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

NCT02477111 | Completed Results

• 1 other identifier: P13-4601
• Study Type: observational
• Target: 150
• Locations: 8 countries
• Sites: 23

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.

Conditions

Abdominal Aortic Aneurysms

Keywords

Endovascular repair

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Major Adverse Events (MAE) Through 30 Days

  MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)

  Within 30-days post-procedure

Secondary Outcomes (9)

• Number of Participants With Major Adverse Events Through 5 Years Post-Procedure

  Through 5 years post-procedure

• Number of Participants With Technical Success at Conclusion of Index Procedure

  At the conclusion of the index procedure

• Absence of Type I or III Endoleak

  Within 1 year post-procedure

• InCraft® - AAA Stent Graft System

  Assessed at 1 year

• 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

Interventions

Endovascular abdominal aortic aneurysm repair DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are eligible for endovascular repair of an abdominal aortic aneurysm

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (23)

Hospital Universitaire de Bordeaux

Bordeaux, France

Location

Hopital Prive Paul d'Egine

Champigny-sur-Marne, France

Location

Augusta Krankenhaus

Düsseldorf, Germany

Location

University Hospital Schleswig - Holstein

Kiel, Germany

Location

University Medical Center Leipzig

Leipzig, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

St.-Franziskus-Hospital

Münster, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Galway Clinic

Galway, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

Istituto Scientifico H San Raffaele

Milan, Italy

Location

Ospedale S. Maria della Misericordia

Perugia, Italy

Location

Azienda Ospedaleria San Camillo Forlanin

Rome, Italy

Location

Radboud UMC

Nijmegen, Netherlands

Location

Haga ziekenhuis

The Hague, Netherlands

Location

Hospital Clinic University of Barcelona

Barcelona, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Spain

Location

Complejo Universitario Hospitalario de Ourense

Ourense, Spain

Location

Skane University Hospital

Malmo, Sweden

Location

Hull Royal Infirmary

Hull, United Kingdom

Location

Imperial College Healthcare NHS Trust St Mary's Hospital

London, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38031973 DERIVED

• 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.

  PMID: 34995719 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

Number of participants at risk my vary depending on varying windows used for analysis, imaging availability, visits completed and will therefore not be consistent throughout report.

Results Point of Contact

• Title: Jennifer Lee, Clinical Project Manager
• Organization: Cordis, A Cardinal Health Company

jennifer.lee02@cordis.com

669-699-6851

Study Officials

• Giovanni Torsello, MD, PhD

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

• Jean-Pierre Becquemin, MD, PhD

  CHU Henri Mondor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2015
• First Posted: June 22, 2015
• Study Start: March 30, 2015
• Primary Completion: October 24, 2016
• Study Completion: December 9, 2021
• Last Updated: April 9, 2024
• Results First Posted: April 22, 2021

Record last verified: 2023-11

Locations

SE (1); GB (3); ES (3); IT (4); NL (2); FR (2); DE (6); IE (2)