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Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection

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: NCT00917852
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : May 1, 2012
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 Thoracic Injuries
Intervention Device: Gore Conformable TAG Thoracic Endoprosthesis
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 51
Completed 45
Not Completed 6
Reason Not Completed
Death             6
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description [Not Specified]
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
44.1  (19.9)
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 All Cause Mortality
Hide Description [Not Specified]
Time Frame 30 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title GORE Conformable TAG® Device Surgical Implant
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
4
2.Primary Outcome
Title Major Device Events
Hide Description Major 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.
Time Frame 1 month post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE Conformable TAG® Thoracic Endoprosthesis
Hide Arm/Group Description:
Gore Conformable TAG Thoracic Endoprosthesis: Endovascular stent graft
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CTAG Device Trauma Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
CTAG Device Trauma Subjects
Affected / at Risk (%)
Total   7/51 (13.73%) 
Hide Serious Adverse Events
CTAG Device Trauma Subjects
Affected / at Risk (%)
Total   27/51 (52.94%) 
Blood and lymphatic system disorders   
Anaemia * 1  2/51 (3.92%) 
Iron deficiency anaemia * 1  1/51 (1.96%) 
Leukocytosis * 1  1/51 (1.96%) 
Splenic haemorrhage * 1  1/51 (1.96%) 
Cardiac disorders   
Angina pectoris * 1  1/51 (1.96%) 
Aortic valve incompetence * 1  1/51 (1.96%) 
Atrial fibrillation * 1  2/51 (3.92%) 
Cardio-respiratory arrest * 1  1/51 (1.96%) 
Pericardial effusion * 1  1/51 (1.96%) 
Supraventricular tachycardia * 1  1/51 (1.96%) 
Tachycardia * 1  1/51 (1.96%) 
Gastrointestinal disorders   
Ascites * 1  1/51 (1.96%) 
Colitis * 1  1/51 (1.96%) 
Haematemesis * 1  1/51 (1.96%) 
Ileus * 1  3/51 (5.88%) 
Nausea * 1  1/51 (1.96%) 
Vomiting * 1  1/51 (1.96%) 
General disorders   
Complication associated with device * 1  1/51 (1.96%) 
Non-cardiac chest pain * 1  1/51 (1.96%) 
Pyrexia * 1  2/51 (3.92%) 
Hepatobiliary disorders   
Cholecystitis * 1  1/51 (1.96%) 
Infections and infestations   
Cellulitis * 1  1/51 (1.96%) 
Endocarditis * 1  1/51 (1.96%) 
Enterococcal infection * 1  2/51 (3.92%) 
Pneumonia * 1  2/51 (3.92%) 
Postoperative wound infection * 1  1/51 (1.96%) 
Pyelonephritis * 1  1/51 (1.96%) 
Respiratory tract infection * 1  1/51 (1.96%) 
Septic shock * 1  1/51 (1.96%) 
Skin infection * 1  1/51 (1.96%) 
Wound infection * 1  1/51 (1.96%) 
Wound infection staphylococcal * 1  1/51 (1.96%) 
Injury, poisoning and procedural complications   
Craniocerebral injury * 1  1/51 (1.96%) 
Fat embolism * 1  1/51 (1.96%) 
Femur fracture * 1  2/51 (3.92%) 
Gastrostomy tube site complication * 1  1/51 (1.96%) 
Splenic injury * 1  1/51 (1.96%) 
Toxicity to various agents * 1  1/51 (1.96%) 
Traumatic liver injury * 1  1/51 (1.96%) 
Wound dehiscence * 1  1/51 (1.96%) 
Investigations   
Blood culture positive * 1  1/51 (1.96%) 
Haematocrit decreased * 1  1/51 (1.96%) 
Heart rate increased * 1  1/51 (1.96%) 
Metabolism and nutrition disorders   
Abnormal weight gain * 1  1/51 (1.96%) 
Hyperkalaemia * 1  1/51 (1.96%) 
Hyponatraemia * 1  1/51 (1.96%) 
Musculoskeletal and connective tissue disorders   
