TX2® Low Profile TAA Endovascular Graft

Not Applicable

Completed

• Conditions: Vascular Disease; Aortic Aneurysm; Penetrating Ulcer
• Interventions: Device: Zenith® TX2® Low Profile TAA Endovascular Graft

• Registration Number: NCT01151020
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2014-01
• Disposition First Submitted: 2015-02-09
• Disposition First Submitted QC: 2015-02-09
• Disposition First Posted: 2015-02-26
• Results First Submitted: 2015-10-16
• Results First Submitted QC: 2016-02-01
• Results First Posted: 2016-02-29
• Study Completion: 2018-05-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Zenith® TX2® Low Profile TAA Endovascular Graft	Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)

Primary Outcome Measures

Name	Time	Method
Patients With Major Adverse Events (MAE)	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	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.

Trial Locations

Locations (33)

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Kaiser Permanente; 🇺🇸 San Francisco, California, United States

Tennessee Baptist Memorial Hospital; 🇺🇸 Memphis, Tennessee, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Methodist Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

New York University Hospital; 🇺🇸 New York, New York, United States

Indiana Heart Hospital; 🇺🇸 Indianapolis, Indiana, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

St.George's Hospital; 🇬🇧 London, United Kingdom

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

St. Franziskus Hospital; 🇩🇪 Munster, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

Klinikum Nürnberg Sud; 🇩🇪 Nürnberg, Germany

Jikei University School of Medicine; 🇯🇵 Tokyo, Japan

Uniklinik Regensburg; 🇩🇪 Regensburg, Germany

Keio University Hospital; 🇯🇵 Tokyo, Japan

University Hospital Rostock; 🇩🇪 Rostock, Germany

Morinomiya Hospital; 🇯🇵 Osaka, Japan

Hospital San Raffaele; 🇮🇹 Milan, Italy

Malmö University Hospital; 🇸🇪 Malmö, Sweden

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States