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

November 6, 2023 updated by: Cordis Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Hospital Universitaire de Bordeaux
      • Champigny-sur-Marne, France
        • Hôpital Privé 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
        • Universitatsklinikum Wurzburg
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Within 30-days post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Technical Success at Conclusion of Index Procedure
Time Frame: At the conclusion of the 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
Time Frame: Within 1 year post-procedure
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
Time Frame: Assessed at 1 year
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
Time Frame: Assessed within 30-days and 1-year post-procedure
Assessed within 30-days and 1-year post-procedure
Absence of Aneurysm Sac Rupture
Time Frame: Within 1-year post-procedure
Within 1-year post-procedure
Duration of INCRAFT® Procedure (Minutes)
Time Frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
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
Time Frame: 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 Contrast Volume Used During the Procedure
Time Frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Number of Participants With Major Adverse Events Through 5 Years Post-Procedure
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cordis Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giovanni Torsello, MD, PhD, Universitatsklinikum Munster
  • Principal Investigator: Jean-Pierre Becquemin, MD, PhD, Chu Henri Mondor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P13-4601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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