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

Cordis

Status: Completed

Conditions: Abdominal Aortic Aneurysms

Treatments: Device: Endovascular abdominal aortic aneurysm repair

Study type: Observational

Funder types: Industry

Identifiers

NCT02477111

P13-4601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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