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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

January 21, 2013
February 6, 2014
November 2012
August 2018   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01776450 on ClinicalTrials.gov Archive Site
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Compassionate Use of the Incraft® AAA Stent Graft System
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
Not Provided
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Abdominal Aortic Aneurysm
Device: Endovascular AAA repair
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
Not Provided
August 2018
August 2018   (final data collection date for primary outcome measure)
  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.
Both
Not Provided
No
Contact: Amy Orlick 908-541-4347 aorlick@its.jnj.com
United States
 
NCT01776450
G120003/S4
No
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
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP