Compassionate Use of the Incraft® AAA Stent Graft System
| Status: | Available |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | November 2012 |
| End Date: | August 2018 |
| Contact: | Susan Hinz |
| Email: | shinz@its.jnj.com |
| Phone: | 510-248-2628 |
To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of
the clinical protocol through compassionate use.
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.
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.
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.
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