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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02477111
Recruitment Status : Active, not recruiting
First Posted : June 22, 2015
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation

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 postprocedure. Up to 25 sites in Europe may participate.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Endovascular 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.


Primary Outcome Measures :
  1. Absence of major adverse events [ Time Frame: Within 30-days post-procedure ]

Secondary Outcome Measures :
  1. Occurence of major adverse events [ Time Frame: Through 5 years post-procedure ]
  2. Technical success defined as successful insertion and deployment of the device in the intended location . [ Time Frame: At the conclusion of the index procedure ]
  3. Successful aneurysm repair defined as absence of Type I or III endoleak and absence of aneurysm enlargement confirmed on imaging. [ Time Frame: Within 1 year post-procedure ]
  4. Absence of stent graft migration (> 10 mm) [ Time Frame: Assessed at 1 year ]
  5. Absence of stent graft fracture [ 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. Amount of time it takes to complete the procedure [ Time Frame: participants will be followed for the duration of their hospital stay, an average of 2 days ]
  8. Amount of time fluoroscopy is used during the procedure [ Time Frame: participants will be followed for the duration of their hospital stay, an average of 2 days ]
  9. Amount of contrast volume used during the procedure [ Time Frame: participants will be followed for the duration of their hospital stay, an average of 2 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477111


Locations
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Germany
Universitätsklinikum Münster
Münster, Germany, 48149
Sponsors and Collaborators
Cordis Corporation
Investigators
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Principal Investigator: Giovanni Torsello, MD, PhD Universitätsklinikum Münster
Principal Investigator: Jean-Pierre Becquemin, MD, PhD CHU Henri Mondor

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Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT02477111     History of Changes
Other Study ID Numbers: P13-4601
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Cordis Corporation:
Endovascular repair

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases