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Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

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ClinicalTrials.gov Identifier: NCT00908388
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : May 16, 2014
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type B Aortic Dissection
Intervention Device: GORE TAG® Thoracic Endoprosthesis
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 50
Completed 40
Not Completed 10
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
57.1  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
13
  26.0%
Male
37
  74.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title All-cause Mortality Incidence Through 30 Days Post-treatment
Hide Description [Not Specified]
Time Frame 30 Days Post-Treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description:
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 Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GORE Conformable TAG® Device Surgical Implant
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments (1-Posterior probability of meeting performance goal given the data)
Method Bayesian adaptive
Comments [Not Specified]
2.Primary Outcome
Title Exclusion of Primary Entry Tear
Hide Description Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description:
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 Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
39
3.Secondary Outcome
Title False Lumen Thrombosis
Hide Description Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.
Time Frame Last available follow-up through 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description:
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 Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
Complete Thrombosis 38
Partial Thrombosis 6
Unknown 1
4.Secondary Outcome
Title Aortic Rupture
Hide Description Number of participants with thoracic aortic rupture
Time Frame Last available follow-up through 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description:
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 Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
2
5.Secondary Outcome
Title Additional Dissection Based Intervention Rate
Hide Description Number 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.
Time Frame Last available follow-up through 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description:
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 Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
9
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
GORE Conformable TAG® Device Surgical Implant
Affected / at Risk (%)
Total   13/50 (26.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GORE Conformable TAG® Device Surgical Implant
Affected / at Risk (%)
Total   38/50 (76.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  3/50 (6.00%) 
Disseminated intravascular coagulation * 1  1/50 (2.00%) 
Febrile neutropenia * 1  1/50 (2.00%) 
Leukocytosis * 1  1/50 (2.00%) 
Pancytopenia * 1  1/50 (2.00%) 
Cardiac disorders   
Acute myocardial infarction * 1  3/50 (6.00%) 
Angina pectoris * 1  6/50 (12.00%) 
Atrial fibrillation * 1  2/50 (4.00%) 
Cardiac arrest * 1  2/50 (4.00%) 
Cardiac failure * 1  1/50 (2.00%) 
Cardiac failure acute * 1  1/50 (2.00%) 
Cardiac failure congestive * 1  3/50 (6.00%) 
Cardio-respiratory arrest * 1  2/50 (4.00%) 
Cardiogenic shock * 1  1/50 (2.00%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/50 (2.00%) 
Abdominal hernia * 1  1/50 (2.00%) 
