Trial Outcomes & Findings for Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms (NCT NCT02021812)
NCT ID: NCT02021812
Last Updated: 2022-09-09
Results Overview
Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
During treatment procedure (day 0)
Results posted on
2022-09-09
Participant Flow
Participant milestones
| Measure |
Branched TAG® Device
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Branched TAG® Device
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Overall Study
Death
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Refuse to return, COVD 19
|
2
|
Baseline Characteristics
Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
Branched TAG® Device
n=31 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
BMI
|
28.7 kg/(m^2)
STANDARD_DEVIATION 6.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: During treatment procedure (day 0)Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.
Outcome measures
| Measure |
Branched TAG® Device
n=31 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants With Successful Study Device Access
|
31 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Branched TAG® Device
n=31 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants With Successful Study Device Deployment
|
31 Participants
|
PRIMARY outcome
Timeframe: At conclusion of the treatment procedure (day 0)The presence of forward flow through the implanted Side Branch Component into the target branch vessel.
Outcome measures
| Measure |
Branched TAG® Device
n=31 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography
|
31 Participants
|
SECONDARY outcome
Timeframe: 1 MonthOutcome measures
| Measure |
Branched TAG® Device
n=31 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab
|
31 Participants
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: 1 participant was not assessed at 1 Month
Device-related endoelaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the adjacent tissue (endoleak type IA or IB) OR the junction between the Aortic Component and either the SB Component or the Aortic Extender (type III endoleak).
Outcome measures
| Measure |
Branched TAG® Device
n=30 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab
|
29 Participants
|
Adverse Events
Branched TAG® Device
Serious events: 20 serious events
Other events: 30 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Branched TAG® Device
n=31 participants at risk
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Blood and lymphatic system disorders
Acute post hemorrhagic anemia
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
3.2%
1/31 • Number of events 2 • Through 60 Months
|
|
Cardiac disorders
Cardiac arrhythmia
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Cardiac disorders
Chest pain - cardiac
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Cardiac disorders
Congestive heart failure
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Cardiac disorders
Heart block AV first degree
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Cardiac disorders
Systolic heart failure
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Eye disorders
Retinal vein occlusion
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
3.2%
1/31 • Number of events 2 • Through 60 Months
|
|
Gastrointestinal disorders
Ileus
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Gastrointestinal disorders
Inguinal hernia
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Gastrointestinal disorders
Ischemic colitis
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Gastrointestinal disorders
Lower gastrointestinal bleeding
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
General disorders
Adverse drug reaction
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
General disorders
Debility
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
General disorders
Fever
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
General disorders
Unknown cause of death
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Infections and infestations
Aspiration pneumonia
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Infections and infestations
Clostridium difficile infection
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Infections and infestations
Cystitis
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Number of events 3 • Through 60 Months
|
|
Infections and infestations
Urosepsis
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Hematoma traumatic
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Postoperative hypotension
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Procedural hemorrhage
|
3.2%
1/31 • Number of events 2 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Musculoskeletal and connective tissue disorders
Lower extremities weakness of
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc herniation
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Nervous system disorders
CSF leakage
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Nervous system disorders
Cerebrovascular accident
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Nervous system disorders
Paresthesia lower limb
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Nervous system disorders
Stroke
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Product Issues
Device misdeployment (location)
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Psychiatric disorders
Delirium
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Renal and urinary disorders
Renal disease
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory insufficiency
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
|
6.5%
2/31 • Number of events 3 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Ascending aortic aneurysm rupture
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Atherosclerotic cardiovascular disease
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Brachial artery thrombosis
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Hypertension worsened
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Iliac artery dissection
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Leg ischemia
|
3.2%
1/31 • Number of events 1 • Through 60 Months
|
|
Vascular disorders
Peripheral ischemia
|
3.2%
1/31 • Number of events 2 • Through 60 Months
|
Other adverse events
| Measure |
Branched TAG® Device
n=31 participants at risk
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Blood and lymphatic system disorders
Acute post hemorrhagic anemia
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Blood and lymphatic system disorders
Anemia
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.1%
5/31 • Number of events 6 • Through 60 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Cardiac disorders
Sinus tachycardia
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Eye disorders
Macular degeneration
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Gastrointestinal disorders
Constipation
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Gastrointestinal disorders
Diarrhea
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
General disorders
Catheter site pain
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
General disorders
Stent-graft endoleak type IA
|
16.1%
5/31 • Number of events 5 • Through 60 Months
|
|
General disorders
Stent-graft endoleak type II
|
16.1%
5/31 • Number of events 5 • Through 60 Months
|
|
General disorders
Stent-graft endoleak type III
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Infections and infestations
Bronchitis
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Infections and infestations
Urinary tract infection
|
22.6%
7/31 • Number of events 7 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Fall
|
12.9%
4/31 • Number of events 6 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Incision site hematoma
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
12.9%
4/31 • Number of events 5 • Through 60 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
2/31 • Number of events 3 • Through 60 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Nervous system disorders
Dizziness
|
16.1%
5/31 • Number of events 6 • Through 60 Months
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Product Issues
Thrombosis in device
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Psychiatric disorders
Anxiety
|
12.9%
4/31 • Number of events 4 • Through 60 Months
|
|
Psychiatric disorders
Delirium
|
12.9%
4/31 • Number of events 4 • Through 60 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Renal and urinary disorders
Oliguria
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
19.4%
6/31 • Number of events 6 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Basilar atelectasis
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.1%
5/31 • Number of events 5 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.7%
3/31 • Number of events 3 • Through 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Number of events 2 • Through 60 Months
|
|
Vascular disorders
Hypotension
|
19.4%
6/31 • Number of events 7 • Through 60 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place