European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
- Conditions
- Abdominal Aortic Aneurysms
- Registration Number
- NCT02477111
- Lead Sponsor
- Cordis Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Major Adverse Events (MAE) Through 30 Days Within 30-days post-procedure MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
- Secondary Outcome Measures
Name Time Method Number of Participants With Major Adverse Events Through 5 Years Post-Procedure Through 5 years post-procedure MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Absence of Aneurysm Sac Rupture Within 1-year post-procedure Amount of Time Fluoroscopy is Used During the Procedure Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography Amount of Contrast Volume Used During the Procedure Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography Number of Participants With Technical Success at Conclusion of Index Procedure At the conclusion of the index procedure successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location
Absence of Type I or III Endoleak Within 1 year post-procedure defined as absence of type I or III endoleaks and absence of aneurysm enlargement (growth \>5mm compared to the 1-month size measurement) within 1-year post-procedure as assessed by the core lab
InCraft® - AAA Stent Graft System Assessed at 1 year Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure Assessed within 30-days and 1-year post-procedure Duration of INCRAFT® Procedure (Minutes) Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Trial Locations
- Locations (23)
Hospital Universitaire de Bordeaux
🇫🇷Bordeaux, France
Universitätsklinikum Münster
🇩🇪Münster, Germany
St.-Franziskus-Hospital
🇩🇪Münster, Germany
University Hospital Schleswig - Holstein
🇩🇪Kiel, Germany
University Medical Center Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Kings College Hospital
🇬🇧London, United Kingdom
Augusta Krankenhaus
🇩🇪Düsseldorf, Germany
Hopital Prive Paul d'Egine
🇫🇷Champigny-sur-Marne, France
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Complejo Universitario Hospitalario de Ourense
🇪🇸Ourense, Spain
Imperial College Healthcare NHS Trust St Mary's Hospital
🇬🇧London, United Kingdom
Hospital Clinic University of Barcelona
🇪🇸Barcelona, Spain
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Istituto Scientifico H San Raffaele
🇮🇹Milano, Italy
Ospedale S. Maria della Misericordia
🇮🇹Perugia, Italy
Azienda Ospedaleria San Camillo Forlanin
🇮🇹Rome, Italy
Skane University Hospital
🇸🇪Malmö, Sweden
Hospital de Donostia
🇪🇸Donostia-San Sebastián, Spain
Haga ziekenhuis
🇳🇱The Hague, Netherlands
Galway Clinic
🇮🇪Galway, Ireland
University Hospital Galway
🇮🇪Galway, Ireland
Radboud UMC
🇳🇱Nijmegen, Netherlands