Brief Title
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)
Official Title
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
Brief Summary
This study is a multi-center prospective, open label, non-randomized investigation of
INCRAFT™ in subjects with abdominal aortic aneurysms.
The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
Detailed Description
This study is a multi-center prospective, open label, non-randomized investigation of
INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects
at 7 sites in Germany and Italy. All treated subjects will be evaluated at 1 month, 3 months
(if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. An
interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow
up visit
Study Type
Interventional
Primary Outcome
Rate of Technical Success Through the One Month Follow up.
Secondary Outcome
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.
Condition
Abdominal Aortic Aneurysms
Intervention
Cordis AAA stent graft system "INCRAFT TM"
Study Arms / Comparison Groups
AAA stent graft system
Description: Cordis AAA stent graft system "INCRAFT TM"
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
60
Start Date
March 2010
Completion Date
October 2016
Primary Completion Date
August 2011
Eligibility Criteria
INCLUSION CRITERIA:
1. Subject is a male or infertile female > 18 years of age
2. Subject understands study requirements and treatment procedures and agrees to sign an
informed consent form prior to any study procedures.
3. Subject is considered an appropriate candidate for open surgical repair of an
abdominal aortic aneurysm.
4. Subject has at least one of the following:
1. Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter
2. Aneurysm, which is >4 cm and which has increased in size by 0.5 cm within 6
months
3. The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter
4. Saccular aneurysm
5. Subject has access vessel size compatible with vascular access techniques and
potential accessories used with delivery profile of 14Fr
6. Subject aortic aneurysm neck is ≥15 mm in length
7. Subject iliac landing zone≥10mm in length
8. Subject has distal iliac landing sites with diameter ranges of 9-18mm
9. Subject proximal aortic attachment is between 20-27 mm in diameter.
10. Subject has a minimum overall AAA treatment length (from lowest renal artery to distal
landing zone) of 140 mm.
11. Subject is willing to comply with all specified follow-up evaluations.
EXCLUSION CRITERIA:
1. Subject has one of the following:
1. a dissecting or inflammatory aneurysm
2. acutely ruptured aneurysm
3. pararenal or leaking aneurysm
2. The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal
diameter of the aortic bifurcate prosthesis
3. Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm
4. Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing
zones
5. Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta
6. Subject has aneurysm neck angulations that are >60° in the supra-renal and/or
infra-renal locations
7. Aortic bifurcation ≤18mm in diameter
8. Acute vascular injury due to trauma
9. Subject has a known allergy to contrast medium
10. Subject has known allergy to nitinol, PET or PTFE
11. Subject has a need for emergent surgery
12. Subject has a contraindication to undergoing angiography
13. Subject has a thoracic aortic aneurysm that requires treatment
14. Subject has Infra-renal aortic dissection
15. Subject has an Iliac anatomy which would require occlusion of both internal iliac
arteries
16. Subject has congenital abnormalities in which the placement of the stent-graft will
cause occlusion of major arterial flow. Such abnormalities should be evaluated (e.g.
angiography or CT) prior to treatment
17. Subject has unstable angina as defined by Braunwald angina classification
18. Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely
inhibit visualization of the aorta
19. Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome)
20. Subject has known bleeding or hypercoagulable disorder
21. Subject has contraindication for anticoagulation
22. Subject with Stroke or MI or intracranial bleeding within 3 months prior to the
procedure
23. Subject with renal insufficiency (creatinine > 2.0 mg/dl)
24. Subject has known or suspected active infection at the time of the index procedure
(for ex. Pneumonia, acute virus infection, contaminated wounds etc)
25. Subject is currently taking systemic immunosuppressant therapy
26. Subject had a major surgical procedure within 30 days prior to procedure or planned
within 30 days post procedure
27. Subject has a life expectancy less than 2 years
28. Subject is currently participating in another research study involving an
investigational device or new drug
29. Other medical, social, or psychological issues that in the opinion of the investigator
preclude them from receiving this treatment, and the procedures and evaluations pre-
and post-treatment
30. Subject with an existing AAA surgical graft and/or a AAA stent-graft system
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Dierk Scheinert, PhD, MD., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01106391
Organization ID
EE09-01
Responsible Party
Sponsor
Study Sponsor
Cordis Corporation
Study Sponsor
Dierk Scheinert, PhD, MD., Principal Investigator, Universität Leipzig - Herzzentrum
Verification Date
April 2022