Abdominal pain * 1  3/50 (6.00%) 
Constipation * 1  1/50 (2.00%) 
Functional gastrointestinal disorder * 1  1/50 (2.00%) 
Gastrointestinal haemorrhage * 1  1/50 (2.00%) 
Gastrointestinal necrosis * 1  2/50 (4.00%) 
Haematemesis * 1  1/50 (2.00%) 
Ileus * 1  2/50 (4.00%) 
Lower gastrointestinal haemorrhage * 1  1/50 (2.00%) 
Nausea * 1  1/50 (2.00%) 
Pancreatitis * 1  1/50 (2.00%) 
Peptic ulcer * 1  1/50 (2.00%) 
Small intestinal obstruction * 1  2/50 (4.00%) 
Upper gastrointestinal haemorrhage * 1  1/50 (2.00%) 
Vomiting * 1  2/50 (4.00%) 
General disorders   
Complication of device removal * 1  1/50 (2.00%) 
Multiple organ dysfunction syndrome * 1  1/50 (2.00%) 
Non-cardiac chest pain * 1  1/50 (2.00%) 
Pyrexia * 1  4/50 (8.00%) 
Stent-graft endoleak * 1  6/50 (12.00%) 
Hepatobiliary disorders   
Ischaemic hepatitis * 1  1/50 (2.00%) 
Infections and infestations   
Abdominal wall abscess * 1  1/50 (2.00%) 
Arthritis infective * 1  1/50 (2.00%) 
Bacteraemia * 1  1/50 (2.00%) 
Gastroenteritis * 1  1/50 (2.00%) 
Groin infection * 1  1/50 (2.00%) 
Infection * 1  1/50 (2.00%) 
Klebsiella infection * 1  1/50 (2.00%) 
Pneumonia * 1  1/50 (2.00%) 
Pneumonia pseudomonal * 1  1/50 (2.00%) 
Sepsis * 1  2/50 (4.00%) 
Urinary tract infection * 1  3/50 (6.00%) 
Injury, poisoning and procedural complications   
Incision site oedema * 1  1/50 (2.00%) 
Incision site pain * 1  1/50 (2.00%) 
Lumbar vertebral fracture * 1  1/50 (2.00%) 
Postoperative ileus * 1  2/50 (4.00%) 
Vascular pseudoaneurysm * 1  1/50 (2.00%) 
Investigations   
Troponin increased * 1  1/50 (2.00%) 
White blood cell count increased * 1  2/50 (4.00%) 
Metabolism and nutrition disorders   
Diabetic ketoacidosis * 1  1/50 (2.00%) 
Gout * 1  1/50 (2.00%) 
Hypocalcaemia * 1  1/50 (2.00%) 
Lactic acidosis * 1  1/50 (2.00%) 
Metabolic acidosis * 1  1/50 (2.00%) 
Obesity * 1  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/50 (4.00%) 
Compartment syndrome * 1  1/50 (2.00%) 
Haemarthrosis * 1  1/50 (2.00%) 
Lumbar spinal stenosis * 1  1/50 (2.00%) 
Muscular weakness * 1  1/50 (2.00%) 
Osteoarthritis * 1  1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung cancer metastatic * 1  1/50 (2.00%) 
Renal cell carcinoma * 1  1/50 (2.00%) 
Nervous system disorders   
Alcoholic seizure * 1  1/50 (2.00%) 
Basal ganglia infarction * 1  1/50 (2.00%) 
Brain injury * 1  1/50 (2.00%) 
Brain oedema * 1  1/50 (2.00%) 
Carotid artery dissection * 1  1/50 (2.00%) 
Carotid artery occlusion * 1  1/50 (2.00%) 
Cerebral ischaemia * 1  1/50 (2.00%) 
Cerebrovascular accident * 1  4/50 (8.00%) 
Encephalopathy * 1  1/50 (2.00%) 
Ischaemic stroke * 1  1/50 (2.00%) 
Monoplegia * 1  1/50 (2.00%) 
Paraesthesia * 1  1/50 (2.00%) 
Paraparesis * 1  1/50 (2.00%) 
Seizure * 1  1/50 (2.00%) 
Spinal cord infarction * 1  1/50 (2.00%) 
Spinal cord ischaemia * 1  2/50 (4.00%) 
Syncope * 1  1/50 (2.00%) 
Unresponsive to stimuli * 1  1/50 (2.00%) 
Psychiatric disorders   
Delirium * 1  1/50 (2.00%) 
Delirium tremens * 1  1/50 (2.00%) 
Depression * 1  1/50 (2.00%) 
Mental status changes * 1  1/50 (2.00%) 
Suicide attempt * 1  1/50 (2.00%) 
Renal and urinary disorders   
Acute kidney injury * 1  5/50 (10.00%) 
Anuria * 1  1/50 (2.00%) 
Chronic kidney disease * 1  1/50 (2.00%) 
Renal artery stenosis * 1  1/50 (2.00%) 
Renal atrophy * 1  1/50 (2.00%) 
Renal failure * 1  1/50 (2.00%) 
Renal impairment * 1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  2/50 (4.00%) 
Acute respiratory failure * 1  2/50 (4.00%) 
