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Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874250
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : December 13, 2011
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aneurysm
Intervention Device: GORE CTAG Device
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GORE CTAG Device
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 51
Completed 0
Not Completed 51
Arm/Group Title GORE CTAG Device
Hide Arm/Group Description 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 Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
71.9  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
17
  33.3%
Male
34
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
1.Primary Outcome
Title The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
Hide Description [Not Specified]
Time Frame Treatment through 1 month post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTAG Device Aneurysym Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CTAG Device Aneurysym Subjects
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Binomial Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.895 to 0.996
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
Hide Description [Not Specified]
Time Frame Treatment through 1 month post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTAG Device Aneurysym Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
13
3.Secondary Outcome
Title Procedure Time (Minutes)
Hide Description Total time in minutes required for surgical device implantation.
Time Frame Initial Device Implant Procedure During Index Hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTAG Device Aneurysym Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Minutes
118
(109.5 to 140.4)
4.Secondary Outcome
Title Operative Blood Loss (mL)
Hide Description Blood loss in mL during initial device implantation procedure
Time Frame Initial Device Implant Procedure During Index Hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTAG Device Aneurysym Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 51
Median (Standard Deviation)
Unit of Measure: mL
150  (403.5)
5.Secondary Outcome
Title Days of Convalescence Stay in an Intensive Care Unit
Hide Description Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation
Time Frame During the Index Hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTAG Device Aneurysym Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
38
6.Secondary Outcome
Title Total Length of Hospital Stay (Days)
Hide Description Total days of hospital stay during the initial hospitalization for implantation of device
Time Frame Total Duration of the Index Hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTAG Device Aneurysym Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 51
Median (Full Range)
Unit of Measure: Days
4
(1 to 68)
7.Secondary Outcome
Title Time in Days to Return to Normal Daily Activities
Hide Description This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.
Time Frame Average time within one month window
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTAG Device Aneurysym Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Median (Full Range)
Unit of Measure: Days
31
(3 to 374)
8.Secondary Outcome
Title Procedural Survival
Hide Description Subjects who survived the index procedure
Time Frame Initial Device Implant Procedure During Index Hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE CTAG Device
Hide Arm/Group Description:
GORE CTAG Device: Endovascular aortic stent-graft
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
51
 100.0%
