Thoracoabdominal Aortic Aneurysm
Conditions
Brief summary
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
Detailed description
This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.
Interventions
Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
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. Aortic aneurysm involving the visceral vessels requiring treatment 2. Adequate access for TAMBE Device components 3. Appropriate aortic anatomy to receive the TAMBE Device 4. Age ≥ 18 years at the time of informed consent signature 5. Male or infertile female 6. The patient is considered high risk for open repair as deemed by the treating physician 7. Capable of complying with protocol requirements, including follow-up 8. An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply
Exclusion criteria
1. Prior aortic surgery 2. Ruptured or leaking aortic aneurysm 3. Aneurysmal dilatation due to chronic aortic dissection 4. Infected aorta 5. Mycotic aneurysm 6. Life expectancy \<2 years 7. Myocardial infarction or stroke within 6 weeks of treatment 8. Systemic infection which may increase risk of endovascular graft infection 9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 10. Participation in another drug or medical device study within 1 year of study enrollment 11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment 12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access 13. Known sensitivities or allergies to the device materials 14. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 15. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta 16. Renal Insufficiency Note: Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL | Absence of procedural safety events through 30 days post procedure | Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success, Including Individual Components of Technical Success | 12-month | Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure |
| Device Integrity, Including Individual Components of Device Integrity | 12-month | Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components |
| Patency (Primary, Assisted Primary, and Secondary) | 12-month | Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass. |
| Absence of Type I and Type III Endoleaks at One Month Follow-up | One Month followup | Absence of Type I and Type III endoleaks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAMBE Device Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled.
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | TAMBE Device |
|---|---|
| Age, Continuous | 70.2 Years STANDARD_DEVIATION 7.13 |
| Body Mass Index (BMI) | 28.2 kg/m^2 STANDARD_DEVIATION 5.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Height | 174.1 Centimeters (cm) STANDARD_DEVIATION 9.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 86.4 Kilograms (kg) STANDARD_DEVIATION 20.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 10 / 10 |
Outcome results
Primary
Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Time frame: Absence of procedural safety events through 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAMBE Device | Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL | 9 Participants |
Secondary
Absence of Type I and Type III Endoleaks at One Month Follow-up
Absence of Type I and Type III endoleaks
Time frame: One Month followup
Population: Includes only subjects with evaluable imaging within the one month window
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAMBE Device | Absence of Type I and Type III Endoleaks at One Month Follow-up | Absence of Type I Endoleak | 8 Participants |
| TAMBE Device | Absence of Type I and Type III Endoleaks at One Month Follow-up | Absence of Type III Endoleak | 8 Participants |
Secondary
Device Integrity, Including Individual Components of Device Integrity
Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components
Time frame: 12-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAMBE Device | Device Integrity, Including Individual Components of Device Integrity | Loss of Functional Patency (Through 12M) | 2 Participants |
| TAMBE Device | Device Integrity, Including Individual Components of Device Integrity | Separation of Components (Through 12M) | 0 Participants |
Secondary
Patency (Primary, Assisted Primary, and Secondary)
Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.
Time frame: 12-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAMBE Device | Patency (Primary, Assisted Primary, and Secondary) | Primary Patency (Through 12 Months) | 8 Participants |
| TAMBE Device | Patency (Primary, Assisted Primary, and Secondary) | Assisted Primary Patency (Through 12 Months) | 8 Participants |
| TAMBE Device | Patency (Primary, Assisted Primary, and Secondary) | Secondary Patency (Through 12 Months) | 9 Participants |
Secondary
Technical Success, Including Individual Components of Technical Success
Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure
Time frame: 12-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAMBE Device | Technical Success, Including Individual Components of Technical Success | Absence of Surgical Conversion | 10 Participants |
| TAMBE Device | Technical Success, Including Individual Components of Technical Success | Technical Success | 9 Participants |
| TAMBE Device | Technical Success, Including Individual Components of Technical Success | Successful Access | 10 Participants |
| TAMBE Device | Technical Success, Including Individual Components of Technical Success | Successful Deployment | 10 Participants |
| TAMBE Device | Technical Success, Including Individual Components of Technical Success | Patency of all required TAMBE Device components | 9 Participants |