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

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Brief Title

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

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 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.
    


Study Type

Interventional


Primary Outcome

Incidence of MAE (major adverse events) based upon a composite MAE rate.

Secondary Outcome

 Procedure-related complications

Condition

Abdominal Aortic Aneurysm

Intervention

Endovascular AAA repair with InCraft®

Study Arms / Comparison Groups

 InCraft® - AAA stent graft system
Description:  Intervention: Endovascular AAA repair using the InCraft device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

190

Start Date

July 2012

Completion Date

June 2019

Primary Completion Date

October 2014

Eligibility 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.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michel S Makaroun, MD, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01664078

Organization ID

P11-4601


Responsible Party

Sponsor

Study Sponsor

Cordis Corporation

Collaborators

 HealthCore-NERI

Study Sponsor

Michel S Makaroun, MD, Principal Investigator, University of Pittsburgh


Verification Date

January 2018