9.Secondary Outcome
Title Intensive Care Unit (ICU) Stay
Hide Description Subjects admitted to ICU during index hospitalization
Time Frame Initial Device Implant Index Hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE CTAG Device
Hide Arm/Group Description:
GORE CTAG Device: Endovascular aortic stent-graft
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
38
  74.5%
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CTAG Device Aneurysm Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
CTAG Device Aneurysm Subjects
Affected / at Risk (%)
Total   19/51 (37.25%) 
Hide Serious Adverse Events
CTAG Device Aneurysm Subjects
Affected / at Risk (%)
Total   37/51 (72.55%) 
Blood and lymphatic system disorders   
Anaemia * 1  5/51 (9.80%) 
Neutropenia * 1  1/51 (1.96%) 
Cardiac disorders   
Acute myocardial infarction * 1  5/51 (9.80%) 
Angina pectoris * 1  2/51 (3.92%) 
Angina unstable * 1  1/51 (1.96%) 
Atrial fibrillation * 1  4/51 (7.84%) 
Atrial flutter * 1  1/51 (1.96%) 
Atrioventricular block * 1  1/51 (1.96%) 
Atrioventricular block first degree * 1  1/51 (1.96%) 
Bradycardia * 1  1/51 (1.96%) 
Cardiac arrest * 1  2/51 (3.92%) 
Cardiac failure * 1  1/51 (1.96%) 
Cardiac failure congestive * 1  3/51 (5.88%) 
Cardio-respiratory arrest * 1  1/51 (1.96%) 
Coronary artery disease * 1  2/51 (3.92%) 
Ischaemic cardiomyopathy * 1  1/51 (1.96%) 
Myocardial infarction * 1  4/51 (7.84%) 
Tachycardia * 1  1/51 (1.96%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/51 (1.96%) 
Abdominal pain * 1  1/51 (1.96%) 
Colitis * 1  1/51 (1.96%) 
Diarrhoea * 1  1/51 (1.96%) 
Dysphagia * 1  1/51 (1.96%) 
Gastrointestinal haemorrhage * 1  2/51 (3.92%) 
Haematemesis * 1  1/51 (1.96%) 
Lower gastrointestinal haemorrhage * 1  1/51 (1.96%) 
Neurogenic bowel * 1  1/51 (1.96%) 
Odynophagia * 1  1/51 (1.96%) 
Peritoneal haemorrhage * 1  1/51 (1.96%) 
Vomiting * 1  1/51 (1.96%) 
General disorders   
Asthenia * 1  2/51 (3.92%) 
Multimorbidity * 1  1/51 (1.96%) 
Multiple organ dysfunction syndrome * 1  1/51 (1.96%) 
Non-cardiac chest pain * 1  1/51 (1.96%) 
Pyrexia * 1  2/51 (3.92%) 
Stent-graft endoleak * 1  1/51 (1.96%) 
Hepatobiliary disorders   
Cholangitis acute * 1  1/51 (1.96%) 
Gallbladder necrosis * 1  1/51 (1.96%) 
Infections and infestations   
Diverticulitis * 1  2/51 (3.92%) 
Gastroenteritis * 1  1/51 (1.96%) 
Influenza * 1  1/51 (1.96%) 
Necrotising fasciitis * 1  1/51 (1.96%) 
Pneumonia * 1  8/51 (15.69%) 
Sepsis * 1  2/51 (3.92%) 
Sepsis syndrome * 1  1/51 (1.96%) 
Staphylococcal bacteraemia * 1  1/51 (1.96%) 
Upper respiratory tract infection * 1  1/51 (1.96%) 
Urinary tract infection * 1  4/51 (7.84%) 
Injury, poisoning and procedural complications   
Arterial injury * 1  2/51 (3.92%) 
Femur fracture * 1  1/51 (1.96%) 
Hip fracture * 1  1/51 (1.96%) 
Procedural haemorrhage * 1  1/51 (1.96%) 
Subdural haematoma * 1  1/51 (1.96%) 
Thermal burn * 1  1/51 (1.96%) 
Vascular graft occlusion * 1  1/51 (1.96%) 
Investigations   
International normalised ratio increased * 1  1/51 (1.96%) 
Metabolism and nutrition disorders   
Hyperkalaemia * 1  1/51 (1.96%) 
Hyponatraemia * 1  2/51 (3.92%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/51 (1.96%) 
Muscular weakness * 1  1/51 (1.96%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer recurrent * 1  1/51 (1.96%) 
Breast cancer * 1  2/51 (3.92%) 
Colon neoplasm * 1  1/51 (1.96%) 
Lung carcinoma cell type unspecified stage I * 1  1/51 (1.96%) 
Lung neoplasm malignant * 1  1/51 (1.96%) 
Metastatic neoplasm * 1  1/51 (1.96%) 
Prostate cancer * 1  1/51 (1.96%) 
Prostate cancer metastatic * 1  1/51 (1.96%) 
Salivary gland neoplasm * 1  1/51 (1.96%) 
