Updated: June 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Vascular Awareness, Albany, New York:
patients will be matched based on AAA neck length and neck and iliac angulation

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 15, 2014