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

NCT ID: NCT02477111

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-30
• Study Completion Date: 2021-12-09

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.

Conditions

Abdominal Aortic Aneurysms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Endovascular abdominal aortic aneurysm repair

Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Torsello, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Münster

Jean-Pierre Becquemin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Henri Mondor

Locations

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

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Istituto Scientifico H San Raffaele

Milan, , Italy

Ospedale S. Maria della Misericordia

Perugia, , Italy

Azienda Ospedaleria San Camillo Forlanin

Rome, , Italy

Radboud UMC

Nijmegen, , Netherlands

Haga ziekenhuis

The Hague, , Netherlands

Hospital Clinic University of Barcelona

Barcelona, , Spain

Hospital de Donostia

Donostia / San Sebastian, , Spain

Complejo Universitario Hospitalario de Ourense

Ourense, , Spain

Skane University Hospital

Malmo, , Sweden

Hull Royal Infirmary

Hull, , United Kingdom

Imperial College Healthcare NHS Trust St Mary's Hospital

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Countries

France; Germany; Ireland; Italy; Netherlands; Spain; Sweden; United Kingdom

References

Torsello G, Bertoglio L, Kellersmann R, Wever JJ, van Overhagen H, Stavroulakis K. Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study. J Endovasc Ther. 2025 Jun;32(3):766-773. doi: 10.1177/15266028231214162. Epub 2023 Nov 30.

Reference Type: DERIVED

PMID: 38031973 (View on PubMed)

Torsello G, Bertoglio L, Kellersmann R, Wever JJ, van Overhagen H, Stavroulakis K; INSIGHT study collaborators. One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms. J Vasc Surg. 2022 Jun;75(6):1904-1911.e3. doi: 10.1016/j.jvs.2021.12.066. Epub 2022 Jan 5.

Reference Type: DERIVED

PMID: 34995719 (View on PubMed)

Other Identifiers

P13-4601

Identifier Type: -

Identifier Source: org_study_id