TX2® Low Profile TAA Endovascular Graft - Full Text View

Purpose

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	Intervention
Aortic Aneurysm Penetrating Ulcer Vascular Disease	Device: Zenith® TX2® Low Profile TAA Endovascular Graft


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm Vascular Diseases

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:

Patients With Major Adverse Events (MAE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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.


Enrollment:	110
Study Start Date:	March 2010
Estimated Study Completion Date:	December 2019
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)	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: Zenith Alpha Thoracic™ Endovascular Graft TEVAR

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151020

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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
St. 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

Investigators


Principal Investigator:	Karl Illig, MD	University of South Florida

More Information

Additional Information:

Click here for more information about thoracic aortic aneurysms (TAA), aortic ulcers, and the Zenith TX2 Low Profile TAA Endovascular Graft Clinical Study. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site


Responsible Party:	Cook
ClinicalTrials.gov Identifier:	NCT01151020 History of Changes
Obsolete Identifiers:	NCT00923754
Other Study ID Numbers:	10-001
Study First Received:	June 22, 2010
Results First Received:	October 16, 2015
Last Updated:	March 16, 2016
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: Ministry of Health Sweden: Medical Products Agency

Keywords provided by Cook:


Aortic Aneurysm Aneurysm Vascular Prosthesis Vascular Disease Blood Vessel Prosthesis Implantation

Additional relevant MeSH terms:


Aneurysm Vascular Diseases Aortic Aneurysm Cardiovascular Diseases Aortic Diseases

ClinicalTrials.gov processed this record on September 30, 2016

TX2® Low Profile TAA Endovascular Graft (TX2® LP)