Trial Outcomes & Findings for Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection (NCT NCT00908388)
NCT ID: NCT00908388
Last Updated: 2017-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
30 Days Post-Treatment
Results posted on
2017-10-27
Participant Flow
Participant milestones
| Measure |
GORE Conformable TAG® Device Surgical Implant
Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
Baseline characteristics by cohort
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=50 Participants
Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
|
|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 Days Post-TreatmentPopulation: All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.
Outcome measures
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=50 Participants
Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
|
|---|---|
|
All-cause Mortality Incidence Through 30 Days Post-treatment
|
5 participants
|
PRIMARY outcome
Timeframe: 1 monthNumber of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery
Outcome measures
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=40 Participants
Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
|
|---|---|
|
Exclusion of Primary Entry Tear
|
39 participants
|
SECONDARY outcome
Timeframe: Last available follow-up through 5 yearsPopulation: Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis
Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.
Outcome measures
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=45 Participants
Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
|
|---|---|
|
False Lumen Thrombosis
Complete Thrombosis
|
38 participants
|
|
False Lumen Thrombosis
Partial Thrombosis
|
6 participants
|
|
False Lumen Thrombosis
Unknown
|
1 participants
|
SECONDARY outcome
Timeframe: Last available follow-up through 5 yearsNumber of participants with thoracic aortic rupture
Outcome measures
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=50 Participants
Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
|
|---|---|
|
Aortic Rupture
|
2 participants
|
SECONDARY outcome
Timeframe: Last available follow-up through 5 yearsNumber of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.
Outcome measures
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=50 Participants
Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
|
|---|---|
|
Additional Dissection Based Intervention Rate
|
9 participants
|
Adverse Events
GORE Conformable TAG® Device Surgical Implant
Serious events: 38 serious events
Other events: 42 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=50 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
3/50 • 5 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.0%
1/50 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/50 • 5 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
1/50 • 5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
6.0%
3/50 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
12.0%
6/50 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
2/50 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
4.0%
2/50 • 5 years
|
|
Cardiac disorders
Cardiac failure
|
2.0%
1/50 • 5 years
|
|
Cardiac disorders
Cardiac failure acute
|
2.0%
1/50 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
6.0%
3/50 • 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
4.0%
2/50 • 5 years
|
|
Cardiac disorders
Cardiogenic shock
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
4.0%
2/50 • 5 years
|
|
Gastrointestinal disorders
Haematemesis
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
4.0%
2/50 • 5 years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Peptic ulcer
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.0%
2/50 • 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • 5 years
|
|
General disorders
Complication of device removal
|
2.0%
1/50 • 5 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.0%
1/50 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • 5 years
|
|
General disorders
Pyrexia
|
8.0%
4/50 • 5 years
|
|
General disorders
Stent-graft endoleak
|
12.0%
6/50 • 5 years
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Abdominal wall abscess
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Arthritis infective
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Bacteraemia
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Groin infection
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Infection
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Klebsiella infection
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Pneumonia pseudomonal
|
2.0%
1/50 • 5 years
|
|
Infections and infestations
Sepsis
|
4.0%
2/50 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
6.0%
3/50 • 5 years
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
2.0%
1/50 • 5 years
|
|
Injury, poisoning and procedural complications
Incision site pain
|
2.0%
1/50 • 5 years
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.0%
1/50 • 5 years
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
4.0%
2/50 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.0%
1/50 • 5 years
|
|
Investigations
Troponin increased
|
2.0%
1/50 • 5 years
|
|
Investigations
White blood cell count increased
|
4.0%
2/50 • 5 years
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.0%
1/50 • 5 years
|
|
Metabolism and nutrition disorders
Gout
|
2.0%
1/50 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
1/50 • 5 years
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
2.0%
1/50 • 5 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.0%
1/50 • 5 years
|
|
Metabolism and nutrition disorders
Obesity
|
2.0%
1/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
2/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
2.0%
1/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
2.0%
1/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
2.0%
1/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/50 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
