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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) (INSPIRATION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01664078
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Collaborators:
HealthCore-NERI
Quintiles, Inc.
Information provided by (Responsible Party):
Cordis Corporation

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.

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 ...

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 : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: InCraft® - AAA stent graft system
Intervention: Endovascular AAA repair using the InCraft device
Device: Endovascular AAA repair with InCraft®



Primary Outcome Measures :
  1. 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:

    • 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Aneurysm-related Mortality [ Time Frame: At 30-days, 180-days, 360-days and annually to 5-years post-procedure ]
  3. 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.

  4. Major Adverse Events (MAEs) and Individual Components of the MAEs [ Time Frame: At 180-days, 360-days and annually to 5-years post-procedure ]
  5. 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.

  6. 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.

  7. Length of Hospital Stay (Days) Post Index Procedure [ Time Frame: up to 17 days ]
  8. Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure [ Time Frame: up to 48 hours ]
  9. Length of the Index Procedure (Minutes) [ Time Frame: 1 day ]

Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must meet ALL of the following inclusion criteria to be enrolled in the study:

    1. Male or Female age 20 years or older;
    2. Proximal aortic neck is 17-31mm in diameter;
    3. Supra-renal aorta, at 20mm above the anticipated landing location, is smaller than the nominal diameter of the aortic bifurcate prosthesis to be used;
    4. Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal angulations ≤60°;
    5. Subject has at least one of the following:

      1. AAA size > 5.0 cm;
      2. Increase of the AAA diameter of > 0.5 cm over the last 6 months;
    6. Abdominal treatment length (lowest renal artery origin to the aortic bifurcation) ≥ 9.4cm;
    7. Aortic bifurcation >18mm in diameter;
    8. Iliac landing zone ≥15mm in length;
    9. Iliac landing zone 7-22mm in diameter;
    10. Minimum access vessel size of ≥ 5mm;
    11. Minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 128 mm;
    12. 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;
    13. Provide written informed consent and as applicable written HIPAA authorization (For US sites only) prior to initiation of study procedures;
    14. Willing to comply with the specified follow-up evaluation schedule.

Exclusion Criteria:

  • Subjects will be excluded if ANY of the following exclusion criteria apply:

    1. 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;
    2. Subject has one of the following:

      1. Aneurysm sac rupture or leaking abdominal aortic aneurysm;
      2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
      3. Clinically significant acute vascular injury due to trauma;
    3. Significant aortic or iliac mural thrombus, plaque or calcification that would compromise fixation and seal of the device;
    4. A conical aortic neck defined as >3mm distal increase over a 10mm length in the planned seal zone;
    5. Thoracic aortic aneurysm ≥45mm;
    6. Any aortic dissection;
    7. Morbid obesity (BMI >40.0 kg.m2) or other clinical conditions that limit required imaging studies or visualization of the aorta;
    8. Renal insufficiency (Creatinine > 2.0mg/dL) or subject on renal dialysis;
    9. Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE);
    10. Known contraindication to undergoing angiography or anticoagulation (e.g. contrast allergies which cannot be treated);
    11. Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome);
    12. Coagulopathy, bleeding disorder, or other hypercoagulable state;
    13. Organ transplant recipient or subject requiring systemic immunosuppressant therapy;
    14. Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months prior to the procedure;
    15. Active infection or chronic systemic illness at the time of index procedure that may interfere with the study objectives;
    16. Major surgical procedure within 1 month prior to the index procedure or pre-planned within 1 month afterwards;
    17. Co-existing condition with a life expectancy of less than 2 years at time of procedure;
    18. Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation;
    19. Existing AAA surgical graft and/or a AAA stent-graft system;
    20. 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.

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Michel S. Makaroun, MD
Pittsburgh, Pennsylvania, United States, 15217
Japan
Takao Ohki, MD
Minato-ku, Tokyo, Japan, 105-8461
Sponsors and Collaborators
Cordis Corporation
HealthCore-NERI
Quintiles, Inc.
Investigators
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Principal Investigator: Michel S Makaroun, MD University of Pittsburgh
Principal Investigator: Takao Ohki, MD Jikei University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01664078    
Other Study ID Numbers: P11-4601
First Posted: August 14, 2012    Key Record Dates
Results First Posted: August 10, 2020
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cordis Corporation:
Abdominal Aortic Aneurysm
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases