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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
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Secondary ID [1]
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ANA-PMS001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Vascutek Anaconda™ Stent Graft System
Abdominal Aortic Aneurysm -
Treatment: Devices: Vascutek Anaconda™ Stent Graft System
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Evaluation of graft performance
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Assessment method [1]
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Data will be collected and analysed on system insertion and difficulty during deployment. Efficiency of the magnet system including magnet selection, ease of use and removal of magnet guidewire will also be evaluated.
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Timepoint [1]
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60 months
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Primary outcome [2]
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Graft patency
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Assessment method [2]
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Data will be collected and analysed on endoleak exclusion and graft migration rates
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Timepoint [2]
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60 months
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Primary outcome [3]
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Exclusion of aneurysm
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Assessment method [3]
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Timepoint [3]
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60 months
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Eligibility
Key inclusion criteria
- Patient is implanted with Anaconda™ Stent Graft System
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2016
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Sample size
Target
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Accrual to date
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Final
318
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Dalcross Private Hospital - Killara
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Recruitment hospital [2]
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Newcastle Private Medical Suites - Newcastle
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment hospital [4]
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The Austin Hospital - Heidelberg
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Recruitment hospital [5]
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Geelong Regional Vascular Service - Geelong
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Recruitment hospital [6]
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Royal Perth Hospital - Perth
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Recruitment hospital [7]
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Hollywood, Royal Perth - Perth
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Recruitment postcode(s) [1]
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2071 - Killara
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Recruitment postcode(s) [2]
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NSW 2305 - Newcastle
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment postcode(s) [6]
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6000 - Perth
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Recruitment postcode(s) [7]
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WA 6000 - Perth
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Saint Doulchard
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Munich
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Italy
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Bologna
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Italy
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Naples
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Italy
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State/province [7]
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Piacenza
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Italy
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Roma
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Country [9]
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New Zealand
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State/province [9]
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Christchurch
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New Zealand
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Hamilton
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Spain
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Madrid
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United Kingdom
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Derby
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United Kingdom
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Glasgow
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United Kingdom
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State/province [14]
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Wishaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vascutek Ltd.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this observational Post-Market Surveillance Registry is to gather post-market
data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair
of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for
endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60
months post-implantation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01744119
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01744119
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