Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)
1 other identifier
observational
400
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2022
CompletedFirst Submitted
Initial submission to the registry
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedNovember 14, 2022
November 1, 2022
9 months
April 6, 2022
November 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
limb occlusion
freedom from limb occlusion
30 days
freedom from death
survival
30 days
Eligibility Criteria
All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company). The patients will be compared in order to detect possible significant differences in terms of perioperative risk factors that could affect the study. Risk adjustment or other statistical tools might be used to create comparable cohorts.
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Related Publications (2)
De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.
PMID: 20484396BACKGROUNDUnited Kingdom EVAR Trial Investigators; Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1863-71. doi: 10.1056/NEJMoa0909305. Epub 2010 Apr 11.
PMID: 20382983BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2022
First Posted
April 12, 2022
Study Start
February 15, 2022
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share