Chronic obstructive pulmonary disease * 1  3/50 (6.00%) 
Cystic lung disease * 1  1/50 (2.00%) 
Dyspnoea * 1  1/50 (2.00%) 
Haemothorax * 1  1/50 (2.00%) 
Hypoxia * 1  4/50 (8.00%) 
Pleural effusion * 1  3/50 (6.00%) 
Pneumonitis * 1  2/50 (4.00%) 
Pneumothorax * 1  1/50 (2.00%) 
Pulmonary embolism * 1  1/50 (2.00%) 
Pulmonary hypertension * 1  1/50 (2.00%) 
Pulmonary oedema * 1  1/50 (2.00%) 
Respiratory failure * 1  8/50 (16.00%) 
Vascular disorders   
Accelerated hypertension * 1  1/50 (2.00%) 
Aortic aneurysm * 1  2/50 (4.00%) 
Aortic aneurysm rupture * 1  1/50 (2.00%) 
Aortic dissection * 1  5/50 (10.00%) 
Aortic dissection rupture * 1  1/50 (2.00%) 
Aortic rupture * 1  1/50 (2.00%) 
Deep vein thrombosis * 1  1/50 (2.00%) 
False lumen dilatation of aortic dissection * 1  1/50 (2.00%) 
Haemorrhage * 1  1/50 (2.00%) 
Hypertension * 1  4/50 (8.00%) 
Hypotension * 1  2/50 (4.00%) 
Labile blood pressure * 1  1/50 (2.00%) 
Orthostatic hypotension * 1  1/50 (2.00%) 
Peripheral artery stenosis * 1  1/50 (2.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GORE Conformable TAG® Device Surgical Implant
Affected / at Risk (%)
Total   42/50 (84.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  10/50 (20.00%) 
Leukocytosis * 1  4/50 (8.00%) 
Thrombocytopenia * 1  5/50 (10.00%) 
Cardiac disorders   
Angina pectoris * 1  5/50 (10.00%) 
Atrial fibrillation * 1  6/50 (12.00%) 
Bradycardia * 1  3/50 (6.00%) 
Cardiac failure congestive * 1  3/50 (6.00%) 
Pericardial effusion * 1  3/50 (6.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  7/50 (14.00%) 
Abdominal pain upper * 1  3/50 (6.00%) 
Ascites * 1  3/50 (6.00%) 
Constipation * 1  4/50 (8.00%) 
Diarrhoea * 1  5/50 (10.00%) 
Dysphagia * 1  3/50 (6.00%) 
Nausea * 1  9/50 (18.00%) 
Vomiting * 1  3/50 (6.00%) 
General disorders   
Asthenia * 1  3/50 (6.00%) 
Non-cardiac chest pain * 1  3/50 (6.00%) 
Oedema peripheral * 1  8/50 (16.00%) 
Peripheral swelling * 1  3/50 (6.00%) 
Pyrexia * 1  8/50 (16.00%) 
Stent-graft endoleak * 1  6/50 (12.00%) 
Infections and infestations   
Cellulitis * 1  3/50 (6.00%) 
Urinary tract infection * 1  8/50 (16.00%) 
Injury, poisoning and procedural complications   
Device deployment issue * 1  3/50 (6.00%) 
Investigations   
Blood creatinine increased * 1  4/50 (8.00%) 
Metabolism and nutrition disorders   
Hyperglycaemia * 1  3/50 (6.00%) 
Hypernatraemia * 1  3/50 (6.00%) 
Hypokalaemia * 1  4/50 (8.00%) 
Hyponatraemia * 1  4/50 (8.00%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  8/50 (16.00%) 
Muscular weakness * 1  3/50 (6.00%) 
Pain in extremity * 1  7/50 (14.00%) 
Nervous system disorders   
Headache * 1  5/50 (10.00%) 
Hypoaesthesia * 1  3/50 (6.00%) 
Paraesthesia * 1  5/50 (10.00%) 
Psychiatric disorders   
Depression * 1  3/50 (6.00%) 
Mental status changes * 1  3/50 (6.00%) 
Renal and urinary disorders   
Renal failure * 1  3/50 (6.00%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis * 1  13/50 (26.00%) 
Pleural effusion * 1  23/50 (46.00%) 
Pulmonary oedema * 1  4/50 (8.00%) 
Vascular disorders   
Haematoma * 1  3/50 (6.00%) 
Hypertension * 1  4/50 (8.00%) 
Hypotension * 1  7/50 (14.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Abe Letter
Organization: W.L. Gore & Associates
Phone: 928-864-3113
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00908388     History of Changes
Other Study ID Numbers: TAG 08-01
First Submitted: April 3, 2009
First Posted: May 25, 2009
Results First Submitted: October 24, 2013
Results First Posted: May 16, 2014
Last Update Posted: October 27, 2017