GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.

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Key information

Conditions

Aortic Aneurysm, Thoracic Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

Fusiform (≥50 mm), or
Saccular (no diameter criteria)
All proximal and/or all distal landing zone inner diameters between 37-42 mm

Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications
Proximal and distal landing zone length greater than 2.0 cm

Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
Life expectancy > 2 years
Subject is open surgical candidate defined as:

Able to tolerate thoracotomy
American Society of Anesthesiologists class I-IV (class V excluded)
New York Heart Association class I-III or not applicable (class IV excluded)
Male or infertile female
Age greater than 21 years
Able to comply with study protocol requirements, including follow-up

Exclusion criteria

Mycotic aneurysm
Hemodynamically unstable aneurysm rupture
Aortic dissection
Planned occlusion of left carotid or celiac arteries
Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
Myocardial infarction or stroke within 6 weeks of treatment
Pre-treatment creatinine > 2.0 mg/dL
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or device study within 1 year of treatment
History of drug abuse within 6 months of treatment

Treatment and study plan

GORE TAG® Thoracic Endoprosthesis

Device

Implant

Other names: GORE TAG® Thoracic Endoprosthesis - 45 mm

Primary outcomes

Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment

Time frame: one year

Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2014
First posted: Feb 6, 2008
Registry last updated: Mar 5, 2015

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