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Compassionate Use of the Incraft® AAA Stent Graft System

Expanded access is currently available for this treatment.
Verified February 2014 by Cordis Corporation
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT01776450
First received: January 21, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of the clinical protocol through compassionate use.


Condition Intervention
Abdominal Aortic Aneurysm
Device: Endovascular AAA repair

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of the Incraft® AAA Stent Graft System

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Study Start Date: November 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Detailed Description:

In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths. The most significant complication of AAA is an aneurysm sac rupture from which more than 15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to 85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm repair (EVAR) and open surgical repair cases were performed in the year 2010 .

Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an alternative treatment of AAA for most patients. It is less invasive than open repair and carries lower rates of early mortality and morbidity . It has also extended treatment options to patients who cannot undergo conventional surgical procedures due to a high operative risk. As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the aortic neck and access vessels.

The InCraft ®AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, which assists the physician in deploying the device in a controlled, consistent, and precise manner within the aortic neck and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and the potential for aneurysm sac rupture.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Obtain an independent assessment by an uninvolved physician.
  2. Obtain informed consent from the patient or legal representative. The consent form used should provide information pertinent to the patient's specific situation. (If appropriate, the study consent form may be used with an addendum to inform the patient of concerns specific to their situation.)
  3. Obtain clearance from the institution in accordance with their policies.
  4. Notify the institutional review board and comply with their procedures.
  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: NCT01776450

Contacts
Contact: Amy Orlick 908-541-4347 aorlick@its.jnj.com

Locations
United States, New Jersey
Cordis Corporation
Bridgewater, New Jersey, United States, 08807
Contact: Amy Orlick    908-541-4347    aorlick@its.jnj.com   
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Michel S Makaroun, MD University of Pittsburgh
Principal Investigator: Takao Ohki, MD Jikei University School of Medicine
  More Information

No publications provided

Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01776450     History of Changes
Other Study ID Numbers: G120003/S4
Study First Received: January 21, 2013
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cordis Corporation:
Abdominal Aortic Aneurysm

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

ClinicalTrials.gov processed this record on November 20, 2014