A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION) (INNOVATION)

A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: Cordis AAA stent graft system "INCRAFT TM"

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany
    • Universität Leipzig Herzzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AAA stent graft system; Cordis AAA stent graft system "INCRAFT TM"	Device: Cordis AAA stent graft system "INCRAFT TM"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Technical Success Through the One Month Follow up.	Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.	From procedure to one month follow up
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.	Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.	One month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Incidence of aneurysm enlargement annually through 5 years post - procedure. Aneurysm enlargement is defined as being compared to the 30 day baseline assessment.	Day 30 through year 5 post-procedure
Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Incidence of Stent-graft Migration annually through 5 years post - procedure. Stent-graft Migration is defined as being compared to the 30 day baseline assessment.	Day 30 through year 5 post-procedure
The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.	The cumulative percentage of participants with Major Adverse Events (MAE) at annually through 5 years post - procedure; i.e., the percentage of MAE at Year 1 includes all MAEs occurred during the first year, the percentage at Year 2 includes all MAEs during the first two years, and etc. The Major adverse events include death, stroke, Q wave myocardial infarction, and renal failure	From day 1 through year 5 post-procedure
The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.	The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks	From day 1 through year 5 post-procedure
The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.	The percentage of stent-graft fracture at 30 days and annually through 5 years post - procedure. Stent-graft fracture is defined as stent skeleton fracture and barb separation	From day 1 through year 5 post-procedure
The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.	The percentage of Thrombosis at hospital discharge at 30 days and annually through 5 years post - procedure.	From day 1 through year 5 post-procedure
The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.	The percentage of Stent Graft Explant at hospital discharge at 30 days and annually through 5 years post - procedure.	From day 1 through year 5 post-procedure
The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.	The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure.	From day 1 through year 5 post-procedure

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Dierk Scheinert, PhD, MD., Universität Leipzig - Herzzentrum

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 16, 2010
• First Submitted That Met QC Criteria: April 16, 2010
• First Posted (Estimate): April 19, 2010

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Endovascular repair; Performance; First in Human; AAA; Abdominal aortic aneurysm; Stent graft system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: EE09-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No