Clinical Trial: A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.

Detailed Summary:

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.

Current Primary Outcome:

• Incidence of MAE (major adverse events) based upon a composite MAE rate. [ Time Frame: 30 days post-procedure ]
• Successful aneurysm treatment [ Time Frame: Up to 1 year post-procedure ]

  Successful aneurysm treatment which is a composite endpoint of the following:

  • Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality;
  • Absence of post-operative aneurysm enlargement (growth > 5 mm) or stent graft migration (> 10mm) compared to the one month size measurement at anytime up to 1-year;
  • Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.

Original Primary Outcome:

Current Secondary Outcome:

• Procedure-related complications [ Time Frame: Through 30-days, 180-days, 360-days and annually to 5-years post-procedure ]
  Adverse events that are a result of the procedure itself. They will be analyzed and reported for INCRAFT® subjects only (no comparison to SVS Surgical Controls).
• Aneurysm-related mortality [ Time Frame: At 30-days, 180-days, 360-days and annually to 5-years post-procedure ]
• Incidence of secondary interventions [ Time Frame: Within 1 year post-procedure ]
  The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
• Major Adverse Events (MAEs) and individual components of the MAEs [ Time Frame: At 180-days, 360-days and annually to 5-years post-procedure ]
• Device-related events [ Time Frame: At 1 month, 6 months, 1 year and annually to 5-years post-procedure ]
  Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement,
• Technical success confirmed by CT or other imaging modality; [ Time Frame: At 30-days ]
• Incidence or need for secondary intervention [ Time Frame: At 1 month, 6 months, 1 year and annually through 5-years post-procedure ]
  Incidence of secondary intervention or the need for secondary interventions, to repair vascular events or malfunctions which are related to device and/or peri-graft complications through 5-years. Secondary intervention is any vascular event which requires intervention to repair the AAA or device. Indications for secondary intervention may include endoleaks, stent graft migration, occlusion, or aneurysm sac rupture.
• Length of hospital stay (days) post index procedure [ Time Frame: 1 day ]
• Length of Intensive Care Unit (ICU) stay (hours) post index procedure [ Time Frame: 1 day ]
• Length of the Index procedure (minutes) [ Time Frame: 1 day ]

Original Secondary Outcome:

Information By: Cordis Corporation

Dates:
Date Received: August 9, 2012
Date Started: July 2012
Date Completion: October 2018
Last Updated: November 16, 2016
Last Verified: November 2016