ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00608829TAG 06-02NCT00608829GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic AortaEvaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic AortaW.L.Gore & AssociatesIndustryNo
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.
CompletedFebruary 2007September 2014August 2009Phase 2InterventionalNoN/ASingle Group AssignmentTreatmentNone (Open Label)Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatmentone yearMajor 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).123Aortic Aneurysm, ThoracicGORE TAG® Thoracic EndoprosthesisExperimentalGore 45mm TAG Thoracic Endograft ImplantationDeviceGORE TAG® Thoracic EndoprosthesisImplantGORE TAG® Thoracic EndoprosthesisGORE TAG® Thoracic Endoprosthesis - 45 mm
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
All21 YearsN/ANoMichel Makaroun, MDPrincipal InvestigatorUniversity of Pittsburgh Medical CenterUniversity of Pittsburgh Medical CenterPittsburghPennsylvania15213United StatesUnited StatesMarch 2015December 20, 2007February 5, 2008February 6, 2008August 18, 2010August 18, 2010September 15, 2010March 4, 2015March 4, 2015March 5, 2015SponsorAneurysmAortic AneurysmAortic Aneurysm, Thoracic