NCT01744119

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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
7 countries

21 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

11.1 years

First QC Date

November 29, 2012

Last Update Submit

May 23, 2016

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (3)

  • 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.

    60 months

  • Graft patency

    Data will be collected and analysed on endoleak exclusion and graft migration rates

    60 months

  • Exclusion of aneurysm

    60 months

Study Arms (1)

Abdominal Aortic Aneurysm

Device: Vascutek Anaconda™ Stent Graft System

Interventions

Vascutek Anaconda™ Stent Graft SystemDEVICE
Abdominal Aortic Aneurysm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with a CE-Marked Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

You may qualify if:

  • Patient is implanted with Anaconda™ Stent Graft System

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Dalcross Private Hospital

Killara, New South Wales, 2071, Australia

Location

Newcastle Private Medical Suites

Newcastle, New South Wales, NSW 2305, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

The Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Geelong Regional Vascular Service

Geelong, 3220, Australia

Location

Royal Perth Hospital

Perth, 6000, Australia

Location

Hollywood, Royal Perth

Perth, WA 6000, Australia

Location

Clinique Guillaume De Varye

Saint-Doulchard, 18230, France

Location

DRK Kliniken Mark Brandenburg

Berlin, 13359, Germany

Location

Dresden-Friedrichstadt

Dresden, 0167, Germany

Location

Klinikum Grosshadern

Munich, 81377, Germany

Location

San Orsola - Bologna University

Bologna, Italy

Location

University federico II

Naples, 80138, Italy

Location

Guglielmo da Saliceto

Piacenza, Italy

Location

Casa di Cura Nuova Itor

Roma, 00158, Italy

Location

Christchurch Hospital, CDHB

Christchurch, 8011, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Hospital Universitario Madrid Monteprincipe

Madrid, 28660, Spain

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Wishaw General Hospital

Wishaw, ML2 0DP, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 6, 2012

Study Start

April 1, 2005

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations

GB(3)IT(4)DE(3)AU(7)ES(1)FR(1)NZ(2)