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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT01106391
First received: April 16, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes

April 16, 2010
February 12, 2013
March 2010
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01106391 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms (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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysms
Device: Cordis AAA stent graft system "INCRAFT TM"
Experimental: AAA stent graft system
AAA stent graft system
Intervention: Device: Cordis AAA stent graft system "INCRAFT TM"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2016
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01106391
EE09-01
Yes
Cordis Corporation
Cordis Corporation
Not Provided
Principal Investigator: Dierk Scheinert, PhD, MD. Universität Leipzig - Herzzentrum
Cordis Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP