Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms

• ClinicalTrials.gov Identifier: NCT02021812
• Recruitment Status: Active, not recruiting
• First Posted: December 27, 2013
• Results First Posted: August 2, 2017
• Last Update Posted: August 12, 2020
• Sponsor: W.L.Gore & Associates
• Information provided by (Responsible Party): W.L.Gore & Associates

Study Description

Brief 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 proximal Descending Thoracic Aorta (DTA)

Condition or disease	Intervention/treatment	Phase
Aortic Aneurysm, Thoracic	Device: Branched TAG® Device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms
• Actual Study Start Date: January 2014
• Actual Primary Completion Date: August 2016
• Estimated Study Completion Date: June 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Branched TAG® Device; Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis	Device: Branched TAG® Device

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Successful Study Device Access [ Time Frame: During treatment procedure (day 0) ]
   Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.
2. Number of Participants With Successful Study Device Deployment [ Time Frame: During treatment procedure (day 0) ]
   Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.
3. Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography [ Time Frame: At conclusion of the treatment procedure (day 0) ]
   The presence of forward flow through the implanted Side Branch Component into the target branch vessel.

Secondary Outcome Measures :

1. Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab [ Time Frame: 1 month post procedure ]
2. Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab [ Time Frame: 1 month post procedure ]
   Device-related endoelaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the adjacent tissue (endoleak type IA or IB) OR the junction between the Aortic Component and either the SB Component or the Aortic Extender (type III endoleak).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 signature
3. Subject is capable of complying with protocol requirements, including follow-up
4. Informed Consent Form (ICF) is signed by Subject or legal representative

5. 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 aorta

6. 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® Device

7. 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 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 DTA
7. Intramural hematoma of the DTA without DTA 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 left carotid or celiac arteries
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

    Additionally, the following exclusion criteria apply for Subjects enrolled in Stage 1:

25. Aberrant right subclavian or left vertebral arteries
26. Occluded/stenosed/hypoplastic right vertebral artery
27. Presence of a patent left internal mammary artery (LIMA) graft
28. Bilateral carotid artery disease
29. Known incomplete Circle of Willis
30. Known left vertebral artery ending in posterior inferior cerebellar artery (PICA)

Contacts and Locations

Locations

United States, California

Leland Stanford Junior University

Stanford, California, United States, 94305-5407

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Minnesota

Mayo Clinic - Rochester

Rochester, Minnesota, United States, 55905

United States, New Hampshire

The Hitchcock Foundation (Dartmouth Hitchcock Medical Center)

Lebanon, New Hampshire, United States, 03756

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

W.L.Gore & Associates

Investigators

• Principal Investigator: Michael D Dake, MD; Stanford University

More Information

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT02021812
• Other Study ID Numbers: SSB 11-02
• First Posted: December 27, 2013
• Results First Posted: August 2, 2017
• Last Update Posted: August 12, 2020
• Last Verified: July 2020

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases