Observational Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms (AAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Vascutek Ltd.
Sponsor:
Collaborator:
Vascutek France
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01783184
First received: January 31, 2013
Last updated: July 8, 2013
Last verified: July 2013

January 31, 2013
July 8, 2013
June 2012
October 2013   (final data collection date for primary outcome measure)
  • Overall mortality rate [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
  • Mortality rate related to rupture of the aneurysm and relationship to the stent [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
  • Change in diameter of the aneurysm [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
  • Rate of Type I, II and III endoleaks [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
  • Surgical conversion rate [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
  • Rate of endovascular or surgical revisions [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01783184 on ClinicalTrials.gov Archive Site
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Observational Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms (AAA)
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms

The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.

Infrarenal abdominal aortic aneurysms may be treated with the introduction of an abdominal aortic stent graft via the femoral route. This technique is commonly used in high surgical risk patients but can also be suitable under certain conditions for normal risk patients.

Abdominal aortic stent grafts, inserted via the femoral artery, are used to treat infrarenal abdominal aortic aneurysms, removing the need for an invasive surgical procedure.

The aim of this observational study is to evaluate the long-term (5 year) benefits of the technique by documenting the overall mortality, complications (endoleak, migration), rate of surgical conversion, progression and rupture of the aneurysm in a cohort of patients who are representative of the treated population under real conditions of use.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Abdominal Aortic Aneurysm (AAA)

Abdominal Aortic Aneurysm
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA)

Exclusion Criteria:

  • Patients for whom clinical follow-up is impossible and cannot return for check-up visits
Both
18 Years and older
No
Contact: Professor Dominique Midy (33)5 56 79 55 26 dominique.midy@chu-bordeaux.fr
France
 
NCT01783184
EPI-ANA01
No
Vascutek Ltd.
Vascutek Ltd.
Vascutek France
Principal Investigator: Professor Dominique Midy Groupe Hospitalier Pellegrin , Bordeaux, France
Vascutek Ltd.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP