A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION) (INSPIRATION)
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|ClinicalTrials.gov Identifier: NCT01664078|
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : August 10, 2020
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Device: Endovascular AAA repair with InCraft®||Not Applicable|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)|
|Actual Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 10, 2018|
Experimental: InCraft® - AAA stent graft system
Intervention: Endovascular AAA repair using the InCraft device
Device: Endovascular AAA repair with InCraft®
- Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate [ Time Frame: 30 days post-procedure ]
defined as a composite of:
- Myocardial Infarction
- New Onset Renal Failure (requiring dialysis)
- Respiratory Failure (requires mechanical ventilation)
- Bowel ischemia (requiring surgical intervention)
- Procedural blood loss ≥1,000 cc
- Number of Participants With 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.
- Procedure-related Complications [ Time Frame: Through 1 month, 180-days, 360-days and annually to 5-years post-procedure ]Adverse events that are a result of the procedure itself.
- 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: through 5 years ]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 ]The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.
- Length of Hospital Stay (Days) Post Index Procedure [ Time Frame: up to 17 days ]
- Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure [ Time Frame: up to 48 hours ]
- Length of the Index Procedure (Minutes) [ Time Frame: 1 day ]
- Pain Post-Operatively [ Time Frame: Baseline, 1 month, 6 months and 1 year post-procedure ]Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
- Physical Functioning Post-operatively [ Time Frame: Screening, 1 month, 6 months and 1 year post-procedure ]Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664078
|United States, Pennsylvania|
|Michel S. Makaroun, MD|
|Pittsburgh, Pennsylvania, United States, 15217|
|Takao Ohki, MD|
|Minato-ku, Tokyo, Japan, 105-8461|
|Principal Investigator:||Michel S Makaroun, MD||University of Pittsburgh|
|Principal Investigator:||Takao Ohki, MD||Jikei University School of Medicine|