Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry

NCT ID: NCT01744119

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Aortic Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abdominal Aortic Aneurysm

Vascutek Anaconda™ Stent Graft System

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vascutek Anaconda™ Stent Graft System

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vascutek Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dalcross Private Hospital

Killara, New South Wales, Australia

Site Status

Newcastle Private Medical Suites

Newcastle, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

The Austin Hospital

Heidelberg, Victoria, Australia

Site Status

Geelong Regional Vascular Service

Geelong, , Australia

Site Status

Royal Perth Hospital

Perth, , Australia

Site Status

Hollywood, Royal Perth

Perth, , Australia

Site Status

Clinique Guillaume De Varye

Saint-Doulchard, , France

Site Status

DRK Kliniken Mark Brandenburg

Berlin, , Germany

Site Status

Dresden-Friedrichstadt

Dresden, , Germany

Site Status

Klinikum Grosshadern

Munich, , Germany

Site Status

San Orsola - Bologna University

Bologna, , Italy

Site Status

University federico II

Naples, , Italy

Site Status

Guglielmo da Saliceto

Piacenza, , Italy

Site Status

Casa di Cura Nuova Itor

Roma, , Italy

Site Status

Christchurch Hospital, CDHB

Christchurch, , New Zealand

Site Status

Waikato Hospital

Hamilton, , New Zealand

Site Status

Hospital Universitario Madrid Monteprincipe

Madrid, , Spain

Site Status

Royal Derby Hospital

Derby, , United Kingdom

Site Status

Gartnavel General Hospital

Glasgow, , United Kingdom

Site Status

Wishaw General Hospital

Wishaw, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia France Germany Italy New Zealand Spain United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANA-PMS001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.