TX2® Low Profile TAA Endovascular Graft

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.

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Key information

Conditions

Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Penetrating Atherosclerotic Ulcer Penetrating Ulcer Vascular Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School, Hanover, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenith® TX2® Low Profile TAA Endovascular Graft

Device

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Acronym: TX2® LP

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2018
First posted: Jun 25, 2010
Registry last updated: Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed