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TRANSFIX Zenith® Transection Clinical Study (TRANSFIX)

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: NCT01688050
Recruitment Status : Completed
First Posted : September 19, 2012
Results First Posted : November 18, 2015
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Thoracic Aorta
Thoracic Injuries
Blunt Injuries
Intervention Device: Zenith® TX2® Low Profile Endovascular Graft
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Endovascular Repair
Hide Arm/Group Description Zenith® TX2® Low Profile Endovascular Graft
Period Title: Overall Study
Started 50
5-Year 22 [1]
Completed 19
Not Completed 31
Reason Not Completed
Death             7
Conversion to open repair             1
Lost to Follow-up             13
Withdrawal by Subject             10
[1]
Patients eligible for Follow-up at 5 year
Arm/Group Title Endovascular Repair
Hide Arm/Group Description Zenith® TX2® Low Profile Endovascular Graft
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
42.7  (18.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
6
  12.0%
Male
44
  88.0%
1.Primary Outcome
Title All-cause Mortality
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
One death was adjudicated as unrelated by the Clinical Events Committee (CEC).
Arm/Group Title Endovascular Repair
Hide Arm/Group Description:
Zenith® TX2® Low Profile Endovascular Graft
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Repair
Comments [Not Specified]
Type of Statistical Test Other
Comments The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference
Method of Estimation Estimation Parameter All-cause mortality rate (%)
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
0 to 5.88
Estimation Comments Wald method
2.Primary Outcome
Title Aortic Injury-related Mortality
Hide Description Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Repair
Hide Arm/Group Description:
Zenith® TX2® Low Profile Endovascular Graft
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Repair
Comments [Not Specified]
Type of Statistical Test Other
Comments The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference
Method of Estimation Estimation Parameter Aortic injury-related mortality rate (%)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 7.1
Estimation Comments Exact method
3.Primary Outcome
Title Device Success
Hide Description Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient had device compression (counted as a failure conservatively although the compression was not consistent with collapse of the proximal end of the device) and one patient had a site-reported Type I endoleak requiring secondary intervention.
Arm/Group Title Endovascular Repair
Hide Arm/Group Description:
Zenith® TX2® Low Profile Endovascular Graft
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
48
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Repair
Comments [Not Specified]
Type of Statistical Test Other
Comments The primary effectiveness endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference
Method of Estimation Estimation Parameter Device success rate (%)
Estimated Value 96.0
Confidence Interval (2-Sided) 95%
90.6 to 100
Estimation Comments Wald method
Time Frame 5-Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endovascular Repair
Hide Arm/Group Description Zenith® TX2® Low Profile Endovascular Graft
All-Cause Mortality
Endovascular Repair
Affected / at Risk (%)
Total   7/50 (14.00%)    
Hide Serious Adverse Events
Endovascular Repair
Affected / at Risk (%) # Events
Total   30/50 (60.00%)    
Blood and lymphatic system disorders   
Anaemia  1  2/50 (4.00%)  3
Cardiac disorders   
Arrhythmia  1  3/50 (6.00%)  3
Cardiac arrest  1  2/50 (4.00%)  2
Cardiomyopathy  1  1/50 (2.00%)  1
Pericardial effusion  1  1/50 (2.00%)  1
Gastrointestinal disorders   
Aorto-oesophageal fistula  1  1/50 (2.00%)  1
Gastrointestinal haemorrhage  1  1/50 (2.00%)  1
Intestinal Obstruction  1  2/50 (4.00%)  2
Dental caries  1  1/50 (2.00%)  1
Gastroesophageal reflux disease  1  1/50 (2.00%)  1
