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

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

Detailed Description
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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.

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Endovascular AAA repair with InCraft®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must meet ALL of the following inclusion criteria to be enrolled in the study: Male or Female age 20 years or older; Proximal aortic neck is 17-31mm in diameter; Supra-renal aorta, at 20mm above the anticipated landing location, is smaller than the nominal diameter of the aortic bifurcate prosthesis to be used; Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal angulations ≤60°; Subject has at least one of the following: AAA size > 5.0 cm; Increase of the AAA diameter of > 0.5 cm over the last 6 months; Abdominal treatment length (lowest renal artery origin to the aortic bifurcation) ≥ 9.4cm; Aortic bifurcation >18mm in diameter; Iliac landing zone ≥15mm in length; Iliac landing zone 7-22mm in diameter; Minimum access vessel size of ≥ 5mm; Minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 128 mm; Women of child bearing potential must be non-pregnant, non-lactating, and not planning to become pregnant during the course of the trial; and have a negative urine or serum pregnancy test within 7 days prior to index procedure; Provide written informed consent and as applicable written HIPAA authorization (For US sites only) prior to initiation of study procedures; Willing to comply with the specified follow-up evaluation schedule. Exclusion Criteria: Subjects will be excluded if ANY of the following exclusion criteria apply: Vascular anatomy in which the placement of the stent-graft will cause occlusion of both internal iliac arteries or necessitates surgical occlusion of both internal iliac arteries; Subject has one of the following: Aneurysm sac rupture or leaking abdominal aortic aneurysm; Mycotic, dissecting, or inflammatory abdominal aortic aneurysm; Clinically significant acute vascular injury due to trauma; Significant aortic or iliac mural thrombus, plaque or calcification that would compromise fixation and seal of the device; A conical aortic neck defined as >3mm distal increase over a 10mm length in the planned seal zone; Thoracic aortic aneurysm ≥45mm; Any aortic dissection; Morbid obesity (BMI >40.0 kg.m2) or other clinical conditions that limit required imaging studies or visualization of the aorta; Renal insufficiency (Creatinine > 2.0mg/dL) or subject on renal dialysis; Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE); Known contraindication to undergoing angiography or anticoagulation (e.g. contrast allergies which cannot be treated); Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome); Coagulopathy, bleeding disorder, or other hypercoagulable state; Organ transplant recipient or subject requiring systemic immunosuppressant therapy; Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months prior to the procedure; Active infection or chronic systemic illness at the time of index procedure that may interfere with the study objectives; Major surgical procedure within 1 month prior to the index procedure or pre-planned within 1 month afterwards; Co-existing condition with a life expectancy of less than 2 years at time of procedure; Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation; Existing AAA surgical graft and/or a AAA stent-graft system; Other medical, social, or psychological issues that in the opinion of the investigator preclude the subjects from receiving this treatment, and the procedures and evaluations pre- and posttreatment.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InCraft® - AAA stent graft system<br>Intervention: Endovascular AAA repair using the InCraft device | Device: Endovascular AAA repair with InCraft®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate | defined as a composite of: Death Stroke Myocardial Infarction New Onset Renal Failure (requiring dialysis) Respiratory Failure (requires mechanical ventilation) Paralysis/paraparesis Bowel ischemia (requiring surgical intervention) Procedural blood loss ≥1,000 cc | 30 days post-procedure | 
| Number of Participants With Successful Aneurysm Treatment | 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. | Up to 1 year post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related Complications | Adverse events that are a result of the procedure itself. | Through 1 month, 180-days, 360-days and annually to 5-years post-procedure | 
| Aneurysm-related Mortality |  | At 30-days, 180-days, 360-days and annually to 5-years post-procedure | 
| Incidence of Secondary Interventions | 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. | through 5 years | 
| Major Adverse Events (MAEs) and Individual Components of the MAEs |  | At 180-days, 360-days and annually to 5-years post-procedure | 
| Device-related Events | 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. | At 1 month, 6 months, 1 year and annually to 5-years post-procedure | 
| Technical Success Confirmed by CT or Other Imaging Modality | 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. | At 30-days | 
| Length of Hospital Stay (Days) Post Index Procedure |  | up to 17 days | 
| Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure |  | up to 48 hours | 
| Length of the Index Procedure (Minutes) |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm