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
  Purpose

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:
  • 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.


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)
Arms Assigned Interventions
Experimental: AAA stent graft system
AAA stent graft system
Device: Cordis AAA stent graft system "INCRAFT TM"

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01106391     History of Changes
Other Study ID Numbers: EE09-01
Study First Received: April 16, 2010
Results First Received: September 23, 2013
Last Updated: January 2, 2014
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Cordis Corporation:
Abdominal Aortic aneurysm
AAA
safety
efficacy
stent graft system
FIH

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 24, 2014