European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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