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

NCT01106391 | Completed Results DMC

• 1 other identifier: EE09-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysms

Keywords

Abdominal aortic aneurysm; AAA; Safety; Performance; Stent graft system; First in Human; Endovascular repair

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.

  Day 30 through year 5 post-procedure

• Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.

  Day 30 through year 5 post-procedure

• The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.

  From day 1 through year 5 post-procedure

• The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.

  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.

  From day 1 through year 5 post-procedure

Study Arms (1)

AAA stent graft system

EXPERIMENTAL

Cordis AAA stent graft system "INCRAFT TM"

Device: Cordis AAA stent graft system "INCRAFT TM"

Interventions

Cordis AAA stent graft system "INCRAFT TM" DEVICE

AAA stent graft system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male or infertile female \> 18 years of age
• Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures.
• Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
• Subject has at least one of the following:
• Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter
• Aneurysm, which is \>4 cm and which has increased in size by 0.5 cm within 6 months
• The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter
• Saccular aneurysm
• Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr
• Subject aortic aneurysm neck is ≥15 mm in length
• Subject iliac landing zone≥10mm in length
• Subject has distal iliac landing sites with diameter ranges of 9-18mm
• Subject proximal aortic attachment is between 20-27 mm in diameter.
• Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm.
• Subject is willing to comply with all specified follow-up evaluations.

You may not qualify if:

• Subject has one of the following:
• a dissecting or inflammatory aneurysm
• acutely ruptured aneurysm
• pararenal or leaking aneurysm
• The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis
• Aortic length (lowest renal artery origin to the aortic bifurcation) of \<8.7 cm
• Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones
• Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta
• Subject has aneurysm neck angulations that are \>60° in the supra-renal and/or infra-renal locations
• Aortic bifurcation ≤18mm in diameter
• Acute vascular injury due to trauma
• Subject has a known allergy to contrast medium
• Subject has known allergy to nitinol, PET or PTFE
• Subject has a need for emergent surgery
• Subject has a contraindication to undergoing angiography

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Universitat Leipzig Herzzentrum

Leipzig, Germany

Location

Related Publications (5)

• 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.

  PMID: 23332982 BACKGROUND

• 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.

  PMID: 21894137 BACKGROUND

• 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.

  PMID: 24356046 BACKGROUND

• 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.

  PMID: 25053535 BACKGROUND

• 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.

  PMID: 30591290 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Brandy Maschhaupt, Clinical Project Manager
• Organization: Cordis Corp.

brandy.maschhaupt@cardinalhealth.com

847-887-5744

Study Officials

• Dierk Scheinert, PhD, MD.

  Universität Leipzig - Herzzentrum

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 19, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2016
• Last Updated: January 12, 2023
• Results First Posted: November 26, 2013

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)