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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00526487




Registration number
NCT00526487
Ethics application status
Date submitted
5/09/2007
Date registered
10/09/2007
Date last updated
1/03/2017

Titles & IDs
Public title
Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection
Scientific title
Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta
Secondary ID [1] 0 0
370010, TXD
Secondary ID [2] 0 0
07-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Dissection Involving the Descending Thoracic Aorta 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Zenith® Dissection Endovascular System
Treatment: Devices - Endovascular Repair

Other: 1 - Endovascular Repair


Treatment: Devices: Zenith® Dissection Endovascular System
The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Treatment: Devices: Endovascular Repair
Endovascular Repair
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint is survival at 30 days
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* Branch vessel obstruction/compromise
* Peri-aortic effusion/hematoma
* Resistant hypertension
* Persistent pain/symptoms
* Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age less than 18 years
* Frank rupture
* Diagnosed or suspected congenital degenerative connective tissue disease
* Systemic infection
* Untreatable reaction to contrast
* Surgical/endovascular AAA repair within 30 days
* Previous placement of thoracic endovascular graft
* Prior repair of descending thoracic aorta
* Interventional/open procedures within 30 days
* Onset of symptoms > 3 months

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
VIC 3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Brno
Country [2] 0 0
France
State/province [2] 0 0
Cedex
Country [3] 0 0
Germany
State/province [3] 0 0
Hannover
Country [4] 0 0
Germany
State/province [4] 0 0
Leipzig
Country [5] 0 0
Germany
State/province [5] 0 0
Rostock
Country [6] 0 0
Italy
State/province [6] 0 0
Milan
Country [7] 0 0
Italy
State/province [7] 0 0
Pavia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
William Cook Europe
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Cook Group Incorporated
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
MED Institute, Incorporated
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
William Cook Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.
Trial website
https://clinicaltrials.gov/study/NCT00526487
Trial related presentations / publications
Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.
Public notes

Contacts
Principal investigator
Name 0 0
Joseph Lombardi, MD
Address 0 0
Thomas Jefferson University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00526487