Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
Trial ID or NCT#
NCT02021812
Status
NOT RECRUITING
Purpose
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)
Official Title
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Presence of DTA aneurysm deemed to warrant surgical repair which requires proximal graft placement in Zone 2:
- 1. Fusiform (≥ 55 mm), or 2. Fusiform (\>2 times native aortic diameter), or 3. Saccular (no diameter criteria)2. Age ≥18 years at time of informed consent signature3. Subject is capable of complying with protocol requirements, including follow-up4. Informed Consent Form (ICF) is signed by Subject or legal representative5. Must have appropriate proximal aortic landing zone, defined as:
- 1. Must require coverage of the left subclavian artery (LSA) origin for exclusion of the lesion 2. Aortic inner diameters between 16-48 mm 3. Landing zone, which must include the LSA ostium, cannot be aneurysmal, heavily calcified, or heavily thrombosed, 4. Acceptable proximal landing zone outer curvature length for the required device 5. Landing zone must be native aorta6. Must have appropriate distal aortic landing zone, defined as:
- 1. Outer curvature length must be ≥2cm proximal to the celiac artery 2. Aortic inner diameters between 16-48mm (diameter should be between 16-42mm if using distal TAG® Device extension) 3. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed 4. Native aorta or previously implanted GORE® TAG® Device7. Must have appropriate LSA landing zone, defined as:
- 1. LSA length of ≥3 cm proximal to first major branch vessel if using Aortic Component with 8 mm portal diameter, or LSA length of ≥2.5 cm proximal to first major branch vessel if using Aortic Component with 12 mm portal diameter 2. LSA inner diameters of 6-15 mm if using Aortic Component with 8 mm portal diameter, or inner diameters of 11-18 mm if using Aortic Component with 12 mm portal diameter 3. Target branch vessel landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
Exclusion Criteria:
- 1. Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair2. Previous endovascular repair of the ascending aorta3. Previous endovascular repair of the DTA with a non-Gore device4. Surgery within 30 days of treatment5. Infected aorta6. Dissection of the DTA7. Intramural hematoma of the DTA without DTA aneurysm8. Life expectancy \<2 years9. Myocardial infarction or stroke within 6 weeks prior to treatment10. Patient has a systemic infection and may be at increased risk of endovascular graft infection11. Pregnant female at time of informed consent signature12. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome13. Participation in another drug or medical device study within one year of study enrollment14. Known history of drug abuse within one year of treatment15. Significant thrombus or atheroma in the aortic arch16. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access17. Planned coverage of left carotid or celiac arteries18. Patient has known sensitivities or allergies to the device materials19. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment20. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin21. Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper22. Mycotic aneurysm23. Persistent refractory shock (systolic blood pressure \<90 mm Hg)24. Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
- Additionally, the following exclusion criteria apply for Subjects enrolled in Stage 1:25. Aberrant right subclavian or left vertebral arteries26. Occluded/stenosed/hypoplastic right vertebral artery27. Presence of a patent left internal mammary artery (LIMA) graft28. Bilateral carotid artery disease29. Known incomplete Circle of Willis30. Known left vertebral artery ending in posterior inferior cerebellar artery (PICA)
Investigator(s)
Michael Fischbein
Cardiothoracic surgeon
Thelma and Henry Doelger Professor of Cardiovascular Surgery
View on ClinicalTrials.gov
