Brief Title
European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
Official Title
A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms
Brief Summary
INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.
Detailed Description
INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate. Subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years.
Study Type
Observational
Primary Outcome
Number of Participants With Major Adverse Events (MAE) Through 30 Days
Secondary Outcome
Occurence of Major Adverse Events
Condition
Abdominal Aortic Aneurysms
Intervention
Endovascular abdominal aortic aneurysm repair
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
150
Start Date
March 2015
Completion Date
December 2022
Primary Completion Date
October 2016
Eligibility Criteria
Inclusion Criteria: 1. Male or Female age 18 years or older 2. Femoral access vessels should be adequate to fit the selected delivery system 3. Proximal neck length ≥ 10mm 4. Aortic neck diameters ≥ 17mm and ≤ 31mm 5. Aortic neck suitable for suprarenal fixation 6. Infrarenal and suprarenal neck angulation ≤ 60° 7. Iliac fixation length ≥ 15mm 8. Iliac diameters ≥ 7mm and ≤ 22mm 9. Minimum overall AAA treatment length (proximal landing location to distal landing location) ≥ 128mm 10. Morphology suitable for aneurysm repair 11. Provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures 12. Subject is willing to comply with the specified follow-up evaluation schedule Exclusion Criteria: 1. Subject has one of the following: 1. Aneurysm sac rupture or leaking abdominal aortic aneurysm 2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm 2. Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE) 3. Known contraindication to undergoing angiography or anticoagulation 4. Existing AAA surgical graft and/or a AAA stent-graft system 5. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Giovanni Torsello, MD, PhD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02477111
Organization ID
P13-4601
Responsible Party
Sponsor
Study Sponsor
Cordis Corporation
Study Sponsor
Giovanni Torsello, MD, PhD, Principal Investigator, Universitätsklinikum Münster
Verification Date
April 2021