Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysm
Sponsor Vascutek Ltd.
Collaborator Vascutek France
Start date June 2012
End date October 2013
Trial size 180 participants
Trial identifier NCT01783184, EPI-ANA01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Overall mortality rate
time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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
Change in diameter of the aneurysm
time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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
Surgical conversion rate
time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of endovascular or surgical revisions
time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
Principal investigator Professor Dominique Midy
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Vascutek Ltd..