Trial Outcomes & Findings for TRANSFIX Zenith® Transection Clinical Study (NCT NCT01688050)
NCT ID: NCT01688050
Last Updated: 2020-11-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
30 days
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
Endovascular Repair
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
5-Year
|
22
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Endovascular Repair
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Conversion to open repair
|
1
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Withdrawal by Subject
|
10
|
Baseline Characteristics
TRANSFIX Zenith® Transection Clinical Study
Baseline characteristics by cohort
| Measure |
Endovascular Repair
n=50 Participants
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 18.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: One death was adjudicated as unrelated by the Clinical Events Committee (CEC).
Outcome measures
| Measure |
Endovascular Repair
n=50 Participants
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
All-cause Mortality
|
1 participants
|
PRIMARY outcome
Timeframe: 30 daysAny 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.
Outcome measures
| Measure |
Endovascular Repair
n=50 Participants
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
Aortic Injury-related Mortality
|
0 participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Endovascular Repair
n=50 Participants
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
Device Success
|
48 participants
|
Adverse Events
Endovascular Repair
Serious events: 30 serious events
Other events: 21 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Endovascular Repair
n=50 participants at risk
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
2/50 • Number of events 3 • 5-Year
|
|
Cardiac disorders
Arrhythmia
|
6.0%
3/50 • Number of events 3 • 5-Year
|
|
Cardiac disorders
Cardiac arrest
|
4.0%
2/50 • Number of events 2 • 5-Year
|
|
Cardiac disorders
Cardiomyopathy
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Aorto-oesophageal fistula
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
4.0%
2/50 • Number of events 2 • 5-Year
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
General disorders
Multiple organ dysfunction
|
6.0%
3/50 • Number of events 3 • 5-Year
|
|
General disorders
Systemic inflammatory response syndrome
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Infections and infestations
Gastrointestinal infection
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Infections and infestations
Pneumonia
|
18.0%
9/50 • Number of events 10 • 5-Year
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
2/50 • Number of events 3 • 5-Year
|
|
Infections and infestations
Abscess limb
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Infections and infestations
Bacteraemia
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Infections and infestations
CNS ventriculitis
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Infections and infestations
Groin infection
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Infections and infestations
Pancreatic abscess
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Infections and infestations
Sepsis
|
4.0%
2/50 • Number of events 3 • 5-Year
|
|
Infections and infestations
Tooth abscess
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
2.0%
1/50 • Number of events 2 • 5-Year
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
8.0%
4/50 • Number of events 5 • 5-Year
|
|
Injury, poisoning and procedural complications
Vascular injury
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Carotid artery dissection
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Hydrocephalus
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Quadriplegia
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Product Issues
Device failure
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Psychiatric disorders
Psychotic disorder
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.0%
3/50 • Number of events 3 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Haemothroax
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Number of events 2 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50 • Number of events 2 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
2/50 • Number of events 2 • 5-Year
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Surgical and medical procedures
Cholecystectomy
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Surgical and medical procedures
Hip Disarticulation
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Surgical and medical procedures
Hip arthroplasty
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Surgical and medical procedures
Withdrawal of life support
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Vascular disorders
Aortic dissection
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
2/50 • Number of events 2 • 5-Year
|
|
Vascular disorders
Haematoma
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
2.0%
1/50 • Number of events 1 • 5-Year
|
Other adverse events
| Measure |
Endovascular Repair
n=50 participants at risk
Zenith® TX2® Low Profile Endovascular Graft
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
8.0%
4/50 • Number of events 4 • 5-Year
|
|
Infections and infestations
Pneumonia
|
16.0%
8/50 • Number of events 8 • 5-Year
|
|
Infections and infestations
Urinary tract infection
|
10.0%
5/50 • Number of events 7 • 5-Year
|
|
Vascular disorders
Deep vein thrombosis
|
8.0%
4/50 • Number of events 5 • 5-Year
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.0%
3/50 • Number of events 3 • 5-Year
|
|
General disorders
Non-cardiac chest pain
|
6.0%
3/50 • Number of events 3 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
3/50 • Number of events 3 • 5-Year
|
|
General disorders
Vascular stent thrombosis
|
8.0%
4/50 • Number of events 4 • 5-Year
|
Additional Information
Alan Saunders,MS, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60