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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: Endovascular abdominal aortic aneurysm repair

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Hospital Universitaire de Bordeaux
  • Champigny-sur-Marne, France
    • Hopital Prive Paul d'Egine
• Germany
  • Düsseldorf, Germany
    • Augusta Krankenhaus
  • Kiel, Germany
    • University Hospital Schleswig - Holstein
  • Leipzig, Germany
    • University Medical Center Leipzig
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Münster, Germany
    • St.-Franziskus-Hospital
  • Würzburg, Germany
    • Universitätsklinikum Würzburg
• Ireland
  • Galway, Ireland
    • University Hospital Galway
  • Galway, Ireland
    • Galway Clinic
• Italy
  • Firenze, Italy
    • Azienda Ospedaliera Universitaria Careggi
  • Milano, Italy
    • Istituto Scientifico H San Raffaele
  • Perugia, Italy
    • Ospedale S. Maria Della Misericordia
  • Rome, Italy
    • Azienda Ospedaleria San Camillo Forlanin
• Netherlands
  • Nijmegen, Netherlands
    • Radboud UMC
  • The Hague, Netherlands
    • Haga ziekenhuis
• Spain
  • Barcelona, Spain
    • Hospital Clinic University of Barcelona
  • Donostia-San Sebastián, Spain
    • Hospital de Donostia
  • Ourense, Spain
    • Complejo Universitario Hospitalario de Ourense
• Sweden
  • Malmö, Sweden
    • Skåne University Hospital
• United Kingdom
  • Hull, United Kingdom
    • Hull Royal Infirmary
  • London, United Kingdom
    • Kings College Hospital
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Technical Success at Conclusion of Index Procedure	successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location	At the conclusion of the index procedure
Absence of Type I or III Endoleak	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	Within 1 year post-procedure
InCraft® - AAA Stent Graft System	Single Arm EVAR Subjects who underwent procedure for the implant of 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
Absence of Aneurysm Sac Rupture		Within 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
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 Major Adverse Events Through 5 Years Post-Procedure	MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)	Through 5 years post-procedure

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Giovanni Torsello, MD, PhD, Universitatsklinikum Munster; Principal Investigator: Jean-Pierre Becquemin, MD, PhD, CHU Henri Mondor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2015
• Primary Completion (Actual): October 24, 2016
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: May 30, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimated): June 22, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Endovascular repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: P13-4601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED