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CompletedNCT02477111INSIGHTUpdated Apr 9, 2024Results posted

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

An observational study in Abdominal Aortic Aneurysms, sponsored by Cordis US Corp.. Completed at 23 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Cordis US Corp. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Abdominal Aortic Aneurysms

Keywords

  • Endovascular repair
03

In context

Aortic Aneurysm, Abdominal

481 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's enrollment of 150 is below the median of 167 across 225 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Cordis US Corp. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Browse Cordis Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Interventions

  • DeviceEndovascular 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.

06

What researchers measure

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)

    Time frame: Within 30-days post-procedure

Secondary outcomes

  1. 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)

    Time frame: Through 5 years post-procedure

  2. 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

    Time frame: At the conclusion of the index procedure

  3. 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

    Time frame: Within 1 year post-procedure

  4. InCraft® - AAA Stent Graft System

    Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System

    Time frame: Assessed at 1 year

  5. Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure

    Time frame: Assessed within 30-days and 1-year post-procedure

  6. Absence of Aneurysm Sac Rupture

    Time frame: Within 1-year post-procedure

  7. Duration of INCRAFT® Procedure (Minutes)

    Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

    Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

  8. Amount of Time Fluoroscopy is Used During the Procedure

    Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

  9. Amount of Contrast Volume Used During the Procedure

    Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

07

Results

Posted Apr 22, 2021
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.

Participant flow

Participants were recruited based on physician referral at 25 academic medical centers between 2015 and the last participant was enrolled September 15, 2016

Participant flow — Overall Study
MilestoneInCraft® - AAA Stent Graft System
Started150
Completed99
Not completed51
Withdrew: Death28
Withdrew: Withdrawal by subject19
Withdrew: Lost to follow-up4

Outcome measures

PrimaryNumber 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)

Time frame:
Within 30-days post-procedure
Reported as:
Number · participants
Number of Participants With Major Adverse Events (MAE) Through 30 Days
participantsInCraft® - AAA Stent Graft System
Number of Participants With Major Adverse Events (MAE) Through 30 Days0 (0.0 to 2.4)
SecondaryNumber 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)

Time frame:
Through 5 years post-procedure
Reported as:
Number · participants
Number of Participants With Major Adverse Events Through 5 Years Post-Procedure
participantsInCraft® - AAA Stent Graft System
Number of Participants With Major Adverse Events Through 5 Years Post-Procedure44 (33.604 to 55.304)
SecondaryNumber 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

Time frame:
At the conclusion of the index procedure
Reported as:
Count of participants · Participants
Number of Participants With Technical Success at Conclusion of Index Procedure
ParticipantsInCraft® - AAA Stent Graft System
Number of Participants With Technical Success at Conclusion of Index Procedure149
SecondaryAbsence 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

Time frame:
Within 1 year post-procedure
Reported as:
Number · participants
Absence of Type I or III Endoleak
participantsInCraft® - AAA Stent Graft System
Absence of Type I or III Endoleak108 (101.085 to 112.125)
SecondaryInCraft® - AAA Stent Graft System

Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System

Time frame:
Assessed at 1 year
Reported as:
Number · participants
InCraft® - AAA Stent Graft System
participantsAbsence of Stent-graft Migration (>10 mm) Assessed at 1-year
InCraft® - AAA Stent Graft System122 (118.4 to 122)
SecondaryNumber of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
Time frame:
Assessed within 30-days and 1-year post-procedure
Reported as:
Count of participants · Participants
Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
ParticipantsInCraft® - AAA Stent Graft System
Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure141
SecondaryAbsence of Aneurysm Sac Rupture
Time frame:
Within 1-year post-procedure
Reported as:
Count of participants · Participants
Absence of Aneurysm Sac Rupture
ParticipantsAbsence of Stent-graft Migration (>10 mm) Assessed at 1-year
Absence of Aneurysm Sac Rupture138
SecondaryDuration of INCRAFT® Procedure (Minutes)

Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography

Time frame:
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Reported as:
Mean · minutes
Duration of INCRAFT® Procedure (Minutes)
minutesInCraft® - AAA Stent Graft System
Duration of INCRAFT® Procedure (Minutes)42.3 (39.4 to 45.2)
SecondaryAmount of Time Fluoroscopy is Used During the Procedure
Time frame:
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Reported as:
Mean · minutes
Amount of Time Fluoroscopy is Used During the Procedure
minutesInCraft® - AAA Stent Graft System
Amount of Time Fluoroscopy is Used During the Procedure17.3 (15.9 to 18.8)
SecondaryAmount of Contrast Volume Used During the Procedure
Time frame:
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Reported as:
Mean · ml
Amount of Contrast Volume Used During the Procedure
mlInCraft® - AAA Stent Graft System
Amount of Contrast Volume Used During the Procedure99.4 (92.0 to 106.7)

Adverse events

Collected over Adverse events are collected from index procedure until completion of study or early termination. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
INSIGHT28/124 (22.6%)21/104 (20.2%)22/104 (21.2%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventINSIGHT
Cardiac disordersCardiac disorders5/104
Infections and infestationsInfections and infestations5/104
Gastrointestinal disordersGastrointestinal disorders3/104
Nervous system disordersNervous system disorders3/104
Vascular disordersVascular disorders2/104
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications1/104
Neoplasms benign, malignant and unspecified (including cysts and polyps)Neoplasms benign, malignant and unspecified (incl cysts and polyps)1/104
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders1/104
Hepatobiliary disordersHepatobiliary disorders1/104
General disorders and administration site conditionsGeneral disorders0/104
Most frequent other events
Showing 10 of 22
Most frequent other events
EventINSIGHT
Vascular disordersVascular disorders7/104
General disorders and administration site conditionsGeneral disorders5/104
Gastrointestinal disordersGastrointestinal disorders4/104
Infections and infestationsInfections and infestations3/104
Blood and lymphatic system disordersBlood and lymphatic system disorders1/104
Cardiac arrhythmiasCardiac disorders1/104
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders1/104
Renal and urinary disordersRenal and urinary disorders1/104
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders1/104
Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders1/104

Baseline characteristics

Age, Continuous
Age, Continuous(years)InCraft® - AAA Stent Graft System
Mean73.6 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)InCraft® - AAA Stent Graft System
Female16
Male134
Angina
Angina(Participants)InCraft® - AAA Stent Graft System
Count of participants14
Arrhythmia
Arrhythmia(Participants)InCraft® - AAA Stent Graft System
Count of participants36
Coronary artery disease
Coronary artery disease(Participants)InCraft® - AAA Stent Graft System
Count of participants44
Myocardial infarction
Myocardial infarction(Participants)InCraft® - AAA Stent Graft System
Count of participants27
Percutaneous transluminal coronary angioplasty and/or stent
Percutaneous transluminal coronary angioplasty and/or stent(Participants)InCraft® - AAA Stent Graft System
Count of participants28
Coronary artery bypass grafting
Coronary artery bypass grafting(Participants)InCraft® - AAA Stent Graft System
Count of participants19

18 further baseline measures are reported on the registry.

08

Study locations

23 sites
  • 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, 48149, 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
    Malmö, 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
09

References and documents

Publications

  • 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. PubMed 38031973 ↗
  • 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. PubMed 34995719 ↗

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02477111
Lead sponsor
Cordis US Corp.
Responsible party
Sponsor
First posted
Jun 22, 2015
Start date
Mar 30, 2015
Primary completion
Oct 24, 2016
Completion
Dec 9, 2021
Results posted
Apr 22, 2021
Last update
Apr 9, 2024

Study contacts

Giovanni Torsello, MD, PhD
principal investigator · Universitätsklinikum Münster
Jean-Pierre Becquemin, MD, PhD
principal investigator · CHU Henri Mondor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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