Overview

This trial is active, not recruiting.

Condition aneurysm of aortic arch
Treatment branched tag® device
Sponsor W.L.Gore & Associates
Start date April 2015
End date May 2016
Trial size 9 participants
Trial identifier NCT02264977, SSB 11-03

Summary

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 aortic arch

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
branched tag® device

Primary Outcomes

Measure
Successful access of the Study Device
time frame: During treatment procedure (day 0)
Successful deployment of Study Device
time frame: During treatment procedure (day 0)
Primary procedural side branch patency
time frame: At conclusion of the treatment procedure (day 0)

Secondary Outcomes

Measure
1 month side branch primary patency assessed by an independent Core Lab
time frame: 1 month post procedure
1 month device related endoleaks assessed by an independent Core Lab
time frame: 1 month post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Presence of aortic aneurysm involving the aortic arch deemed to warrant surgical repair which requires proximal graft placement in Zone 0 or Zone 1: 1. Fusiform (≥ 55 mm), or 2. Fusiform (>2 times native aortic diameter), or 3. Saccular (no diameter criteria) 2. Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator 3. Age ≥18 years at time of informed consent signature 4. Subject is capable of complying with protocol requirements, including follow-up 5. Informed Consent Form (ICF) is signed by Subject or legal representative 6. Must have appropriate proximal aortic landing zone, defined as: 1. Must require placement of the proximal extent of the Aortic Component in Zone 0 or Zone 1 for exclusion of the lesion 2. Acceptable proximal landing zone outer curvature length for the required device 3. Landing zone inner diameters between 16-48 mm in Zone 1 Subjects and 24-48mm in Zone 0 Subjects 4. Landing zone, which must include either the brachiocephalic or left common carotid native ostium, cannot be aneurysmal, heavily calcified, or heavily thrombosed 7. 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 16-48 mm (diameter must be between 16-42mm if using distal TAG® Device extension) 3. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed 4. Landing zone in native aorta or previously implanted GORE® TAG® Device 8. Must have appropriate target branch vessel landing zone, defined as: 1. Length of ≥3 cm proximal to first major branch vessel if using Aortic Component with 8 mm portal diameter, or length of ≥2.5 cm proximal to first major branch vessel if using Aortic Component with 12 mm portal diameter (required for Zone 0 Subjects) 2. Target branch vessel inner diameters of 6-15 mm if using Aortic Component with 8mm portal diameter, or inner diameters of 11-18 mm if using Aortic Component with 12mm portal diameter (required for Zone 0 Subjects) 3. Target branch vessel landing zone must be in native aorta that cannot be aneurysmal, heavily calcified, or heavily thrombosed Exclusion Criteria: 1. Concomitant aneurysm/disease of the ascending aorta, or abdominal aorta requiring repair 2. Previous endovascular repair of the ascending aorta 3. Previous endovascular repair of the DTA with a non-Gore device 4. Surgery within 30 days of treatment 5. Infected aorta 6. Dissection of the aorta 7. Intramural hematoma of the aortic arch or DTA without aneurysm 8. Life expectancy <2 years 9. Myocardial infarction or stroke within 6 weeks prior to treatment 10. Patient has a systemic infection and may be at increased risk of endovascular graft infection 11. Pregnant female at time of informed consent signature 12. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 13. Participation in another drug or medical device study within one year of study enrollment 14. Known history of drug abuse within one year of treatment 15. Significant thrombus or atheroma in the aortic arch 16. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access 17. Planned coverage of celiac artery 18. Patient has known sensitivities or allergies to the device materials 19. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment 20. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 21. 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 taper 22. Mycotic aneurysm 23. 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

Additional Information

Official title Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (Branched TAG® Device) in the Treatment of Aortic Arch Aneurysms
Principal investigator Michael D Dake, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.