Aorta; Lesion, Aortic Aneurysm, Thoracic
Conditions
Brief summary
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.
Detailed description
For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 2 Subjects enrolled for analysis were from the United States only.
Interventions
Endovascular repair with the TBE Device
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2. 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. 6. Must have appropriate target branch vessel landing zone 7. For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
Exclusion criteria
1. Concomitant disease of the ascending aorta or aneurysm of the 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 prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access 5. Infected aorta 6. Life expectancy \<2 years 7. Myocardial infarction within 6 weeks prior to treatment 8. Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin. 9. Patient has a systemic infection and may be at increased risk of endovascular graft infection 10. Pregnant female at time of informed consent signature 11. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 12. Participation in another drug or medical device study within one year of study enrollment 13. Known history of drug abuse within one year of treatment 14. Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta 15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access 16. Planned coverage of celiac artery 17. Patient has known sensitivities or allergies to the device materials 18. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment 19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 20. Patient with a history of a hypercoagulability disorder and/or hypercoagulability state 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 25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) \<30 or currently requiring dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Primary Endpoint Success for Zone 2 | 12 Months | Primary Endpoint was composite of the following events: device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device/procedure/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael M Dake, MD
Stanford University
PRINCIPAL_INVESTIGATORHimanshu Patel, MD
University of Michigan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zone 2 Aneurysm Cohort Aneurysm arm, hypothesis-driven cohort | 84 |
| Zone 2 Dissection Cohort Non-aneurysm arm, dissection cohort | 136 |
| Zone 2 Traumatic Transection Cohort Non-aneurysm arm, traumatic transection cohort | 9 |
| Zone 2 Other Isolated Lesion Cohort Non-aneurysm arm, other isolated lesion cohort | 13 |
| Zone 2 Aneurysm Continued Access Aneurysm arm, continued access subjects | 6 |
| Total | 248 |
Baseline characteristics
| Characteristic | Zone 2 Aneurysm Cohort | Zone 2 Dissection Cohort | Zone 2 Traumatic Transection Cohort | Zone 2 Other Isolated Lesion Cohort | Zone 2 Aneurysm Continued Access | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 11.1 | 62.7 years STANDARD_DEVIATION 11.2 | 42.4 years STANDARD_DEVIATION 19 | 64.8 years STANDARD_DEVIATION 13.3 | 59.8 years STANDARD_DEVIATION 15.9 | 64.5 years STANDARD_DEVIATION 12.9 |
| BMI | 28.8 kg/(m^2) STANDARD_DEVIATION 6.3 | 30.6 kg/(m^2) STANDARD_DEVIATION 6.5 | 29.5 kg/(m^2) STANDARD_DEVIATION 5 | 25.8 kg/(m^2) STANDARD_DEVIATION 5.3 | 36.3 kg/(m^2) STANDARD_DEVIATION 8.3 | 29.8 kg/(m^2) STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 4 Participants | 3 Participants | 0 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 127 Participants | 5 Participants | 10 Participants | 6 Participants | 230 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 29 Participants | 0 Participants | 2 Participants | 1 Participants | 44 Participants |
| Race/Ethnicity, Customized Hawaiian or Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 4 Participants | 2 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 67 Participants | 99 Participants | 5 Participants | 9 Participants | 5 Participants | 185 Participants |
| Sex: Female, Male Female | 31 Participants | 33 Participants | 1 Participants | 7 Participants | 3 Participants | 75 Participants |
| Sex: Female, Male Male | 53 Participants | 103 Participants | 8 Participants | 6 Participants | 3 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 21 / 85 | 28 / 136 | 0 / 10 | 5 / 13 | 0 / 6 |
| other Total, other adverse events | 74 / 85 | 111 / 136 | 7 / 10 | 11 / 13 | 4 / 6 |
| serious Total, serious adverse events | 61 / 85 | 99 / 136 | 3 / 10 | 9 / 13 | 4 / 6 |
Outcome results
Primary
Proportion of Participants With Primary Endpoint Success for Zone 2
Primary Endpoint was composite of the following events: device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device/procedure/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Time frame: 12 Months
Population: Two participants (1 Zone 2 Aneurysm and 1 Zone 2 Traumatic Transection) that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified, due to a major I/E violation or an FDA-mandated exclusion.~Primary Endpoint composite denominator was restricted to number of participants either with a primary endpoint event or imaging performed in the 12 Month window.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zone 2 Aneurysm Cohort | Proportion of Participants With Primary Endpoint Success for Zone 2 | 0.838 proportion of participants |
| Zone 2 Dissection Cohort | Proportion of Participants With Primary Endpoint Success for Zone 2 | 0.881 proportion of participants |
| Zone 2 Traumatic Transection Cohort | Proportion of Participants With Primary Endpoint Success for Zone 2 | 1.0 proportion of participants |
| Zone 2 Other Isolated Lesion Cohort | Proportion of Participants With Primary Endpoint Success for Zone 2 | 0.875 proportion of participants |
| Zone 2 Aneurysm Continued Access | Proportion of Participants With Primary Endpoint Success for Zone 2 | 1.0 proportion of participants |
Comparison: Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 12-Month imaging performed.~Results were tested against a performance goal (PG) of 0.64 (i.e. 64%), derived from historical GORE TAG® and Conformable TAG® data.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 70 patients. With attrition, 85 patients were required.