TX2® Low Profile TAA Endovascular Graft

Aortic Aneurysm Clinical Trial

— TX2® LP  

Official title:

Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151020
• Other study ID #: 10-001
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: May 11, 2018

Study information

• Verified date: January 2021
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 suitable for repair.

Other known NCT identifiers

• NCT00923754

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 11, 2018
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Penetrating Ulcer
• Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover
Germany	St. Franziskus Hospital	Munster
Germany	Klinikum Nürnberg Sud	Nürnberg
Germany	Uniklinik Regensburg	Regensburg
Germany	University Hospital Rostock	Rostock
Italy	Hospital San Raffaele	Milan
Japan	Morinomiya Hospital	Osaka
Japan	Jikei University School of Medicine	Tokyo
Japan	Keio University Hospital	Tokyo
Sweden	Malmö University Hospital	Malmö
United Kingdom	St.George's Hospital	London
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Cooper University Hospital	Camden	New Jersey
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Indiana Heart Hospital	Indianapolis	Indiana
United States	Methodist Hospital of Indiana	Indianapolis	Indiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Tennessee Baptist Memorial Hospital	Memphis	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	New York University Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Kaiser Permanente	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	University of South Florida	Tampa	Florida
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Japan,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Primary	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.	12 months

External Links

•   Click here for more information about thoracic aortic aneurysms (TAA), aortic ulcers, and the Zenith TX2 Low Profile TAA Endovascular Graft Clinical Study.