Trial Outcomes & Findings for Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection (NCT NCT00917852)
NCT ID: NCT00917852
Last Updated: 2017-08-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
30 days post-treatment
Results posted on
2017-08-25
Participant Flow
Participant milestones
| Measure |
GORE Conformable TAG® Device Surgical Implant
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
GORE Conformable TAG® Device Surgical Implant
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
Baseline characteristics by cohort
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=51 Participants
|
|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 19.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 days post-treatmentPopulation: All enrolled subjects
Outcome measures
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=51 Participants
|
|---|---|
|
All Cause Mortality
|
4 participants
|
PRIMARY outcome
Timeframe: 1 month post-treatmentMajor device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.
Outcome measures
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=51 Participants
|
|---|---|
|
Major Device Events
|
0 Participants
|
Adverse Events
CTAG Device Trauma Subjects
Serious events: 27 serious events
Other events: 48 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
CTAG Device Trauma Subjects
n=51 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
2/51 • 5 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.0%
1/51 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/51 • 5 years
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Aortic valve incompetence
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
2/51 • 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/51 • 5 years
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Haematemesis
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
5.9%
3/51 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • 5 years
|
|
General disorders
Complication associated with device
|
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
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Cellulitis
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Endocarditis
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Enterococcal infection
|
3.9%
2/51 • 5 years
|
|
Infections and infestations
Pneumonia
|
3.9%
2/51 • 5 years
|
|
Infections and infestations
Postoperative wound infection
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Pyelonephritis
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Septic shock
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Skin infection
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Wound infection
|
2.0%
1/51 • 5 years
|
|
Infections and infestations
Wound infection staphylococcal
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Fat embolism
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
3.9%
2/51 • 5 years
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Splenic injury
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
2.0%
1/51 • 5 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.0%
1/51 • 5 years
|
|
Investigations
Blood culture positive
|
2.0%
1/51 • 5 years
|
|
Investigations
Haematocrit decreased
|
2.0%
1/51 • 5 years
|
|
Investigations
Heart rate increased
|
2.0%
1/51 • 5 years
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
2.0%
1/51 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
1/51 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
1/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
2.0%
1/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
3.9%
2/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
2.0%
1/51 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
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)
Metastasis
|
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)
Neoplasm malignant
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Cerebral hypoperfusion
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Hyponatraemic seizure
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
2.0%
1/51 • 5 years
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
1/51 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
2.0%
1/51 • 5 years
|
|
Renal and urinary disorders
Anuria
|
3.9%
2/51 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.9%
2/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.9%
2/51 • 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
Respiratory distress
|
3.9%
2/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.9%
3/51 • 5 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.0%
1/51 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Haemodynamic instability
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Hypotension
|
5.9%
3/51 • 5 years
|
|
Vascular disorders
Intermittent claudication
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Shock
|
2.0%
1/51 • 5 years
|
|
Vascular disorders
Shock haemorrhagic
|
2.0%
1/51 • 5 years
|
Other adverse events
| Measure |
CTAG Device Trauma Subjects
n=51 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.6%
10/51 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
3/51 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
15.7%
8/51 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
3/51 • 5 years
|
|
Cardiac disorders
Tachycardia
|
17.6%
9/51 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
5.9%
3/51 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
5/51 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
3/51 • 5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
3/51 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
11.8%
6/51 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • 5 years
|
|
General disorders
Fatigue
|
7.8%
4/51 • 5 years
|
|
General disorders
Generalised oedema
|
5.9%
3/51 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
7.8%
4/51 • 5 years
|
|
General disorders
Oedema peripheral
|
15.7%
8/51 • 5 years
|
|
General disorders
Pyrexia
|
19.6%
10/51 • 5 years
|
|
Infections and infestations
Pneumonia
|
13.7%
7/51 • 5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
3/51 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
13.7%
7/51 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.8%
4/51 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.8%
5/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
6/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
6/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
5.9%
3/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
3/51 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
3/51 • 5 years
|
|
Nervous system disorders
Headache
|
13.7%
7/51 • 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
9.8%
5/51 • 5 years
|
|
Nervous system disorders
Paraesthesia
|
7.8%
4/51 • 5 years
|
|
Psychiatric disorders
Anxiety
|
7.8%
4/51 • 5 years
|
|
Psychiatric disorders
Depression
|
9.8%
5/51 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
5.9%
3/51 • 5 years
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
5.9%
3/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
17.6%
9/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.9%
3/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.8%
5/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
3/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
37.3%
19/51 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
11.8%
6/51 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
5.9%
3/51 • 5 years
|
|
Vascular disorders
Hypertension
|
13.7%
7/51 • 5 years
|
|
Vascular disorders
Hypotension
|
5.9%
3/51 • 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