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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
  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:

U.S. FDA Resources

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

Locations
Germany
Universität Leipzig - Herzzentrum
Leipzig, Germany
Sponsors and Collaborators
Cordis Corporation
Investigators
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: February 12, 2013
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 May 16, 2013