Clinical trial NCT01106391: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysms
Keywords: Abdominal aortic aneurysm
AAA
Safety
Performance
Stent graft system
First in Human
Endovascular repair
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Rate of Technical Success Through the One Month Follow up.
timeFrame: From procedure to one month follow up
measure: Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
timeFrame: One month follow-up
Secondary outcomes:
measure: Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.
timeFrame: Day 30 through year 5 post-procedure
measure: Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.
timeFrame: Day 30 through year 5 post-procedure
measure: The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.
timeFrame: From day 1 through year 5 post-procedure
measure: The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.
timeFrame: From day 1 through year 5 post-procedure
measure: The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.
timeFrame: From day 1 through year 5 post-procedure
measure: The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.
timeFrame: From day 1 through year 5 post-procedure
measure: The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.
timeFrame: From day 1 through year 5 post-procedure
measure: The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.
timeFrame: From day 1 through year 5 post-procedure
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitat Leipzig Herzzentrum
Study officials:
affiliation: Universität Leipzig - Herzzentrum
name: Dierk Scheinert, PhD, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheinert D, Pratesi C, Chiesa R, Coppi G, Brunkwall JS, Klarenbeek G, Cebrian A, Torsello G. First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial. J Vasc Surg. 2013 Apr;57(4):906-14. doi: 10.1016/j.jvs.2012.09.079. Epub 2013 Jan 18.
citation: Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT ultra-low profile AAA stent-graft system. J Cardiovasc Surg (Torino). 2011 Oct;52(5):661-7.
citation: Coppi G, Njila M, Coppi G, Saitta G, Silingardi R, Pratesi C, Chiesa R, Scheinert D, Brunkwall JS, Torsello G. INCRAFT(R) Stent-Graft System: one-year outcome of the INNOVATION Trial. J Cardiovasc Surg (Torino). 2014 Feb;55(1):51-9.
citation: Torsello G, Scheinert D, Brunkwall JS, Chiesa R, Coppi G, Pratesi C. Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2015 Jan;61(1):1-8. doi: 10.1016/j.jvs.2014.06.007. Epub 2014 Jul 19.
citation: Torsello G, Pratesi G, van der Meulen S, Ouriel K; INNOVATION trial collaborators. Aortoiliac remodeling and 5-year outcome of an ultralow-profile endograft. J Vasc Surg. 2019 Jun;69(6):1747-1757. doi: 10.1016/j.jvs.2018.09.059. Epub 2018 Dec 24.