Trial Outcomes & Findings for Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms (NCT NCT02264977)
NCT ID: NCT02264977
Last Updated: 2022-09-14
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
9 participants
Primary outcome timeframe
During treatment procedure (day 0)
Results posted on
2022-09-14
Participant Flow
Participant milestones
| Measure |
Branched TAG® Device
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Branched TAG® Device
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Refuse to return
|
1
|
Baseline Characteristics
Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms
Baseline characteristics by cohort
| Measure |
Branched TAG® Device
n=9 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
BMI, Continuous
|
26.2 kg/(m^2)
STANDARD_DEVIATION 5.5 • n=99 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=9 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants With Successful Study Device Access
|
9 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=9 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants With Successful Study Device Deployment
|
9 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=9 Participants
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Number of Participants With Primary Procedural Side Branch Patency
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: One participant not assessed for patency at 1 month.
Outcome measures
| Measure |
Branched TAG® Device
n=8 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
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: Two participants not assessed for endoleaks at 1 month.
Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (Type IA or IB) or the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (Type III).
Outcome measures
| Measure |
Branched TAG® Device
n=7 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
|
7 Participants
|
Adverse Events
Branched TAG® Device
Serious events: 9 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Branched TAG® Device
n=9 participants at risk
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Bradycardia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Cardiac arrest
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Myocardial infarction
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Pulseless electrical activity
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
ST segment elevation myocardial infarction
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Systolic heart failure
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Congenital, familial and genetic disorders
Hemorrhagic arteriovenous malformation
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Gastrointestinal disorders
Hematemesis
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Physical deconditioning
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Immune system disorders
Anaphylactic reaction
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
COVID-19
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Diverticulitis of colon with hemorrhage
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Mediastinal infection
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Staphylococcal bacteremia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Infections and infestations
Urosepsis
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Viral infection
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture L2
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Musculoskeletal and connective tissue disorders
Pseudogout
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Anoxic encephalopathy
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Arm spasticity
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Cerebral infarction
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Cerebrovascular infarction
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Lacunar infarction
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Middle cerebral artery stroke
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Numbness of lower extremities
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Numbness of upper arm
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Stroke
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Psychiatric disorders
Mental status changes
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
22.2%
2/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Vascular disorders
Deep vein thrombosis leg
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
Other adverse events
| Measure |
Branched TAG® Device
n=9 participants at risk
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Branched TAG® Device
|
|---|---|
|
Blood and lymphatic system disorders
Acute post hemorrhagic anemia
|
22.2%
2/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Cardiac disorders
AV block first degree
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
22.2%
2/9 • Number of events 3 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Left atrial appendage thrombosis
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Mobitz type I
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Right bundle branch block
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
1/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Eye disorders
Transient visual loss
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Gastrointestinal disorders
Ileus
|
22.2%
2/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Chest pain (non-cardiac)
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Fever of unknown origin
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Neck swelling
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
General disorders
Stent-graft endoleak type II
|
22.2%
2/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Infections and infestations
Acute cystitis
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Candidemia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Cellulitis of leg
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Lower urinary tract infection
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Bruise of head
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Chest injury
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Contusion of chest wall
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Contusion of elbow
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Fractured toe
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Laceration of face
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Laceration of wrist
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Neck sprain
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Rib contusion
|
11.1%
1/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
22.2%
2/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Metabolism and nutrition disorders
Gout acute
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Musculoskeletal and connective tissue disorders
Calf pain
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign esophageal neoplasm
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Apraxia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Dizziness exertional
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Embolic cerebral infarction
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Foot drop
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Hemiparesis (right)
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Incoordination
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Numbness in leg
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Paralysis arm
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Parkinson's disease
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Radiculopathy
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Nervous system disorders
Weakness left or right side
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Psychiatric disorders
Agitation
|
22.2%
2/9 • Number of events 2 • From endovascular procedure through 60 months
|
|
Psychiatric disorders
Anxiety depression
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Psychiatric disorders
Delirium
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Renal and urinary disorders
Acute renal failure
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusion
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema pulmonary
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1 • From endovascular procedure through 60 months
|
|
Vascular disorders
Hypotension
|
33.3%
3/9 • Number of events 3 • From endovascular procedure through 60 months
|
|
Vascular disorders
Orthostatic hypotension
|
11.1%
1/9 • Number of events 2 • From endovascular procedure through 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place