Trial Outcomes & Findings for Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic (NCT NCT00874250)
NCT ID: NCT00874250
Last Updated: 2017-08-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Treatment through 1 month post treatment
Results posted on
2017-08-25
Participant Flow
Participant milestones
| Measure |
GORE CTAG Device
The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
Baseline characteristics by cohort
| Measure |
GORE CTAG Device
n=51 Participants
The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
|
|---|---|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 9.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Treatment through 1 month post treatmentOutcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
|
50 participants
Interval 50.0 to 50.0
|
SECONDARY outcome
Timeframe: Treatment through 1 month post procedureOutcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
|
13 participants
|
SECONDARY outcome
Timeframe: Initial Device Implant Procedure During Index HospitalizationTotal time in minutes required for surgical device implantation.
Outcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
Procedure Time (Minutes)
|
118 Minutes
Interval 109.5 to 140.4
|
SECONDARY outcome
Timeframe: Initial Device Implant Procedure During Index HospitalizationBlood loss in mL during initial device implantation procedure
Outcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
Operative Blood Loss (mL)
|
150 mL
Standard Deviation 403.5
|
SECONDARY outcome
Timeframe: During the Index HospitalizationConvalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation
Outcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
Days of Convalescence Stay in an Intensive Care Unit
|
38 participants
|
SECONDARY outcome
Timeframe: Total Duration of the Index HospitalizationTotal days of hospital stay during the initial hospitalization for implantation of device
Outcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
Total Length of Hospital Stay (Days)
|
4 Days
Interval 1.0 to 68.0
|
SECONDARY outcome
Timeframe: Average time within one month windowThis is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.
Outcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=47 Participants
|
|---|---|
|
Time in Days to Return to Normal Daily Activities
|
31 Days
Interval 3.0 to 374.0
|
SECONDARY outcome
Timeframe: Initial Device Implant Procedure During Index HospitalizationSubjects who survived the index procedure
Outcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
Procedural Survival
|
51 Participants
|
SECONDARY outcome
Timeframe: Initial Device Implant Index HospitalizationSubjects admitted to ICU during index hospitalization
Outcome measures
| Measure |
CTAG Device Aneurysym Subjects
n=51 Participants
|
|---|---|
|
Intensive Care Unit (ICU) Stay
|
38 Participants
|
Adverse Events
CTAG Device Aneurysm Subjects
Serious events: 37 serious events
Other events: 42 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
CTAG Device Aneurysm Subjects
n=51 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
5/51 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
9.8%
5/51 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
3.9%
2/51 • 5 years
|
|
Cardiac disorders
Angina unstable
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
7.8%
4/51 • 5 years
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Atrioventricular block
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Bradycardia
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
3.9%
2/51 • 5 years
|
|
Cardiac disorders
Cardiac failure
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
5.9%
3/51 • 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Coronary artery disease
|
3.9%
2/51 • 5 years
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
7.8%
4/51 • 5 years
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.9%
2/51 • 5 years
|
|
Gastrointestinal disorders
Haematemesis
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Neurogenic bowel
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Odynophagia
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • 5 years
|
|
General disorders
Asthenia
|
3.9%
2/51 • 5 years
|
|
General disorders
Multimorbidity
|
2.0%
1/51 • 5 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.0%
1/51 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/51 • 5 years
|
|
General disorders
Pyrexia
|
3.9%
2/51 • 5 years
|
|
General disorders
Stent-graft endoleak
|
2.0%
1/51 • 5 years
|
|
Hepatobiliary disorders
Cholangitis acute
|
2.0%
1/51 • 5 years
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Diverticulitis
|
3.9%
2/51 • 5 years
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Necrotising fasciitis
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Pneumonia
|
15.7%
8/51 • 5 years
|
|
Infections and infestations
Sepsis
|
3.9%
2/51 • 5 years
|
|
Infections and infestations
Sepsis syndrome
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
7.8%
4/51 • 5 years
|
|
Injury, poisoning and procedural complications
Arterial injury
|
3.9%
2/51 • 5 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
2.0%
1/51 • 5 years
|
|
Investigations
International normalised ratio increased
|
2.0%
1/51 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
1/51 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.9%
2/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
3.9%
2/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage I
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
5.9%
3/51 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Spinal cord disorder
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Spinal cord ischaemia
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Spinal epidural haematoma
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Vocal cord paralysis
|
2.0%
1/51 • 5 years
|
|
Psychiatric disorders
Confusional state
|
2.0%
1/51 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
3.9%
2/51 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
9.8%
5/51 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.9%
3/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
3/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.9%
2/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.8%
4/51 • 5 years
|
|
Vascular disorders
Accelerated hypertension
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Aortic aneurysm
|
5.9%
3/51 • 5 years
|
|
Vascular disorders
Aortic aneurysm rupture
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Aortic dissection rupture
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Aortic stenosis
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Haematoma
|
3.9%
2/51 • 5 years
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • 5 years
|
|
Vascular disorders
Hypoperfusion
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Iliac artery occlusion
|
3.9%
2/51 • 5 years
|
|
Vascular disorders
Peripheral artery aneurysm
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Peripheral artery thrombosis
|
2.0%
1/51 • 5 years
|
Other adverse events
| Measure |
CTAG Device Aneurysm Subjects
n=51 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.3%
18/51 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
3/51 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
5.9%
3/51 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
15.7%
8/51 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
5.9%
3/51 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
13.7%
7/51 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
7.8%
4/51 • 5 years
|
|
General disorders
Chest pain
|
5.9%
3/51 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
7.8%
4/51 • 5 years
|
|
General disorders
Oedema peripheral
|
9.8%
5/51 • 5 years
|
|
General disorders
Stent-graft endoleak
|
19.6%
10/51 • 5 years
|
|
Infections and infestations
Bronchitis
|
5.9%
3/51 • 5 years
|
|
Infections and infestations
Pneumonia
|
7.8%
4/51 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
13.7%
7/51 • 5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
7.8%
4/51 • 5 years
|
|
Injury, poisoning and procedural complications
Incision site pain
|
9.8%
5/51 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.8%
6/51 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
3/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.7%
8/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
3/51 • 5 years
|
|
Nervous system disorders
Dizziness
|
5.9%
3/51 • 5 years
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • 5 years
|
|
Nervous system disorders
Paraesthesia
|
5.9%
3/51 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
5.9%
3/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
15.7%
8/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
3/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.8%
4/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
19.6%
10/51 • 5 years
|
|
Vascular disorders
Aortic aneurysm
|
5.9%
3/51 • 5 years
|
|
Vascular disorders
Haematoma
|
9.8%
5/51 • 5 years
|
|
Vascular disorders
Hypertension
|
13.7%
7/51 • 5 years
|
|
Vascular disorders
Hypotension
|
17.6%
9/51 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER