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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Treatment: Devices - Vascutek Anaconda™ Stent Graft System

Abdominal Aortic Aneurysm -


Treatment: Devices: Vascutek Anaconda™ Stent Graft System


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

Outcomes
Primary outcome [1] 0 0
Evaluation of graft performance - 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.
Timepoint [1] 0 0
60 months
Primary outcome [2] 0 0
Graft patency - Data will be collected and analysed on endoleak exclusion and graft migration rates
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT01744119
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01744119