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
Recruitment status was Recruiting
Sponsor:
Center for Vascular Awareness, Albany, New York
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
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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. 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. 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 May 16, 2013