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

Completed

• Conditions: Aneurysm Abdominal

• Registration Number: NCT05324657
• Lead Sponsor: IRCCS San Raffaele

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-12
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
limb occlusion	30 days	freedom from limb occlusion
freedom from death	30 days	survival

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy