Aneurysm of Aortic Arch
Conditions
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.
Interventions
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Study Device Access | During treatment procedure (day 0) | Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques. |
| Number of Participants With Successful Study Device Deployment | 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. |
| Number of Participants With Primary Procedural Side Branch Patency | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab | 1 Month | — |
| Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab | 1 Month | Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (Type IA or IB) or the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (Type III). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Branched TAG® Device Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Refuse to return | 1 |
Baseline characteristics
| Characteristic | Branched TAG® Device |
|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 8 |
| BMI, Continuous | 26.2 kg/(m^2) STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 9 |
| other Total, other adverse events | 8 / 9 |
| serious Total, serious adverse events | 9 / 9 |
Outcome results
Primary
Number of Participants With Primary Procedural Side Branch Patency
The presence of forward flow through the implanted Side Branch Component into the target branch vessel.
Time frame: At conclusion of the treatment procedure (day 0)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Branched TAG® Device | Number of Participants With Primary Procedural Side Branch Patency | 9 Participants |
Primary
Number of Participants With Successful Study Device Access
Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.
Time frame: During treatment procedure (day 0)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Branched TAG® Device | Number of Participants With Successful Study Device Access | 9 Participants |
Primary
Number of Participants With Successful Study Device Deployment
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.
Time frame: During treatment procedure (day 0)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Branched TAG® Device | Number of Participants With Successful Study Device Deployment | 9 Participants |
Secondary
Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab
Time frame: 1 Month
Population: One participant not assessed for patency at 1 month.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Branched TAG® Device | Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab | 8 Participants |
Secondary
Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab
Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (Type IA or IB) or the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (Type III).
Time frame: 1 Month
Population: Two participants not assessed for endoleaks at 1 month.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Branched TAG® Device | Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab | 7 Participants |