Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device)

Condition: Aortic aneurysm, thoracic aortic aneurysm, aortic diseases, vascular diseases, aorta lesion

Eligibility

Key Inclusion Criteria (all subjects)

  • Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement
  • At least 18 years old
  • Must have appropriate proximal aortic landing zone and target branch vessel landing zone

Key Exclusion Criteria (all subjects)

  • Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
  • Previous endovascular repair of the ascending aorta
  • Pregnancy

Full Study Name

Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (IRB no. 45245)

Summary

This study is designed to evaluate the safety and effectiveness of an investigational device called GORE TAG Thoracic Branch Endoprosthesis (TBE Device) for patients who have one of the following conditions: a bulge in the aortic wall (aneurysm) caused by weakening in the aortic wall, a tear in the aortic wall (dissection), bleeding and blood clots within the aortic wall (intramural hematoma), a lesion (wound) or ulcer in the aortic wall caused by aortic disease, or traumatic injury to the aorta that can result in a tear, lesion, or rupture of the aortic wall. The TBE device will be used to treat the aortic condition by covering the diseased or injured part of the aortic wall. Because of the location of the aortic disease or injury, the device will be implanted inside the patient’s aorta and one of the main arteries that branches off the aorta.

Participants are admitted to the study in one of two groups. "Zone 0-1" participants will undergo a surgical procedure called a revascularization to reconnect the branched arteries that will be covered by the TBE device. This surgery will redirect blood flow to necessary organs and tissues; they will then undergo the procedure using the study device. "Zone 2" participants will not be revascularized before having the device implanted.

Financial disclosure: Ali Azizzadeh, MD, the principal investigator, received a payment from the company sponsoring this study for consulting fees in the past. The investigator and institution have no current or other potential financial conflict of interest with respect to this study.

Phase

Phase III


Principal Investigator

Ali Azizzadeh, MD

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