A Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms (INNOVATION)

A Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms (INNOVATION)
This study is ongoing, but not recruiting participants.

First Received on April 16, 2010.  
Last Updated on May 14, 2012  
History of Changes
Sponsor: Cordis Corporation
Information provided by (Responsible Party): Cordis Corporation
ClinicalTrials.gov Identifier: NCT01106391

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.

Condition Intervention Phase
Abdominal Aortic Aneurysms Device: Cordis AAA stent graft system "INCRAFT TM" Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms

Resource links provided by NLM:

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

  • Technical success will be defined by 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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Safety will be defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events (death, MI, stroke and renal failure) within 1 month post-procedure. [ Time Frame: 1 month follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: June 2016
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)


Assigned Interventions
Experimental: AAA stent graft system

AAA stent graft system
Device: Cordis AAA stent graft system "INCRAFT TM"


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures.
  2. Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.

The INCRAFT Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including:

  1. Adequate iliac/femoral access compatible with the required delivery systems
  2. Non-aneurysmal proximal aortic neck, and
  3. Non-aneurysmal distal iliac landing zone.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106391

Universität Leipzig – Herzzentrum
Leipzig, Germany
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: Dierk Scheinert, PhD, MD. Universität Leipzig – Herzzentrum
  More Information

No publications provided

Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01106391    
History of Changes
Other Study ID Numbers: EE09-01
Study First Received: April 16, 2010
Last Updated: May 14, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Cordis Corporation:

Abdominal Aortic aneurysm
stent graft system

Additional relevant MeSH terms:

Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 21, 2012

Leave a Reply

You can use these HTML tags

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>




four × 2 =