N/A
Completed N=150
European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysms
Source: ClinicalTrials.gov NCT02477111 ↗
Enrolled (actual)
150
Serious AEs
20.2%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With Major Adverse Events (MAE) Through 30 Days — 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Events (MAE) Through 30 Days |
— | — |
| SECONDARY Number of Participants With Major Adverse Events Through 5 Years Post-Procedure |
44 | — |
| SECONDARY Number of Participants With Technical Success at Conclusion of Index Procedure |
149 | — |
| SECONDARY Absence of Type I or III Endoleak |
108 | — |
| SECONDARY InCraft® - AAA Stent Graft System |
122 | — |
| SECONDARY Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure |
141 | — |
| SECONDARY Absence of Aneurysm Sac Rupture |
138 | — |
| SECONDARY Duration of INCRAFT® Procedure (Minutes) |
42.3 | — |
| SECONDARY Amount of Time Fluoroscopy is Used During the Procedure |
17.3 | — |
| SECONDARY Amount of Contrast Volume Used During the Procedure |
99.4 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female age 18 years or older
- Femoral access vessels should be adequate to fit the selected delivery system
- Proximal neck length ≥ 10mm
- Aortic neck diameters ≥ 17mm and ≤ 31mm
- Aortic neck suitable for suprarenal fixation
- Infrarenal and suprarenal neck angulation ≤ 60°
- Iliac fixation length ≥ 15mm
- Iliac diameters ≥ 7mm and ≤ 22mm
- Minimum overall AAA treatment length (proximal landing location to distal landing location) ≥ 128mm
- Morphology suitable for aneurysm repair
- Provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures
- Subject is willing to comply with the specified follow-up evaluation schedule
Exclusion Criteria
- Subject has one of the following:
- Aneurysm sac rupture or leaking abdominal aortic aneurysm
- Mycotic, dissecting, or inflammatory abdominal aortic aneurysm
- Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE)
- Known contraindication to undergoing angiography or anticoagulation
- Existing AAA surgical graft and/or a AAA stent-graft system
- Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
Data sourced from ClinicalTrials.gov (NCT02477111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.