Compassionate Use of the Incraft® AAA Stent Graft System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01776450
Expanded Access Status : Available
First Posted : January 28, 2013
Last Update Posted : January 1, 2015
Information provided by (Responsible Party):
Cordis Corporation

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

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Device: Endovascular AAA repair

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.

Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Compassionate Use of the Incraft® AAA Stent Graft System
Study Start Date : November 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01776450

Contact: Susan Hinz 510-248-2628

United States, California
Cordis Corporation
Fremont, California, United States, 94555
Contact: Susan Hinz    510-248-2628   
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: Michel S Makaroun, MD University of Pittsburgh
Principal Investigator: Takao Ohki, MD Jikei University School of Medicine

Responsible Party: Cordis Corporation Identifier: NCT01776450     History of Changes
Other Study ID Numbers: G120003/S4
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: December 2014

Keywords provided by Cordis Corporation:
Abdominal Aortic Aneurysm

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