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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
New England Research Institutes
Quintiles
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT01664078
First received: August 9, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Abdominal Aortic Aneurysm
Device: Endovascular AAA repair
Phase 3

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Incidence of MAE (major adverse events) based upon a composite MAE rate. [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
  • Successful aneurysm treatment [ Time Frame: Up to 1 year post-procedure ] [ Designated as safety issue: No ]

    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:
  • Procedure-related complications [ Time Frame: Through 30-days, 180-days, 360-days and annually to 5-years post-procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Incidence of secondary interventions [ Time Frame: Within 1 year post-procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Device-related events [ Time Frame: At 1 month, 6 months, 1 year and annually to 5-years post-procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Incidence or need for secondary intervention [ Time Frame: At 1 month, 6 months, 1 year and annually through 5-years post-procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Length of Intensive Care Unit (ICU) stay (hours) post index procedure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Length of the Index procedure (minutes) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pain post-operatively compared to external cohort [ Time Frame: Screening, 1 month, 6 months and 1 year post-procedure ] [ Designated as safety issue: No ]
  • Physical functioning post-operatively compared to external cohort [ Time Frame: Screening, 1 month, 6 months and 1 year post-procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: July 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: InCraft® - AAA stent graft system
Endovascular AAA repair
Device: Endovascular AAA repair

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664078

Locations
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
New England Research Institutes
Quintiles
Investigators
Principal Investigator: Michel S Makaroun, MD University of Pittsburgh
Principal Investigator: Takao Ohki, MD Jikei University School of Medicine
  More Information

No publications provided

Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01664078     History of Changes
Other Study ID Numbers: P11-4601
Study First Received: August 9, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cordis Corporation:
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 01, 2014