2.0%
1/50 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Alcoholic seizure
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Basal ganglia infarction
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Brain injury
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Brain oedema
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Carotid artery dissection
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Carotid artery occlusion
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Cerebral ischaemia
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
8.0%
4/50 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Monoplegia
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Paraparesis
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Seizure
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Spinal cord infarction
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Spinal cord ischaemia
|
4.0%
2/50 • 5 years
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Unresponsive to stimuli
|
2.0%
1/50 • 5 years
|
|
Psychiatric disorders
Delirium
|
2.0%
1/50 • 5 years
|
|
Psychiatric disorders
Delirium tremens
|
2.0%
1/50 • 5 years
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
2.0%
1/50 • 5 years
|
|
Psychiatric disorders
Suicide attempt
|
2.0%
1/50 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
5/50 • 5 years
|
|
Renal and urinary disorders
Anuria
|
2.0%
1/50 • 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
1/50 • 5 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.0%
1/50 • 5 years
|
|
Renal and urinary disorders
Renal atrophy
|
2.0%
1/50 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/50 • 5 years
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
4.0%
2/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.0%
2/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.0%
3/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cystic lung disease
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.0%
4/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
3/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
2/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.0%
1/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.0%
8/50 • 5 years
|
|
Vascular disorders
Accelerated hypertension
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Aortic aneurysm
|
4.0%
2/50 • 5 years
|
|
Vascular disorders
Aortic aneurysm rupture
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Aortic dissection
|
10.0%
5/50 • 5 years
|
|
Vascular disorders
Aortic dissection rupture
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Aortic rupture
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
False lumen dilatation of aortic dissection
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Haemorrhage
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Hypertension
|
8.0%
4/50 • 5 years
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • 5 years
|
|
Vascular disorders
Labile blood pressure
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Peripheral artery stenosis
|
2.0%
1/50 • 5 years
|
Other adverse events
| Measure |
GORE Conformable TAG® Device Surgical Implant
n=50 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
10/50 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.0%
4/50 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
5/50 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
10.0%
5/50 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
12.0%
6/50 • 5 years
|
|
Cardiac disorders
Bradycardia
|
6.0%
3/50 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
6.0%
3/50 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
6.0%
3/50 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
7/50 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
3/50 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
6.0%
3/50 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
8.0%
4/50 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
5/50 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
6.0%
3/50 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
18.0%
9/50 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • 5 years
|
|
General disorders
Asthenia
|
6.0%
3/50 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
6.0%
3/50 • 5 years
|
|
General disorders
Oedema peripheral
|
16.0%
8/50 • 5 years
|
|
General disorders
Peripheral swelling
|
6.0%
3/50 • 5 years
|
|
General disorders
Pyrexia
|
16.0%
8/50 • 5 years
|
|
General disorders
Stent-graft endoleak
|
12.0%
6/50 • 5 years
|
|
Infections and infestations
Cellulitis
|
6.0%
3/50 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
16.0%
8/50 • 5 years
|
|
Injury, poisoning and procedural complications
Device deployment issue
|
6.0%
3/50 • 5 years
|
|
Investigations
Blood creatinine increased
|
8.0%
4/50 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.0%
3/50 • 5 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.0%
3/50 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
4/50 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
4/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
8/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.0%
3/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
7/50 • 5 years
|
|
Nervous system disorders
Headache
|
10.0%
5/50 • 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
6.0%
3/50 • 5 years
|
|
Nervous system disorders
Paraesthesia
|
10.0%
5/50 • 5 years
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
6.0%
3/50 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
6.0%
3/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
26.0%
13/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
46.0%
23/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
8.0%
4/50 • 5 years
|
|
Vascular disorders
Haematoma
|
6.0%
3/50 • 5 years
|
|
Vascular disorders
Hypertension
|
8.0%
4/50 • 5 years
|
|
Vascular disorders
Hypotension
|
14.0%
7/50 • 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