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Clinical Trials/NCT05324657
NCT05324657
Completed
Not Applicable

Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)

IRCCS San Raffaele1 site in 1 country400 target enrollmentFebruary 15, 2022

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

Registry
clinicaltrials.gov
Start Date
February 15, 2022
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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