NCT05324657
Completed
Not Applicable
Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)
ConditionsAneurysm Abdominal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneurysm Abdominal
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- limb occlusion
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim was to determine, within the patient enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company) studies which are preoperative and postoperative anatomical risk factors associated to limb occlusion. In the three studies the total number of enrolled patients was 400, of whom 134 enrolled in the US
Investigators
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele
Eligibility Criteria
Inclusion Criteria
- •Patients with abdominal aortic aneurysm, who have been treated with the INCRAFT® Grafting System (AAA Stent-Graft System).
- •All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company)
Exclusion Criteria
- •no exclusion criteria
Outcomes
Primary Outcomes
limb occlusion
Time Frame: 30 days
freedom from limb occlusion
freedom from death
Time Frame: 30 days
survival
Study Sites (1)
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