Clinical trial NCT02264977: Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms
Official title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (Branched TAG® Device) in the Treatment of Aortic Arch Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysm of Aortic Arch
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to assess the early feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the aortic arch

Detailed description: The GORE® TAG® Thoracic Endoprosthesis (TAG® Device) received premarket approval (PMA) for use in endovascular aneurysm repair of the descending thoracic aorta (DTA) on 23-Mar-2005 under P040043, and design changes that resulted in the conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) received premarket approval for the treatment of aneurysms of the DTA on 23-Aug-2011 (P040043/S039). The TAG® Device and CTAG are intended to exclude an aneurysm from the blood circulation in patients diagnosed with DTA aneurysms. However, endovascular treatment options for patients with aortic arch aneurysms are limited as current stent graft technology would require coverage of aortic arch vessels. This prompted the creation of the GORE® TAG® Thoracic Branch Endoprosthesis (previously known as Branched TAG® Device), which was being evaluated under IDE G130120 for Zone 2 aneurysms when this clinical investigation was initiated to evaluate the GORE® TAG® Thoracic Branch Endoprosthesis for the treatment of Zone 0 and Zone 1 aneurysms of the aortic arch.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Study Device Access
timeFrame: During treatment procedure (day 0)
measure: Number of Participants With Successful Study Device Deployment
timeFrame: During treatment procedure (day 0)
measure: Number of Participants With Primary Procedural Side Branch Patency
timeFrame: At conclusion of the treatment procedure (day 0)
Secondary outcomes:
measure: Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab
timeFrame: 1 Month
measure: Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab
timeFrame: 1 Month
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Leland Stanford Junior University
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Lebanon
country: United States
facility: The Hitchcock Foundation (Dartmouth Hitchcock Medical Center)
state: New Hampshire
city: Philadelphia
country: United States
facility: Hospital at University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univerisity of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Michael D Dake, MD
role: PRINCIPAL_INVESTIGATOR
References: