Compassionate Use of the Incraft AAA Stent Graft System
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| First Received Date ICMJE | January 21, 2013 | ||||||||
| Last Updated Date | January 23, 2013 | ||||||||
| Start Date ICMJE | November 2012 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01776450 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Compassionate Use of the Incraft AAA Stent Graft System | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Expanded Access | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Condition ICMJE | Abdominal Aortic Aneurysm | ||||||||
| Intervention ICMJE | Device: Endovascular AAA repair | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Available | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Estimated Completion Date | May 2018 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01776450 | ||||||||
| Other Study ID Numbers ICMJE | G120003/S4 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Cordis Corporation | ||||||||
| Study Sponsor ICMJE | Cordis Corporation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Cordis Corporation | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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