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

Abdominal Aortic Aneurysms Clinical Trial

— INSIGHT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477111
• Other study ID #: P13-4601
• Status: Completed
• Start date: March 30, 2015
• Est. completion date: December 9, 2021

Study information

• Verified date: November 2023
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 9, 2021
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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.

Locations

Country	Name	City	State
France	Hospital Universitaire de Bordeaux	Bordeaux
France	Hopital Prive Paul d'Egine	Champigny-sur-Marne
Germany	Augusta Krankenhaus	Düsseldorf
Germany	University Hospital Schleswig - Holstein	Kiel
Germany	University Medical Center Leipzig	Leipzig
Germany	St.-Franziskus-Hospital	Münster
Germany	Universitätsklinikum Münster	Münster
Germany	Universitätsklinikum Würzburg	Würzburg
Ireland	Galway Clinic	Galway
Ireland	University Hospital Galway	Galway
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Istituto Scientifico H San Raffaele	Milano
Italy	Ospedale S. Maria della Misericordia	Perugia
Italy	Azienda Ospedaleria San Camillo Forlanin	Rome
Netherlands	Radboud UMC	Nijmegen
Netherlands	Haga ziekenhuis	The Hague
Spain	Hospital Clinic University of Barcelona	Barcelona
Spain	Hospital de Donostia	Donostia-San Sebastián
Spain	Complejo Universitario Hospitalario de Ourense	Ourense
Sweden	Skane University Hospital	Malmö
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Imperial College Healthcare NHS Trust St Mary's Hospital	London
United Kingdom	Kings College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Countries where clinical trial is conducted

France,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Within 30-days post-procedure
Secondary	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)	Through 5 years post-procedure
Secondary	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	At the conclusion of the index procedure
Secondary	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	Within 1 year post-procedure
Secondary	InCraft® - AAA Stent Graft System	Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System	Assessed at 1 year
Secondary	Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure		Assessed within 30-days and 1-year post-procedure
Secondary	Absence of Aneurysm Sac Rupture		Within 1-year post-procedure
Secondary	Duration of INCRAFT® Procedure (Minutes)	Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography	Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Secondary	Amount of Time Fluoroscopy is Used During the Procedure		Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Secondary	Amount of Contrast Volume Used During the Procedure		Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography