Descending Thoracic Aortic AneurysmTX2 2PASNCT00813358
Zenith TX2® Post-market Approval Study
A study testing Zenith TX2® TAA Endovascular Graft in people with Descending Thoracic Aortic Aneurysm, run by Cook Research Incorporated at 25 sites in 2 countries.
Trial summary
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Descending Thoracic Aortic Aneurysm
- What is being tested?
- Zenith TX2® TAA Endovascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 10 Jul 2009to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
- Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
- Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter
Who cannot join
- Age less than 18 years
- Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
- Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
- Unwilling or unable to comply with the follow-up schedule
- Inability or refusal to give informed consent
- Simultaneously participating in another investigative device or drug study
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States24 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
University of Denver Colorado
Aurora, Colorado, 80045
Cooper University Hospital
Camden, New Jersey, 08103
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Virginia Medical Center
Charlottesville, Virginia, 22908
DFW Vascular Group
Dallas, Texas, 75208
Baylor University Medical Center at Dallas
Dallas, Texas, 75226
New York Hospital of Queens
Flushing, New York, 11355
University of Florida
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
North Shore University Hospital
Manhasset, New York, 11030
New York University
New York, New York, 10016
Heart Care Midwest
Peoria, Illinois, 61614
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Strong Memorial Hospital
Rochester, New York, 14642
Kaiser Permanente
San Francisco, California, 94115
Harborview Medical Center
Seattle, Washington, 98104
Tampa General Hospital
Tampa, Florida, 33601
Montefiore Medical Center
The Bronx, New York, 10467
Iowa Heart Center
West Des Moines, Iowa, 50266
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Zenith TX2® TAA Endovascular Graft Post-approval Study
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.
- Conditions
- Descending Thoracic Aortic Aneurysm
- Being tested
- Zenith TX2® TAA Endovascular Graft
- Keywords
- Endovascular Aneurysm Repair, Aortic Aneurysm, Thoracic
- Medical subject headings
- Descending Thoracic Aortic Aneurysm, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith TX2® TAA Endovascular GraftDevice
Also called TEVAR
Endovascular treatment with the study device
| Study group | Role | What they receive |
|---|---|---|
| Endovascular repair | Experimental | treatment Receives: Device: Zenith TX2® TAA Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study start10 Jul 2009
- Primary completion14 Feb 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Descending Thoracic 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813358
- Sponsor's protocol ID
- 08-005
- Other IDs
- 370024, 2PAS
- Acronym
- TX2 2PAS
- Status last verified
- May 2021
- First submitted
- 19 Dec 2008
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith TX2® TAA Endovascular Graft Post-approval Study
- ClinicalTrials.gov ID
- NCT00813358
- Acronym / sponsor ID
- TX2 2PAS / 08-005
- Conditions
- Descending Thoracic Aortic Aneurysm
- Keywords
- Endovascular Aneurysm Repair, Aortic Aneurysm, Thoracic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2009
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular repair | Experimental | Device: Zenith TX2® TAA Endovascular Grafttreatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
- Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
- Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter
Key exclusion criteria (6 listed)
- Age less than 18 years
- Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
- Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
- Unwilling or unable to comply with the follow-up schedule
- Inability or refusal to give informed consent
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 |
|---|---|---|
| Zenith TX2® TAA Endovascular GraftAlso: TEVAREndovascular treatment with the study device | Device | Endovascular repair |
Primary outcome
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
Time frame: 5 years
Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith TX2® TAA Endovascular Graft in people with Descending Thoracic Aortic Aneurysm, run by Cook Research Incorporated at 25 sites in 2 countries.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality (time frame: 5 years). 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 4 Jun 2021.