Ureteral neoplasm * 1  1/51 (1.96%) 
Ureteric cancer * 1  1/51 (1.96%) 
Nervous system disorders   
Cerebrovascular accident * 1  3/51 (5.88%) 
Encephalopathy * 1  1/51 (1.96%) 
Headache * 1  1/51 (1.96%) 
Metabolic encephalopathy * 1  1/51 (1.96%) 
Spinal cord disorder * 1  1/51 (1.96%) 
Spinal cord ischaemia * 1  1/51 (1.96%) 
Spinal epidural haematoma * 1  1/51 (1.96%) 
Vocal cord paralysis * 1  1/51 (1.96%) 
Psychiatric disorders   
Confusional state * 1  1/51 (1.96%) 
Mental status changes * 1  2/51 (3.92%) 
Renal and urinary disorders   
Acute kidney injury * 1  5/51 (9.80%) 
Renal failure * 1  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/51 (1.96%) 
Bronchiectasis * 1  1/51 (1.96%) 
Chronic obstructive pulmonary disease * 1  3/51 (5.88%) 
Chronic respiratory failure * 1  1/51 (1.96%) 
Dyspnoea * 1  1/51 (1.96%) 
Pleural effusion * 1  3/51 (5.88%) 
Pneumothorax * 1  1/51 (1.96%) 
Pulmonary embolism * 1  2/51 (3.92%) 
Respiratory failure * 1  4/51 (7.84%) 
Vascular disorders   
Accelerated hypertension * 1  1/51 (1.96%) 
Aortic aneurysm * 1  3/51 (5.88%) 
Aortic aneurysm rupture * 1  1/51 (1.96%) 
Aortic dissection rupture * 1  1/51 (1.96%) 
Aortic stenosis * 1  1/51 (1.96%) 
Deep vein thrombosis * 1  1/51 (1.96%) 
Haematoma * 1  2/51 (3.92%) 
Hypertension * 1  2/51 (3.92%) 
Hypoperfusion * 1  1/51 (1.96%) 
Hypotension * 1  1/51 (1.96%) 
Iliac artery occlusion * 1  2/51 (3.92%) 
Peripheral artery aneurysm * 1  1/51 (1.96%) 
Peripheral artery thrombosis * 1  1/51 (1.96%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CTAG Device Aneurysm Subjects
Affected / at Risk (%)
Total   42/51 (82.35%) 
Blood and lymphatic system disorders   
Anaemia * 1  18/51 (35.29%) 
Leukocytosis * 1  3/51 (5.88%) 
Cardiac disorders   
Angina pectoris * 1  3/51 (5.88%) 
Atrial fibrillation * 1  8/51 (15.69%) 
Cardiac failure congestive * 1  3/51 (5.88%) 
Gastrointestinal disorders   
Constipation * 1  7/51 (13.73%) 
Nausea * 1  4/51 (7.84%) 
General disorders   
Chest pain * 1  3/51 (5.88%) 
Non-cardiac chest pain * 1  4/51 (7.84%) 
Oedema peripheral * 1  5/51 (9.80%) 
Stent-graft endoleak * 1  10/51 (19.61%) 
Infections and infestations   
Bronchitis * 1  3/51 (5.88%) 
Pneumonia * 1  4/51 (7.84%) 
Urinary tract infection * 1  7/51 (13.73%) 
Injury, poisoning and procedural complications   
Contusion * 1  4/51 (7.84%) 
Incision site pain * 1  5/51 (9.80%) 
Metabolism and nutrition disorders   
Hyperglycaemia * 1  6/51 (11.76%) 
Hyponatraemia * 1  3/51 (5.88%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  8/51 (15.69%) 
Pain in extremity * 1  3/51 (5.88%) 
Nervous system disorders   
Dizziness * 1  3/51 (5.88%) 
Headache * 1  3/51 (5.88%) 
Paraesthesia * 1  3/51 (5.88%) 
Psychiatric disorders   
Mental status changes * 1  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis * 1  8/51 (15.69%) 
Dyspnoea * 1  3/51 (5.88%) 
Epistaxis * 1  4/51 (7.84%) 
Pleural effusion * 1  10/51 (19.61%) 
Vascular disorders   
Aortic aneurysm * 1  3/51 (5.88%) 
Haematoma * 1  5/51 (9.80%) 
Hypertension * 1  7/51 (13.73%) 
Hypotension * 1  9/51 (17.65%) 
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
Layout table for Results Point of Contact information
Name/Title: Abe Letter
Organization: W.L. Gore & Associates
Phone: 928-864-3113
EMail: aletter@wlgore.com
Layout table for additonal information
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00874250    
Other Study ID Numbers: TAG 08-03
First Submitted: March 31, 2009
First Posted: April 2, 2009
Results First Submitted: September 22, 2011
Results First Posted: December 13, 2011
Last Update Posted: August 25, 2017