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Compassionate Use of the Incraft® AAA Stent Graft System

Expanded access is currently available for this treatment.
Verified December 2014 by Cordis Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776450
First Posted: January 28, 2013
Last Update Posted: January 1, 2015
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.
Information provided by (Responsible Party):
Cordis Corporation
January 21, 2013
January 28, 2013
January 1, 2015
 
Compassionate Use of the Incraft® AAA Stent Graft System
To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of the clinical protocol through compassionate use.

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.

Expanded Access
Device: Endovascular AAA repair
Not Provided
 
Available
Contact: Susan Hinz 510-248-2628 shinz@its.jnj.com
United States
 
 
NCT01776450
Cordis Corporation
Cordis Corporation
Not Provided
Principal Investigator: Michel S Makaroun, MD University of Pittsburgh
Principal Investigator: Takao Ohki, MD Jikei University School of Medicine
Cordis Corporation
December 2014