Compartment syndrome * 1  1/51 (1.96%) 
Fracture nonunion * 1  2/51 (3.92%) 
Joint contracture * 1  1/51 (1.96%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute promyelocytic leukaemia * 1  1/51 (1.96%) 
Lung adenocarcinoma * 1  1/51 (1.96%) 
Lung adenocarcinoma recurrent * 1  1/51 (1.96%) 
Lung neoplasm malignant * 1  1/51 (1.96%) 
Metastasis * 1  1/51 (1.96%) 
Metastatic neoplasm * 1  1/51 (1.96%) 
Neoplasm malignant * 1  1/51 (1.96%) 
Nervous system disorders   
Cerebral hypoperfusion * 1  1/51 (1.96%) 
Cerebrovascular accident * 1  1/51 (1.96%) 
Headache * 1  1/51 (1.96%) 
Hyponatraemic seizure * 1  1/51 (1.96%) 
Hypoxic-ischaemic encephalopathy * 1  1/51 (1.96%) 
Ischaemic stroke * 1  1/51 (1.96%) 
Psychiatric disorders   
Mental status changes * 1  1/51 (1.96%) 
Renal and urinary disorders   
Anuria * 1  2/51 (3.92%) 
Renal failure * 1  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  1/51 (1.96%) 
Acute respiratory failure * 1  2/51 (3.92%) 
Dyspnoea * 1  1/51 (1.96%) 
Hypoxia * 1  2/51 (3.92%) 
Pleural effusion * 1  3/51 (5.88%) 
Pneumothorax * 1  1/51 (1.96%) 
Respiratory distress * 1  2/51 (3.92%) 
Respiratory failure * 1  3/51 (5.88%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/51 (1.96%) 
Skin ulcer * 1  1/51 (1.96%) 
Vascular disorders   
Haemodynamic instability * 1  1/51 (1.96%) 
Hypotension * 1  3/51 (5.88%) 
Intermittent claudication * 1  1/51 (1.96%) 
Shock * 1  1/51 (1.96%) 
Shock haemorrhagic * 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 Trauma Subjects
Affected / at Risk (%)
Total   48/51 (94.12%) 
Blood and lymphatic system disorders   
Anaemia * 1  10/51 (19.61%) 
Leukocytosis * 1  3/51 (5.88%) 
Cardiac disorders   
Angina pectoris * 1  8/51 (15.69%) 
Atrial fibrillation * 1  3/51 (5.88%) 
Tachycardia * 1  9/51 (17.65%) 
Gastrointestinal disorders   
Constipation * 1  3/51 (5.88%) 
Diarrhoea * 1  5/51 (9.80%) 
Dysphagia * 1  3/51 (5.88%) 
Gastrooesophageal reflux disease * 1  3/51 (5.88%) 
Nausea * 1  6/51 (11.76%) 
Vomiting * 1  3/51 (5.88%) 
General disorders   
Fatigue * 1  4/51 (7.84%) 
Generalised oedema * 1  3/51 (5.88%) 
Non-cardiac chest pain * 1  4/51 (7.84%) 
Oedema peripheral * 1  8/51 (15.69%) 
Pyrexia * 1  10/51 (19.61%) 
Infections and infestations   
Pneumonia * 1  7/51 (13.73%) 
Upper respiratory tract infection * 1  3/51 (5.88%) 
Urinary tract infection * 1  7/51 (13.73%) 
Metabolism and nutrition disorders   
Hypokalaemia * 1  4/51 (7.84%) 
Hyponatraemia * 1  5/51 (9.80%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  6/51 (11.76%) 
Back pain * 1  6/51 (11.76%) 
Joint effusion * 1  3/51 (5.88%) 
Muscle spasms * 1  3/51 (5.88%) 
Pain in extremity * 1  3/51 (5.88%) 
Nervous system disorders   
Headache * 1  7/51 (13.73%) 
Hypoaesthesia * 1  5/51 (9.80%) 
Paraesthesia * 1  4/51 (7.84%) 
Psychiatric disorders   
Anxiety * 1  4/51 (7.84%) 
Depression * 1  5/51 (9.80%) 
Mental status changes * 1  3/51 (5.88%) 
Post-traumatic stress disorder * 1  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis * 1  9/51 (17.65%) 
Dysphonia * 1  3/51 (5.88%) 
Dyspnoea * 1  5/51 (9.80%) 
Hypoxia * 1  3/51 (5.88%) 
Pleural effusion * 1  19/51 (37.25%) 
Pneumothorax * 1  6/51 (11.76%) 
Vascular disorders   
Deep vein thrombosis * 1  3/51 (5.88%) 
Hypertension * 1  7/51 (13.73%) 
Hypotension * 1  3/51 (5.88%) 
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: NCT00917852    
Other Study ID Numbers: TAG 08-02
First Submitted: June 8, 2009
First Posted: June 10, 2009
Results First Submitted: April 4, 2012
Results First Posted: May 1, 2012
Last Update Posted: August 25, 2017