Abdominal Aortic AneurysmNCT01744119
Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry
An observational study of Abdominal Aortic Aneurysm, run by Vascutek Ltd. at 21 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Vascutek Anaconda™ Stent Graft System
- Type of treatment
- Medical device
- How many people
- 318 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Apr 2005to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with a CE-Marked Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Who may be able to join
- Patient is implanted with Anaconda™ Stent Graft System
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
Australia7 sites
Geelong Regional Vascular Service
Geelong, 3220
The Austin Hospital
Heidelberg, Victoria, 3084
Dalcross Private Hospital
Killara, New South Wales, 2071
Newcastle Private Medical Suites
Newcastle, New South Wales, NSW 2305
Royal Perth Hospital
Perth, 6000
Hollywood, Royal Perth
Perth, WA 6000
Westmead Hospital
Westmead, New South Wales, 2145
Italy4 sites
San Orsola - Bologna University
Bologna
University federico II
Naples, 80138
Guglielmo da Saliceto
Piacenza
Casa di Cura Nuova Itor
Roma, 00158
Germany3 sites
DRK Kliniken Mark Brandenburg
Berlin, 13359
Dresden-Friedrichstadt
Dresden, 0167
Klinikum Grosshadern
Munich, 81377
United Kingdom3 sites
Royal Derby Hospital
Derby, DE22 3NE
Gartnavel General Hospital
Glasgow, G12 0YN
Wishaw General Hospital
Wishaw, ML2 0DP
New Zealand2 sites
Christchurch Hospital, CDHB
Christchurch, 8011
Waikato Hospital
Hamilton, 3204
About this study
Official title: Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
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.
Read the detailed description
Vascutek Limited, a world leader in the development of vascular grafts, has combined their latest technological developments in polyester textile technology with unique endovascular design features to produce Anaconda™, the world's next generation of AAA stent graft systems. Intuitive and of a modular design, Anaconda™ is the only repositionable device which also features exceptional flexibility. The modular design comprises bifurcate bodies, iliac legs and aortic cuffs. Nitinol, an alloy of nickel and titanium, has self-expanding properties and forms the top "ring-stent" of the bifurcate body section. The "ring stent" is composed of multiple turns of Nitinol wire that provides significantly increased "hoop-strength" enabling a conformable and secure haemostatic seal against the vessel wall to be achieved. Nitinol hooks located adjacent to the "ring stent" anchor the graft in position thus preventing graft migration. The iliac limbs are fully supported with Nitinol and the bifurcate bodies feature a distal contra-lateral lumen Nitinol support, which in conjunction with a unique intrinsic magnet guidewire system facilitates cannulation of the bifurcate section.
The system is available in a wide range of sizes thus making it a flexible and adaptable stent graft system with the potential to repair diverse patient anatomy.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Vascutek Anaconda™ Stent Graft System
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascutek Anaconda™ Stent Graft SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Aortic Aneurysm | Not described Receives: Device: Vascutek Anaconda™ Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 months
Graft patency
Data will be collected and analysed on endoleak exclusion and graft migration rates
Measured: 60 months
Exclusion of aneurysm
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startApr 2005
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744119
- Sponsor's protocol ID
- ANA-PMS001
- Status last verified
- May 2016
- First submitted
- 29 Nov 2012
- Last updated
- 24 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT01744119
- Acronym / sponsor ID
- ANA-PMS001
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vascutek Limited, a world leader in the development of vascular grafts, has combined their latest technological developments in polyester textile technology with unique endovascular design features to produce Anaconda™, the world's next generation of AAA stent graft systems. Intuitive and of a modular design, Anaconda™ is the only repositionable device which also features exceptional flexibility. The modular design comprises bifurcate bodies, iliac legs and aortic cuffs. Nitinol, an alloy of nickel and titanium, has self-expanding properties and forms the top "ring-stent" of the bifurcate body section. The "ring stent" is composed of multiple turns of Nitinol wire that provides significantly increased "hoop-strength" enabling a conformable and secure haemostatic seal against the vessel wall to be achieved. Nitinol hooks located adjacent to the "ring stent" anchor the graft in position thus preventing graft migration. The iliac limbs are fully supported with Nitinol and the bifurcate bodies feature a distal contra-lateral lumen Nitinol support, which in conjunction with a unique intrinsic magnet guidewire system facilitates cannulation of the bifurcate section.
The system is available in a wide range of sizes thus making it a flexible and adaptable stent graft system with the potential to repair diverse patient anatomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Aortic Aneurysm | – | Device: Vascutek Anaconda™ Stent Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a CE-Marked Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Key inclusion criteria (1 listed)
- Patient is implanted with Anaconda™ Stent Graft System
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascutek Anaconda™ Stent Graft System | Device | Abdominal Aortic Aneurysm |
Primary outcome
Evaluation of graft performance
Time frame: 60 months
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.
Graft patency
Time frame: 60 months
Data will be collected and analysed on endoleak exclusion and graft migration rates
Exclusion of aneurysm
Time frame: 60 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Vascutek Ltd. at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Australia, Italy, Germany, United Kingdom, New Zealand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of graft performance (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.