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: January 2, 2014
Last verified: January 2014

April 16, 2010
January 2, 2014
March 2010
August 2011   (final data collection date for primary outcome measure)
  • Rate of Technical Success Through the One Month Follow up. [ Time Frame: From procedure to one month follow up ] [ Designated as safety issue: No ]
    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.
  • Rate of Primary Safety Endpoint Within 1 Month Post-procedure. [ Time Frame: One month follow-up ] [ Designated as safety issue: Yes ]
    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.
  • Safety will be defined by the absence of device and/or procedural related Types I, III or IV endoleaks and 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 ]
  • 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 ]
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"

*   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
January 2014

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