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

A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms

NCT02477111•Cordis US Corp.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+2 more criteria

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

Locations (23)

Hospital Universitaire de Bordeaux

Bordeaux, France

Hopital Prive Paul d'Egine

Champigny-sur-Marne, France

Augusta Krankenhaus

Düsseldorf, Germany

University Hospital Schleswig - Holstein

Kiel, Germany

University Medical Center Leipzig

Leipzig, Germany

Universitätsklinikum Münster

Münster, Germany

St.-Franziskus-Hospital

Münster, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Galway Clinic

Galway, Ireland

University Hospital Galway

Galway, Ireland

Key Dates

Start Date

March 30, 2015

Primary Completion Date

October 24, 2016

Completion Date

December 9, 2021

Last Updated

April 9, 2024

Enrollment

150

ACTUAL participants

Conditions

Abdominal Aortic Aneurysms

Interventions

Endovascular abdominal aortic aneurysm repair

DEVICE

Investigating Practice Patterns in Symptomatic Non-ruptured Abdominal Aortic Aneurysms (AAA) in Europe

NCT07184723

Symptomatic Non-ruptured Abdominal Aortic Aneurysms

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RECRUITINGNA

Thoracoabdominal Artery Stent Graft System Exploratory Study

NCT06710938

Thoracoabdominal Aortic Aneurysms

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RECRUITING

Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

NCT06884397

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Investigating Practice Patterns in Symptomatic Non-ruptured Abdominal Aortic Aneurysms (AAA) in Europe

Thoracoabdominal Artery Stent Graft System Exploratory Study

Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Validation of Fenestrations Positioning by Numerical Simulation

AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft