Clinical trial NCT02477111: European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysms
Keywords: Endovascular repair
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are eligible for endovascular repair of an abdominal aortic aneurysm

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Major Adverse Events (MAE) Through 30 Days
timeFrame: Within 30-days post-procedure
Secondary outcomes:
measure: Number of Participants With Major Adverse Events Through 5 Years Post-Procedure
timeFrame: Through 5 years post-procedure
measure: Number of Participants With Technical Success at Conclusion of Index Procedure
timeFrame: At the conclusion of the index procedure
measure: Absence of Type I or III Endoleak
timeFrame: Within 1 year post-procedure
measure: InCraft® - AAA Stent Graft System
timeFrame: Assessed at 1 year
measure: Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
timeFrame: Assessed within 30-days and 1-year post-procedure
measure: Absence of Aneurysm Sac Rupture
timeFrame: Within 1-year post-procedure
measure: Duration of INCRAFT® Procedure (Minutes)
timeFrame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
measure: Amount of Time Fluoroscopy is Used During the Procedure
timeFrame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
measure: Amount of Contrast Volume Used During the Procedure
timeFrame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hospital Universitaire de Bordeaux
city: Champigny-sur-Marne
country: France
facility: Hopital Prive Paul d'Egine
city: Düsseldorf
country: Germany
facility: Augusta Krankenhaus
city: Kiel
country: Germany
facility: University Hospital Schleswig - Holstein
city: Leipzig
country: Germany
facility: University Medical Center Leipzig
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Münster
country: Germany
facility: St.-Franziskus-Hospital
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Galway
country: Ireland
facility: Galway Clinic
city: Galway
country: Ireland
facility: University Hospital Galway
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: Istituto Scientifico H San Raffaele
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia
city: Rome
country: Italy
facility: Azienda Ospedaleria San Camillo Forlanin
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: The Hague
country: Netherlands
facility: Haga ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Clinic University of Barcelona
city: Donostia-San Sebastián
country: Spain
facility: Hospital de Donostia
city: Ourense
country: Spain
facility: Complejo Universitario Hospitalario de Ourense
city: Malmö
country: Sweden
facility: Skane University Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust St Mary's Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Universitätsklinikum Münster
name: Giovanni Torsello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Henri Mondor
name: Jean-Pierre Becquemin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.