A MULTICENTER, OPEN LABEL, PROSPECTIVE, NON-RANDOMIZED 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: December 31, 2014
Last verified: December 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
Abdominal aortic aneurysm 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 is a male or infertile female > 18 years of age
  2. Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures.
  3. Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
  4. Subject has at least one of the following:

    1. Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter
    2. Aneurysm, which is >4 cm and which has increased in size by 0.5 cm within 6 months
    3. The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter
    4. Saccular aneurysm
  5. Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr
  6. Subject aortic aneurysm neck is ≥15 mm in length
  7. Subject iliac landing zone≥10mm in length
  8. Subject has distal iliac landing sites with diameter ranges of 9-18mm
  9. Subject proximal aortic attachment is between 20-27 mm in diameter.
  10. Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm.
  11. Subject is willing to comply with all specified follow-up evaluations.

EXCLUSION CRITERIA:

  1. Subject has one of the following:

    1. a dissecting or inflammatory aneurysm
    2. acutely ruptured aneurysm
    3. pararenal or leaking aneurysm
  2. The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis
  3. Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm
  4. Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones
  5. Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta
  6. Subject has aneurysm neck angulations that are >60° in the supra-renal and/or infra-renal locations
  7. Aortic bifurcation ≤18mm in diameter
  8. Acute vascular injury due to trauma
  9. Subject has a known allergy to contrast medium
  10. Subject has known allergy to nitinol, PET or PTFE
  11. Subject has a need for emergent surgery
  12. Subject has a contraindication to undergoing angiography
  13. Subject has a thoracic aortic aneurysm that requires treatment
  14. Subject has Infra-renal aortic dissection
  15. Subject has an Iliac anatomy which would require occlusion of both internal iliac arteries
  16. Subject has congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated (e.g. angiography or CT) prior to treatment
  17. Subject has unstable angina as defined by Braunwald angina classification
  18. Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely inhibit visualization of the aorta
  19. Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome)
  20. Subject has known bleeding or hypercoagulable disorder
  21. Subject has contraindication for anticoagulation
  22. Subject with Stroke or MI or intracranial bleeding within 3 months prior to the procedure
  23. Subject with renal insufficiency (creatinine > 2.0 mg/dl)
  24. Subject has known or suspected active infection at the time of the index procedure (for ex. Pneumonia, acute virus infection, contaminated wounds etc)
  25. Subject is currently taking systemic immunosuppressant therapy
  26. Subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure
  27. Subject has a life expectancy less than 2 years
  28. Subject is currently participating in another research study involving an investigational device or new drug
  29. Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment
  30. Subject with an existing AAA surgical graft and/or a AAA stent-graft system
  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:
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: December 31, 2014
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Cordis Corporation:
Abdominal aortic aneurysm
AAA
Safety
Performance
Stent graft system
First in Human
Endovascular repair

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

ClinicalTrials.gov processed this record on May 25, 2015