Abdominal Aortic AneurysmsINSIGHTNCT02477111
European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysms, run by Cordis US Corp. at 23 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Endovascular abdominal aortic aneurysm repair
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 30 Mar 2015to 9 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
Who may be able to join
- 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°
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Germany6 sites
Augusta Krankenhaus
Düsseldorf
University Hospital Schleswig - Holstein
Kiel
University Medical Center Leipzig
Leipzig
Universitätsklinikum Münster
Münster, 48149
St.-Franziskus-Hospital
Münster
Universitätsklinikum Würzburg
Würzburg
Italy4 sites
Azienda Ospedaliera Universitaria Careggi
Florence
Istituto Scientifico H San Raffaele
Milan
Ospedale S. Maria della Misericordia
Perugia
Azienda Ospedaleria San Camillo Forlanin
Rome
Spain3 sites
Hospital Clinic University of Barcelona
Barcelona
Hospital de Donostia
Donostia / San Sebastian
Complejo Universitario Hospitalario de Ourense
Ourense
United Kingdom3 sites
Hull Royal Infirmary
Hull
Imperial College Healthcare NHS Trust St Mary's Hospital
London
Kings College Hospital
London
France2 sites
Hospital Universitaire de Bordeaux
Bordeaux
Hopital Prive Paul d'Egine
Champigny-sur-Marne
About this study
Official title: 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.
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.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Endovascular abdominal aortic aneurysm repair
- Keywords
- Endovascular repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular abdominal aortic aneurysm repairDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 30-days post-procedure
Secondary outcomes (9)
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)
Measured: Through 5 years post-procedure
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
Measured: 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
Measured: 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
Measured: Assessed at 1 year
Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
Measured: Assessed within 30-days and 1-year post-procedure
Absence of Aneurysm Sac Rupture
Measured: Within 1-year post-procedure
Duration of INCRAFT® Procedure (Minutes)
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Measured: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Amount of Time Fluoroscopy is Used During the Procedure
Measured: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Amount of Contrast Volume Used During the Procedure
Measured: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study start30 Mar 2015
- Primary completion24 Oct 2016
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Torsello, MD, PhD, Principal investigator, Universitätsklinikum MünsterJean-Pierre Becquemin, MD, PhD, Principal investigator, CHU Henri Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477111
- Sponsor's protocol ID
- P13-4601
- Acronym
- INSIGHT
- Status last verified
- Nov 2023
- First submitted
- 30 May 2015
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 38031973Torsello 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02477111
- Acronym / sponsor ID
- INSIGHT / P13-4601
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Endovascular repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Posted 22 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- Subject has one of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular abdominal aortic aneurysm repairSubjects 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. | Device | – |
Primary outcome
Number of Participants With Major Adverse Events (MAE) Through 30 Days
Time frame: Within 30-days post-procedure
MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
9 secondary outcomes
Number of Participants With Major Adverse Events Through 5 Years Post-Procedure
Time frame: Through 5 years post-procedure
Number of Participants With Technical Success at Conclusion of Index Procedure
Time frame: At the conclusion of the index procedure
Absence of Type I or III Endoleak
Time frame: Within 1 year post-procedure
InCraft® - AAA Stent Graft System
Time frame: Assessed at 1 year
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
Absence of Aneurysm Sac Rupture
Time frame: Within 1-year post-procedure
Duration of INCRAFT® Procedure (Minutes)
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Amount of Time Fluoroscopy is Used During the Procedure
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Amount of Contrast Volume Used During the Procedure
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38031973Torsello 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.
- Derived from this study: PubMed 34995719Torsello 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Torsello, MD, PhD principal investigator
Universitätsklinikum Münster
Jean-Pierre Becquemin, MD, PhD principal investigator
CHU Henri Mondor
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms, run by Cordis US Corp. at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Italy, Spain, United Kingdom, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Major Adverse Events (MAE) Through 30 Days (time frame: Within 30-days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02477111, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.