TRANSFIX Zenith® Transection Clinical Study | NCT01688050

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Endovascular Repair	Experimental		Device: Zenith® TX2® Low Profile Endovascular Graft

Name	Type	Description	Arm Group Labels	Other Names
Zenith® TX2® Low Profile Endovascular Graft	Device	Treatment of Blunt thoracic aortic injuries (BTAIs)	Endovascular Repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause Mortality		30 days
Aortic Injury-related Mortality	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.	30 days
Device Success	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.	30 days

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Benjamin Starnes, MD	University of Washington - Harborview, Division of Vascular Surgery	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States
Keck Hospital of USC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32014287	Derived	Starnes BW, Dwivedi A, Giglia J, Woo K, Yeh C; TRANSFIX Study Investigators. Updated outcomes from the TRANSFIX study to evaluate endovascular repair of blunt thoracic aortic injuries with the Zenith Alpha thoracic device. J Vasc Surg. 2020 Jun;71(6):1851-1857. doi: 10.1016/j.jvs.2019.05.070. Epub 2020 Feb 1.
26391458	Derived

Results Section

Participant Flow Module

ID	Title	Description
FG000	Endovascular Repair	Zenith® TX2® Low Profile Endovascular Graft

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 14, 2012

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

ID	Title	Description
BG000	Endovascular Repair	Zenith® TX2® Low Profile Endovascular Graft

Units	Counts
Participants	BG00050

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000						All-cause mortality rate (%)	2.0			2-Sided	95	0	5.88			Wald method		Other	The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference

Primary

Aortic Injury-related Mortality

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.

Posted

Number

participants

30 days

ID	Title	Description
OG000	Endovascular Repair	Zenith® TX2® Low Profile Endovascular Graft

Units	Counts
Participants	OG00050

Title	Denominators

Primary

Device Success

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.

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.

Posted

Number

participants

30 days

ID	Title	Description
OG000	Endovascular Repair	Zenith® TX2® Low Profile Endovascular Graft

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Endovascular Repair	Zenith® TX2® Low Profile Endovascular Graft	7	50	30	50	21	50

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment		EG0003 events2 affected50 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.0	Systematic Assessment		EG0003 events3 affected50 at risk
Cardiac arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment		EG0002 events2 affected50 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Aorto-oesophageal fistula	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0002 events2 affected50 at risk
Dental caries	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Multiple organ dysfunction	General disorders	MedDRA 23.0	Systematic Assessment		EG0003 events3 affected50 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG00010 events9 affected50 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0003 events2 affected50 at risk
Abscess limb	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
CNS ventriculitis	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Groin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Pancreatic abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0003 events2 affected50 at risk
Tooth abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	Right Labral tear s/p fall down 3-4 stairs while carrying boxes/moving 07-01-2016 Right hip replacement 7-10-2016	EG0001 events1 affected50 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0002 events1 affected50 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0005 events4 affected50 at risk
Vascular injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	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	EG0001 events1 affected50 at risk
Carotid artery dissection	Nervous system disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Hydrocephalus	Nervous system disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Quadriplegia	Nervous system disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Device failure	Product Issues	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Vocal cord disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0003 events3 affected50 at risk
Haemothroax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0002 events1 affected50 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0002 events1 affected50 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment		EG0002 events2 affected50 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Hip Disarticulation	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	Extremity left hip disarticulation wound infection: infected hematoma and necrotic muscle	EG0001 events1 affected50 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment	orthopaedic surgery (hip replacement and plate removal from tibia)	EG0001 events1 affected50 at risk
Withdrawal of life support	Surgical and medical procedures	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Aortic dissection	Vascular disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment		EG0002 events2 affected50 at risk
Haematoma	Vascular disorders	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	Hypotension secondary to nausea/vomiting and dehydration	EG0001 events1 affected50 at risk
Vascular access site complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment		EG0001 events1 affected50 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected50 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected50 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 events5 affected50 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected50 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected50 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected50 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected50 at risk
Vascular stent thrombosis	General disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected50 at risk

ID	Term
D013898	Thoracic Injuries
D014949	Wounds, Nonpenetrating