Abdominal Aortic AneurysmNCT00922454
Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft
A study testing Endovascular Repair of the abdominal aorta, Cook Zenith Stent-Graft and Talent Stent-Graft in people with Abdominal Aortic Aneurysm, run by Center for Vascular Awareness, Albany, New York at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Endovascular Repair of the abdominal aorta, Cook Zenith Stent-Graft and Talent Stent-Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center, 47 New Scotland Ave.
Albany, New York, 12208
Anita Suchdeve, RN, 518-452-1263, suchdevea@albanyvascular.com
Deborah Hill, RN, (518) 452-1298, hilld@albanyvascular.com
About this study
Official title: Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study
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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Endovascular Repair of the abdominal aorta, Cook Zenith Stent-Graft, Talent Stent-Graft
- Keywords
- patients will be matched based on AAA neck length and neck and iliac angulation
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Repair of the abdominal aortaProcedure or surgery
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 Stent-GraftDevice
Cook Zenith AAA Endovascular Graft
Talent Stent-GraftDevice
Talent AAA Abdominal Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| Talent Stent-Graft | Experimental | Not described Receives: Procedure: Endovascular Repair of the abdominal aorta; Device: Talent Stent-Graft |
| Cook Zenith Stent-Graft | Experimental | Not described Receives: Procedure: Endovascular Repair of the abdominal aorta; Device: Cook Zenith Stent-Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute technical success, successful exclusion of the aneurysm
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vascular Awareness, Albany, New York
- Sponsor type
- University, hospital or other
- Investigators
- Manish Mehta, MD, MPH, Principal investigator, The Vascular Group, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922454
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2009
- First submitted
- 16 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study
- ClinicalTrials.gov ID
- NCT00922454
- Acronym / sponsor ID
- 001
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- patients will be matched based on AAA neck length and neck and iliac angulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Center for Vascular Awareness, Albany, New YorkUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talent Stent-Graft | Experimental | Procedure: Endovascular Repair of the abdominal aorta, Device: Talent Stent-Graft |
| Cook Zenith Stent-Graft | Experimental | Procedure: Endovascular Repair of the abdominal aorta, Device: Cook Zenith Stent-Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Repair of the abdominal aortaPatients 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. | Procedure or surgery | Cook Zenith Stent-Graft, Talent Stent-Graft |
| Cook Zenith Stent-GraftCook Zenith AAA Endovascular Graft | Device | Cook Zenith Stent-Graft |
| Talent Stent-GraftTalent AAA Abdominal Stent Graft System | Device | Talent Stent-Graft |
Primary outcome
Acute technical success, successful exclusion of the aneurysm
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Mehta, MD, MPH principal investigator
The Vascular Group, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Repair of the abdominal aorta, Cook Zenith Stent-Graft and Talent Stent-Graft in people with Abdominal Aortic Aneurysm, run by Center for Vascular Awareness, Albany, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah Hill, RN (518 45202198, hilld@albanyvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute technical success, successful exclusion of the aneurysm (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2009.