Aortic AneurysmTX2® LPNCT01151020
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 Research Incorporated at 33 sites in 6 countries.
Trial summary
The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Mar 2010to 11 May 2018
- 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 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
- Less than 18 years of age
- Life expectancy less than 2 years
- Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent
- Less than 30 days beyond primary endpoint for other investigative drug or device study
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States22 sites
University of Michigan
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
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
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
Tennessee Baptist Memorial Hospital
Memphis, Tennessee, 38120
New York University Hospital
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kaiser Permanente
San Francisco, California, 94115
Harborview Medical Center
Seattle, Washington, 98104
Barnes-Jewish Hospital
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Germany5 sites
Hannover Medical School
Hanover
St. Franziskus Hospital
Münster
Klinikum Nürnberg Sud
Nuremberg, 90471
Uniklinik Regensburg
Regensburg
University Hospital Rostock
Rostock, 18057
Japan3 sites
Morinomiya Hospital
Osaka
Jikei University School of Medicine
Tokyo, 105-8461
Keio University Hospital
Tokyo, 160-8582
About this study
Official title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure 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, TEVAR
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm) Receives: Device: Zenith® TX2® Low Profile TAA Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Major Adverse Events (MAE)
Major adverse event is defined as:
All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Measured: 30 days
Patients With Device Failures
Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2014
- Study completion11 May 2018
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 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Illig, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151020
- Sponsor's protocol ID
- 10-001
- Acronym
- TX2® LP
- Status last verified
- Jan 2021
- First submitted
- 22 Jun 2010
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. 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
- NCT01151020
- Acronym / sponsor ID
- TX2® LP / 10-001
- Conditions
- Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
- Keywords
- Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Posted 29 Feb 2016
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 study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Zenith® TX2® Low Profile TAA Endovascular GraftZenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm) |
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 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
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Life expectancy less than 2 years
- Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- Unwilling 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® Low Profile TAA Endovascular GraftAlso: Zenith Alpha Thoracic™ Endovascular Graft, TEVAREndovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair | Device | Arm 1 |
Primary outcome
Patients With Major Adverse Events (MAE)
Time frame: 30 days
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Patients With Device Failures
Time frame: 12 months
Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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.
Karl Illig, MD principal investigator
University of South Florida
33 sites in 6 countries: 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 Research Incorporated at 33 sites in 6 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Japan, Italy, Sweden and 1 more country. 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 29 Feb 2016). 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?
Patients With Major Adverse Events (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 22 Jan 2021.