Clinical trial NCT01664078: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: Carelon Research
name: Quintiles, Inc.
First posted: 2012-08-14
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate
timeFrame: 30 days post-procedure
measure: Number of Participants With Successful Aneurysm Treatment
timeFrame: Up to 1 year post-procedure
Secondary outcomes:
measure: Procedure-related Complications
timeFrame: Through 1 month, 180-days, 360-days and annually to 5-years post-procedure
measure: Aneurysm-related Mortality
timeFrame: At 30-days, 180-days, 360-days and annually to 5-years post-procedure
measure: Incidence of Secondary Interventions
timeFrame: through 5 years
measure: Major Adverse Events (MAEs) and Individual Components of the MAEs
timeFrame: At 180-days, 360-days and annually to 5-years post-procedure
measure: Device-related Events
timeFrame: At 1 month, 6 months, 1 year and annually to 5-years post-procedure
measure: Technical Success Confirmed by CT or Other Imaging Modality
timeFrame: At 30-days
measure: Length of Hospital Stay (Days) Post Index Procedure
timeFrame: up to 17 days
measure: Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure
timeFrame: up to 48 hours
measure: Length of the Index Procedure (Minutes)
timeFrame: 1 day
Other outcomes:
measure: Pain Post-Operatively
timeFrame: Baseline, 1 month, 6 months and 1 year post-procedure
measure: Physical Functioning Post-operatively
timeFrame: Screening, 1 month, 6 months and 1 year post-procedure
Locations:
city: Pittsburgh
country: United States
facility: Michel S. Makaroun, MD
state: Pennsylvania
city: Minato-ku
country: Japan
facility: Takao Ohki, MD
state: Tokyo
Study officials:
affiliation: University of Pittsburgh
name: Michel S Makaroun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jikei University School of Medicine
name: Takao Ohki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iantorno M, Buchanan KD, Bernardo NL, Torguson R, Waksman R. Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System. Cardiovasc Revasc Med. 2019 May;20(5):403-408. doi: 10.1016/j.carrev.2019.02.018. Epub 2019 Feb 18.