Aortic AneurysmNCT02471781
Zenith® TX2® Low Profile TAA Endovascular Graft
A study testing Zenith TX2 Low Profile TAA Endovascular Graft in people with Aortic Aneurysm and Penetrating Ulcer, run by Cook Group Incorporated at 15 sites in United States.
Trial summary
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
- What is being tested?
- Zenith TX2 Low Profile TAA Endovascular Graft
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Meets one of the following
- Descending thoracic aneurysm with diameter ≥ 5.0 cm
- Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
- Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter
Who cannot join
- Life expectancy less than 2 years
- Pregnant of breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
- Less than 30 days beyond primary endpoint for other investigative drug or device study
- Receiving home oxygen
- Myocardial infarction within the last 3 months
Show all 13Show fewer
- Stroke within the last 3 months
- Diagnosed or suspected congenital degenerative collagen disease
- Systemic infection
- Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
- Allergy to polyester, polypropylene, nitinol, or gold
- Previous placement of a thoracic endovascular graft
- Prior open repair involving the descending thoracic aorta
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Cooper University Hospital
Camden, New Jersey, 08103
University of North Carolina
Chapel Hill, North Carolina, 27599
Ohio State University
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
Indiana Heart Hospital
Indianapolis, Indiana, 46250
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
The Mount Sinai Hospital
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Barnes-Jewish Hospital
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.
- Conditions
- Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
- Being tested
- Zenith TX2 Low Profile TAA Endovascular Graft
- Keywords
- Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation
- Medical subject headings
- Aortic Aneurysm, Penetrating Atherosclerotic Ulcer, Vascular Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith TX2 Low Profile TAA Endovascular GraftDevice
Also called Zenith Alpha Thoracic™ Endovascular Graft
Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Illig, MD, Principal investigator, Dialysis Access Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471781
- Sponsor's protocol ID
- 10-001 CA
- Status last verified
- Jan 2020
- First submitted
- 11 Jun 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
- ClinicalTrials.gov ID
- NCT02471781
- Acronym / sponsor ID
- 10-001 CA
- Conditions
- Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
- Keywords
- Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 15 Jun 2015 (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 Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets one of the following
Key exclusion criteria (13 listed)
- Life expectancy less than 2 years
- Pregnant of breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
- Less than 30 days beyond primary endpoint for other investigative drug or device study
- Receiving home oxygen
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 Low Profile TAA Endovascular GraftAlso: Zenith Alpha Thoracic™ Endovascular GraftEndovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Karl Illig, MD principal investigator
Dialysis Access Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith TX2 Low Profile TAA Endovascular Graft in people with Aortic Aneurysm and Penetrating Ulcer, run by Cook Group Incorporated at 15 sites 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 4 inclusion and 13 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Jan 2020.