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Compassionate Use of the Incraft® AAA Stent Graft System

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Disease Information

Descriptive Information
Brief Title † Compassionate Use of the Incraft® AAA Stent Graft System
Official Title † Compassionate Use of the Incraft® AAA Stent Graft System
Brief Summary To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of the clinical protocol through compassionate use.
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 Phase N/A
Study Type † Expanded Access
Study Design † N/A
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceEndovascular AAA repair
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment †
Start Date † November 2012
Completion Date August 2018
Primary Completion Date August 2018
Eligibility 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.
Gender Both
Ages N/A - N/A
Accepts Healthy Volunteers No
Contacts †† Susan Hinz, 510-248-2628, shinz@its.jnj.com
Location Countries † United States
Administrative Information
NCT ID † NCT01776450
Organization ID G120003/S4
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Cordis Corporation
Collaborators ††
Investigators † Principal Investigator: Michel S Makaroun, MD, University of Pittsburgh
Information Provided By
Verification Date December 2014
First Received Date † January 21, 2013
Last Updated Date December 31, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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