GORE TAG® Thoracic Endoprosthesis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Aortic Aneurysm, Thoracic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gore 45mm TAG Thoracic Endograft Implantation

Group Type EXPERIMENTAL

GORE TAG® Thoracic Endoprosthesis

Intervention Type DEVICE

Implant

Interventions

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GORE TAG® Thoracic Endoprosthesis

Implant

Intervention Type DEVICE

Other Intervention Names

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GORE TAG® Thoracic Endoprosthesis - 45 mm

Eligibility Criteria

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Inclusion Criteria

1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

* Fusiform (≥50 mm), or
* Saccular (no diameter criteria)
2. 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
3. Proximal and distal landing zone length greater than 2.0 cm

* Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
4. Life expectancy \> 2 years
5. 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)
6. Male or infertile female
7. Age greater than 21 years
8. Able to comply with study protocol requirements, including follow-up

Exclusion Criteria

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No