TX2® Low Profile TAA Endovascular Graft (TX2® LP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01151020 |
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Recruitment Status :
Active, not recruiting
First Posted : June 25, 2010
Results First Posted : February 29, 2016
Last Update Posted : May 8, 2018
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Sponsor:
Cook Research Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )
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Brief 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 suitable for repair.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aortic Aneurysm Penetrating Ulcer Vascular Disease | Device: Zenith® TX2® Low Profile TAA Endovascular Graft | Not Applicable |
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | January 2014 |
| Estimated Study Completion Date : | February 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
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Device: Zenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Other Names:
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Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151020
Hide Study Locations
Locations
| United States, California | |
| Kaiser Permanente | |
| San Francisco, California, United States, 94115 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Indiana | |
| Methodist Hospital of Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| Indiana Heart Hospital | |
| Indianapolis, Indiana, United States, 46250 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| New York University Hospital | |
| New York, New York, United States, 10016 | |
| Mount Sinai Hospital | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Tennessee Baptist Memorial Hospital | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Virginia | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042 | |
| United States, Washington | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Germany | |
| Hannover Medical School | |
| Hannover, Germany | |
| St. Franziskus Hospital | |
| Munster, Germany | |
| Klinikum Nürnberg Sud | |
| Nürnberg, Germany, 90471 | |
| Uniklinik Regensburg | |
| Regensburg, Germany | |
| University Hospital Rostock | |
| Rostock, Germany, 18057 | |
| Italy | |
| Hospital San Raffaele | |
| Milan, Italy, 20132 | |
| Japan | |
| Morinomiya Hospital | |
| Osaka, Japan | |
| Jikei University School of Medicine | |
| Tokyo, Japan, 105-8461 | |
| Keio University Hospital | |
| Tokyo, Japan, 160-8582 | |
| Sweden | |
| Malmö University Hospital | |
| Malmö, Sweden | |
| United Kingdom | |
| St.George's Hospital | |
| London, United Kingdom, SW 17 0QT | |
Sponsors and Collaborators
Cook Research Incorporated
Investigators
| Principal Investigator: | Karl Illig, MD | University of South Florida |
Additional Information:
| Responsible Party: | Cook Research Incorporated |
| ClinicalTrials.gov Identifier: | NCT01151020 History of Changes |
| Obsolete Identifiers: | NCT00923754 |
| Other Study ID Numbers: |
10-001 |
| First Posted: | June 25, 2010 Key Record Dates |
| Results First Posted: | February 29, 2016 |
| Last Update Posted: | May 8, 2018 |
| Last Verified: | April 2018 |
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
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Aortic Aneurysm Aneurysm Vascular Prosthesis Vascular Disease Blood Vessel Prosthesis Implantation |
Additional relevant MeSH terms:
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Aneurysm Aortic Aneurysm Vascular Diseases Cardiovascular Diseases Aortic Diseases |