Impaired gastric emptying  1  1/50 (2.00%)  1
General disorders   
Multiple organ dysfunction  1  3/50 (6.00%)  3
Systemic inflammatory response syndrome  1  1/50 (2.00%)  1
Infections and infestations   
Gastrointestinal infection  1  1/50 (2.00%)  1
Pneumonia  1  9/50 (18.00%)  10
Urinary Tract Infection  1  2/50 (4.00%)  3
Abscess limb  1  1/50 (2.00%)  1
Bacteraemia  1  1/50 (2.00%)  1
CNS ventriculitis  1  1/50 (2.00%)  1
Groin infection  1  1/50 (2.00%)  1
Pancreatic abscess  1  1/50 (2.00%)  1
Sepsis  1  2/50 (4.00%)  3
Tooth abscess  1  1/50 (2.00%)  1
Injury, poisoning and procedural complications   
Limb injury  1 [1]  1/50 (2.00%)  1
Postoperative wound complication  1  1/50 (2.00%)  2
Subdural Haematoma  1  1/50 (2.00%)  1
Vascular Pseudoaneurysm  1  4/50 (8.00%)  5
Vascular injury  1  1/50 (2.00%)  1
Vascular access site complication  1  1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders   
Osteonecrosis  1  1/50 (2.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer metastatic  1  1/50 (2.00%)  1
Nervous system disorders   
Cerebrovascular accident  1 [2]  1/50 (2.00%)  1
Carotid artery dissection  1  1/50 (2.00%)  1
Hydrocephalus  1  1/50 (2.00%)  1
Quadriplegia  1  1/50 (2.00%)  1
Product Issues   
Device failure  1  1/50 (2.00%)  1
Psychiatric disorders   
Psychotic disorder  1  1/50 (2.00%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/50 (2.00%)  1
Renal failure  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/50 (2.00%)  1
Aspiration  1  1/50 (2.00%)  1
Respiratory distress  1  1/50 (2.00%)  1
Vocal cord disorder  1  1/50 (2.00%)  1
Acute respiratory distress syndrome  1  3/50 (6.00%)  3
Haemothroax  1  1/50 (2.00%)  1
Pleural effusion  1  1/50 (2.00%)  2
Pneumothorax  1  1/50 (2.00%)  2
Pulmonary embolism  1  2/50 (4.00%)  2
Skin and subcutaneous tissue disorders   
Diabetic foot  1  1/50 (2.00%)  1
Surgical and medical procedures   
Cholecystectomy  1  1/50 (2.00%)  1
Hip Disarticulation  1 [3]  1/50 (2.00%)  1
Hip arthroplasty  1 [4]  1/50 (2.00%)  1
Withdrawal of life support  1  1/50 (2.00%)  1
Vascular disorders   
Aortic dissection  1  1/50 (2.00%)  1
Deep vein thrombosis  1  2/50 (4.00%)  2
Haematoma  1  1/50 (2.00%)  1
Hypotension  1 [5]  1/50 (2.00%)  1
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
[1]
Right Labral tear s/p fall down 3-4 stairs while carrying boxes/moving 07-01-2016 Right hip replacement 7-10-2016
[2]
One additional stroke event was reported. However, per evaluation by the site, the event was not considered to be a serious adverse event. Therefore, it is not present in this table
[3]
Extremity left hip disarticulation wound infection: infected hematoma and necrotic muscle
[4]
orthopaedic surgery (hip replacement and plate removal from tibia)
[5]
Hypotension secondary to nausea/vomiting and dehydration
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Endovascular Repair
Affected / at Risk (%) # Events
Total   21/50 (42.00%)    
Cardiac disorders   
Arrhythmia  1  4/50 (8.00%)  4
General disorders   
Non-cardiac chest pain  1  3/50 (6.00%)  3
Vascular stent thrombosis  1  4/50 (8.00%)  4
Infections and infestations   
Pneumonia  1  8/50 (16.00%)  8
Urinary tract infection  1  5/50 (10.00%)  7
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  3/50 (6.00%)  3
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  3/50 (6.00%)  3
Vascular disorders   
Deep vein thrombosis  1  4/50 (8.00%)  5
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alan Saunders,MS, RAC; Manager, Biostatistics
Organization: Cook Research Incorporated
Phone: 765-463-7537 ext 321204
EMail: Alan.Saunders@CookMedical.com
Layout table for additonal information
Responsible Party: Cook Group Incorporated ( Cook Research Incorporated )
ClinicalTrials.gov Identifier: NCT01688050    
Other Study ID Numbers: 11-004
First Submitted: September 14, 2012
First Posted: September 19, 2012
Results First Submitted: October 15, 2015
Results First Posted: November 18, 2015
Last Update Posted: November 18, 2020