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.
Detailed description
For Zone 0/1, there are two arms (Aneurysm arm, Non-aneurysm arm) and three cohorts, described as follows: Zone 0/1 Aneurysm, Zone 0/1 Dissection, and Zone 0/1 Other Isolated Lesion. The Zone 0/1 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 0/1 Subjects enrolled for analysis were from the United States and Japan.
Interventions
Endovascular repair with the TBE Device
PROCEDURERevascularization Procedure
Revascularization procedure of the great vessel
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. 8. Native aortic valve (Zone 0/1 subjects only) 9. Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)
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 26. Patient at high risk of neurological event, e.g. stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1 | 1 month | Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis. |
| Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1 | 12 months | Primary Endpoint was composite of the following events from the time of enrollment through twelve months following the endovascular procedure: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis. |
Countries
Japan, United States
Contacts
PRINCIPAL_INVESTIGATORMichael Dake, MD
Stanford University
PRINCIPAL_INVESTIGATORHimanshu Patel, MD
University of Michigan
Participant flow
Pre-assignment details
The study enrolled participants into 2 Zones (7 total cohorts) and results are reported by zone. This record (NCT02777528) contains the results for the 3 cohorts of Zone 0/1 (Zone 0/1 Aneurysm Cohort, Zone 0/1 Dissection Cohort, Zone 0/1 Other Isolated Lesion Cohort). Results for the 4 cohorts of Zone 2 (Zone 2 Aneurysm Cohort, Zone 2 Dissection Cohort, Zone 2 Other Lesions Cohort, Zone 2 Traumatic Transection Cohort) are reported in a separate record (NCT02777593).
Participants by arm
| Arm | Count |
|---|---|
| Zone 0/1 Aneurysm Cohort Aneurysm arm, hypothesis-driven cohort | 50 |
| Zone 0/1 Dissection Cohort Non-aneurysm arm, dissection cohort | 24 |
| Zone 0/1 Other Isolated Lesion Cohort Non-aneurysm arm, other isolated lesion cohort | 3 |
| Total | 77 |
Baseline characteristics
| Characteristic | Zone 0/1 Aneurysm Cohort | Total | Zone 0/1 Other Isolated Lesion Cohort | Zone 0/1 Dissection Cohort |
|---|---|---|---|---|
| Age, Continuous | 74.3 years STANDARD_DEVIATION 8.56 | 70.8 years STANDARD_DEVIATION 10.75 | 73.7 years STANDARD_DEVIATION 9.02 | 63.0 years STANDARD_DEVIATION 11.31 |
| BMI | 27.3 kg/m^2 STANDARD_DEVIATION 5.94 | 27.9 kg/m^2 STANDARD_DEVIATION 5.57 | 23.4 kg/m^2 STANDARD_DEVIATION 2.01 | 29.9 kg/m^2 STANDARD_DEVIATION 4.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 73 Participants | 3 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants | 18 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 12 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Hawaiian or Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 27 Participants | 43 Participants | 3 Participants | 13 Participants |
| Region of Enrollment Japan | 10 participants | 11 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 40 participants | 66 participants | 3 participants | 23 participants |
| Sex: Female, Male Female | 18 Participants | 26 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 32 Participants | 51 Participants | 2 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 14 / 52 | 7 / 24 | 1 / 3 |
| other Total, other adverse events | 40 / 52 | 21 / 24 | 2 / 3 |
| serious Total, serious adverse events | 43 / 52 | 19 / 24 | 1 / 3 |
Outcome results
Primary
Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1
Primary Endpoint was composite of the following events from the time of enrollment through twelve months following the endovascular procedure: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or 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 Zone 0/1 Aneurysm participants that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified, due to treatment with 49/53 devices no longer supported by the protocol.~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 0/1 Aneurysm Cohort | Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1 | 0.727 proportion of participants |
| Zone 0/1 Dissection Cohort | Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1 | 0.750 proportion of participants |
| Zone 0/1 Other Isolated Lesion Cohort | Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1 | 1.0 proportion of participants |
Primary
Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1
Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Time frame: 1 month
Population: Two Zone 0/1 Aneurysm participants that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified due to treatment with 49/53 mm devices no longer supported by the protocol.~Primary Endpoint composite denominator was restricted to number of participants either with a primary endpoint event or imaging performed in the 1 Month window.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zone 0/1 Aneurysm Cohort | Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1 | 0.745 proportion of participants |
| Zone 0/1 Dissection Cohort | Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1 | 0.818 proportion of participants |
| Zone 0/1 Other Isolated Lesion Cohort | Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1 | 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 1-Month imaging performed.~Results were tested against a performance goal (PG) of 0.60 (i.e. 60%), derived from outcomes from a systematic review of hybrid TEVAR repair literature.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 50 patients.