Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Abdominal Aortic Aneurysm |
Device: Vascutek Anaconda™ Stent Graft System |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair |
- Evaluation of graft performance [ Time Frame: 60 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Data will be collected and analysed on endoleak exclusion and graft migration rates
- Exclusion of aneurysm [ Time Frame: 60 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2005 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Abdominal Aortic Aneurysm | Device: Vascutek Anaconda™ Stent Graft System |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients implanted with a CE-Marked Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Inclusion Criteria:
- Patient is implanted with Anaconda™ Stent Graft System
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
Contacts and Locations| Australia, New South Wales | |
| Dalcross Private Hospital | Recruiting |
| Killara, New South Wales, Australia, 2071 | |
| Contact: Dr Richard Harris (02) 9932 6600 | |
| Principal Investigator: Dr Richard Harris | |
| Newcastle Private Medical Suites | Recruiting |
| Newcastle, New South Wales, Australia, NSW 2305 | |
| Contact: Dr Paul Myers (02) 4952 5911 | |
| Principal Investigator: Dr Paul Myers | |
| Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Dr John Fletcher (02)9845 5555 | |
| Principal Investigator: Dr John Fletcher | |
| Australia, Victoria | |
| The Austin Hospital | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Contact: Dr Gary Fell (03)9496 5000 | |
| Principal Investigator: Dr Gary Fell | |
| Australia | |
| Geelong Regional Vascular Service | Recruiting |
| Geelong, Australia, 3220 | |
| Contact: Dr David Neale McClure (03) 5229 0024 | |
| Principal Investigator: Dr David Neale McClure | |
| Royal Perth Hospital | Recruiting |
| Perth, Australia, 6000 | |
| Contact: Dr Bibombe Patrice Mwipatayi (08)9224 2244 | |
| Principal Investigator: Dr Bibombe Patrice Mwipatayi | |
| Hollywood, Royal Perth | Recruiting |
| Perth, Australia, WA 6000 | |
| Contact: Dr Kishore Sieunarine (08)9224 2244 | |
| Principal Investigator: Dr Kishore Sieunarine | |
| France | |
| Clinique Guillaume De Varye | Recruiting |
| Saint Doulchard, France, 18230 | |
| Contact: Dr Olivier Briand 0826 39 99 08 | |
| Contact: Dr Darrieus | |
| Principal Investigator: Dr Olivier Briand | |
| Sub-Investigator: Dr Darrieus | |
| Germany | |
| DRK Kliniken Mark Brandenburg | Recruiting |
| Berlin, Germany, 13359 | |
| Contact: Dr Ingo Flessenkaemper 030 30356001 | |
| Principal Investigator: Dr Ingo Flessenkaemper | |
| Dresden-Friedrichstadt | Recruiting |
| Dresden, Germany, 0167 | |
| Contact: Dr Hans Florek 0351 480-0 | |
| Principal Investigator: Dr Hans Florek | |
| Klinikum Grosshadern | Recruiting |
| Munich, Germany, 81377 | |
| Contact: Dr Reinhard Kopp 089 5160-0 | |
| Principal Investigator: Dr Reinhard Kopp | |
| Italy | |
| San Orsola - Bologna University | Recruiting |
| Bologna, Italy | |
| Contact: Dr Antonio Freyrie +39 051 2099507 | |
| Principal Investigator: Dr Antonio Freyrie | |
| University federico II | Recruiting |
| Naples, Italy, 80138 | |
| Contact: Dr Giancarlo Bracale 081 676799 | |
| Principal Investigator: Dr Giancarlo Bracale | |
| Guglielmo da Saliceto | Recruiting |
| Piacenza, Italy | |
| Contact: Dr Ugo Ugolotti 0523 302366 | |
| Principal Investigator: Dr Ugo Ugolotti | |
| Casa di Cura Nuova Itor | Recruiting |
| Roma, Italy, 00158 | |
| Contact: Dr Sante Camilli 06 416021 | |
| Principal Investigator: Dr Sante Camilli | |
| New Zealand | |
| Christchurch Hospital, CDHB | Recruiting |
| Christchurch, New Zealand, 8011 | |
| Contact: Dr David Lewis (03) 364 0640 | |
| Principal Investigator: Dr David Lewis | |
| Waikato Hospital | Recruiting |
| Hamilton, New Zealand, 3204 | |
| Contact: Dr Thodur Vasudevan (07) 839 8899 | |
| Principal Investigator: Dr Thodur Vasudevan | |
| Spain | |
| Hospital Universitario Madrid Monteprincipe | Recruiting |
| Madrid, Spain, 28660 | |
| Contact: Dr Luis Izquierdo Lamoca 917 08 99 00 | |
| Principal Investigator: Dr Luis Izquierdo Lamoca | |
| United Kingdom | |
| Royal Derby Hospital | Recruiting |
| Derby, United Kingdom, DE22 3NE | |
| Contact: Dr Peter Bungay 01332 340131 | |
| Principal Investigator: Dr Peter Bungay | |
| Gartnavel General Hospital | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Contact: Dr Richard Edwards 0141 211 3000 | |
| Principal Investigator: Dr Richard Edwards | |
| Wishaw General Hospital | Recruiting |
| Wishaw, United Kingdom, ML2 0DP | |
| Contact: Dr Donald Reid 01698 361100 | |
| Principal Investigator: Dr Donald Reid | |
More Information
No publications provided
| Responsible Party: | Vascutek Ltd. |
| ClinicalTrials.gov Identifier: | NCT01744119 History of Changes |
| Other Study ID Numbers: | ANA-PMS001 |
| Study First Received: | November 29, 2012 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United Kingdom: National Health Service |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013