Trial Outcomes & Findings for GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms (NCT NCT02528500)
NCT ID: NCT02528500
Last Updated: 2023-06-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Absence of procedural safety events through 30 days post procedure
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
TAMBE Device
n=10 Participants
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)
|
|---|---|
|
Age, Continuous
|
70.2 Years
STANDARD_DEVIATION 7.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Height
|
174.1 Centimeters (cm)
STANDARD_DEVIATION 9.72 • n=5 Participants
|
|
Weight
|
86.4 Kilograms (kg)
STANDARD_DEVIATION 20.6 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.2 kg/m^2
STANDARD_DEVIATION 5.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: Absence of procedural safety events through 30 days post procedureAbsence 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
Outcome measures
| Measure |
TAMBE Device
n=10 Participants
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)
|
|---|---|
|
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 outcome
Timeframe: 12-monthComponents 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
Outcome measures
| Measure |
TAMBE Device
n=10 Participants
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)
|
|---|---|
|
Technical Success, Including Individual Components of Technical Success
Technical Success
|
9 Participants
|
|
Technical Success, Including Individual Components of Technical Success
Successful Access
|
10 Participants
|
|
Technical Success, Including Individual Components of Technical Success
Successful Deployment
|
10 Participants
|
|
Technical Success, Including Individual Components of Technical Success
Patency of all required TAMBE Device components
|
9 Participants
|
|
Technical Success, Including Individual Components of Technical Success
Absence of Surgical Conversion
|
10 Participants
|
SECONDARY outcome
Timeframe: 12-monthComponents 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
Outcome measures
| Measure |
TAMBE Device
n=10 Participants
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)
|
|---|---|
|
Device Integrity, Including Individual Components of Device Integrity
Loss of Functional Patency (Through 12M)
|
2 Participants
|
|
Device Integrity, Including Individual Components of Device Integrity
Separation of Components (Through 12M)
|
0 Participants
|
SECONDARY outcome
Timeframe: 12-monthPrimary 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.
Outcome measures
| Measure |
TAMBE Device
n=10 Participants
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)
|
|---|---|
|
Patency (Primary, Assisted Primary, and Secondary)
Primary Patency (Through 12 Months)
|
8 Participants
|
|
Patency (Primary, Assisted Primary, and Secondary)
Assisted Primary Patency (Through 12 Months)
|
8 Participants
|
|
Patency (Primary, Assisted Primary, and Secondary)
Secondary Patency (Through 12 Months)
|
9 Participants
|
SECONDARY outcome
Timeframe: One Month followupPopulation: Includes only subjects with evaluable imaging within the one month window
Absence of Type I and Type III endoleaks
Outcome measures
| Measure |
TAMBE Device
n=8 Participants
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)
|
|---|---|
|
Absence of Type I and Type III Endoleaks at One Month Follow-up
Absence of Type I Endoleak
|
8 Participants
|
|
Absence of Type I and Type III Endoleaks at One Month Follow-up
Absence of Type III Endoleak
|
8 Participants
|
Adverse Events
TAMBE Device
Serious events: 10 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
TAMBE Device
n=10 participants at risk
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)
|
|---|---|
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Cardiac disorders
Acute myocardial infarction
|
20.0%
2/10 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Cardiac failure congestive
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Coronary artery disease
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Ventricular fibrillation
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Haematochezia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Illeus
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
General disorders
Vascular stent occlusion
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
General disorders
Vascular stent stenosis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Cystilis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Pyelonephritis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamos cell carcinoma
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Dementia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Parkinson's disease
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Spinal claudication
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
End stage renal disease
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal artery occlusion
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Vascular disorders
Arterial stenosis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Vascular disorders
Artery dissection
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Vascular disorders
Hypertensive urgency
|
10.0%
1/10 • Number of events 1 • 5 Years
|
Other adverse events
| Measure |
TAMBE Device
n=10 participants at risk
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)
|
|---|---|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
20.0%
2/10 • Number of events 2 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • Number of events 3 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 2 • 5 Years
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Hypersomnia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Hypoaesthesia
|
30.0%
3/10 • Number of events 3 • 5 Years
|
|
Nervous system disorders
Seizure
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
2/10 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal atrophy
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal infarct
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Vascular disorders
Peripheral artery thrombosis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Acute myocardial infarction
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Ventricular dyssynchrony
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Ileus paralytic
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
General disorders
Generalised oedema
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
General disorders
Stent-graft endoleak
|
20.0%
2/10 • Number of events 3 • 5 Years
|
|
General disorders
Vascular stent occlusion
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Hordeolum
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Septic Shock
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
10.0%
1/10 • Number of events 1 • 5 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator agree not to submit any Publication until Study Completion and multi-center Publication has been published. If the multi-center Publication has not been submitted within 12 months of Study Completion, Institution and investigator may proceed with submission of the Publication; subject to the following: Investigator will provide all Publications to Sponsor for review that is more than 60 days but may extend an additional 120 days.
- Publication restrictions are in place
Restriction type: OTHER