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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01744119




Registration number
NCT01744119
Ethics application status
Date submitted
29/11/2012
Date registered
6/12/2012
Date last updated
24/05/2016

Titles & IDs
Public title
Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry
Scientific title
Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Secondary ID [1] 0 0
ANA-PMS001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Abdominal Aortic Aneurysm -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of graft performance
Timepoint [1] 0 0
60 months
Primary outcome [2] 0 0
Graft patency
Timepoint [2] 0 0
60 months
Primary outcome [3] 0 0
Exclusion of aneurysm
Timepoint [3] 0 0
60 months

Eligibility
Key inclusion criteria
* Patient is implanted with Anaconda™ Stent Graft System
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ruptured or symptomatic aneurysm
* Juxta or Suprarenal extension of aneurysm
* Clinically serious concomitant medical disease or infection
* Need to sacrifice both Internal Iliac Arteries due to aneurysmal dilatation
* Connective Tissue Disease (Marfan's Syndrome)
* ASA Rating of Grade IV or V
* Known allergy to Nitinol, Polyester or contrast medium
* Excessive tortuosity of access vessels (femoral or iliac arteries)
* Patients with aneurysm neck lengths of less than 15mm

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
318
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Dalcross Private Hospital - Killara
Recruitment hospital [2] 0 0
Newcastle Private Medical Suites - Newcastle
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
The Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Geelong Regional Vascular Service - Geelong
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 0 0
Hollywood, Royal Perth - Perth
Recruitment postcode(s) [1] 0 0
2071 - Killara
Recruitment postcode(s) [2] 0 0
NSW 2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
WA 6000 - Perth
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Saint Doulchard
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Dresden
Country [4] 0 0
Germany
State/province [4] 0 0
Munich
Country [5] 0 0
Italy
State/province [5] 0 0
Bologna
Country [6] 0 0
Italy
State/province [6] 0 0
Naples
Country [7] 0 0
Italy
State/province [7] 0 0
Piacenza
Country [8] 0 0
Italy
State/province [8] 0 0
Roma
Country [9] 0 0
New Zealand
State/province [9] 0 0
Christchurch
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Derby
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Glasgow
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Wishaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vascutek Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01744119