LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair

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Brief Title

LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair

Official Title

The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair

Brief Summary

      The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center
      post-market registry to evaluate the low profile Ovation ® Abdominal Stent Graft Platform
      when used in the endovascular treatment of female patients.
    

Detailed Description

      The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center
      post-market registry to evaluate the Ovation Abdominal Stent Graft Platform when used in the
      endovascular treatment of female patients.

      The primary endpoint is the Major Adverse Event (MAE) rate within 30 days of the initial
      procedure. MAEs will be adjudicated and reported based upon an independent Clinical Events
      Committee (CEC).

      Secondary endpoints of the study will be achieved by demonstrating the benefits in female
      patients (Treatment Group) are comparable to male patients (Control Group) despite the fact
      that historically fewer female patients have been eligible for EVAR, and they have
      experienced a higher rate of access-related complications and higher mortality rates.
      Secondary endpoints will be evaluated through 1 year (365 ± 60 days) post-procedure.

      A maximum of 45 sites across the United States are expected to enroll 225 subjects (75
      females in the Treatment Group and 150 males in the Control Group).
    


Study Type

Observational [Patient Registry]


Primary Outcome

Major Adverse Event (MAE)

Secondary Outcome

 Serious and Non-Serious Adverse Events

Condition

Abdominal Aortic Aneurysm

Intervention

Ovation Abdominal Stent Graft Platform

Study Arms / Comparison Groups

 Female (Treatment Group)
Description:  Device: Ovation Abdominal Stent Graft Platform

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

225

Start Date

August 2015

Completion Date

August 2018

Primary Completion Date

September 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Patient is > 18 years of age.

          2. Patients who are male or non-pregnant female (females of child bearing potential must
             have a negative pregnancy test prior to enrollment into the study).

          3. Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form.

          4. Patient is considered by the treating physician to be a candidate for elective open
             surgical repair of the AAA (i.e., category I, II, or III per American Society of
             Anesthesiology (ASA) classification; refer to Appendix II: ASA Classification System).
             ASA category IV patients may be enrolled provided their life expectancy is greater
             than 1 year.

          5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the
             following:

               1. Abdominal aortic aneurysm >5.0 cm in diameter;

               2. Aneurysm has increased in size by 0.5 cm in last 6 months; or

               3. Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an
                  adjacent non-aneurysmal aortic segment.

          6. Patient has suitable anatomy that allows use of the TriVascular Ovation Abdominal
             Platform:

               1. Iliac or femoral arteries that allow endovascular access with the TriVascular
                  Ovation Abdominal Platform.

               2. Proximal aortic neck landing zone with an inner wall diameter of no less than 16
                  mm and no greater than 30 mm at 13 mm below the inferior renal artery.

               3. Distal iliac artery landing zone length (seal zone) of ≥10 mm. The resultant
                  repair should preserve patency in at least one hypogastric artery.

               4. Distal iliac artery landing zone an inner wall diameter of no less than 8 mm and
                  no greater than 25 mm.

               5. Distance from the most distal renal artery to most superior internal iliac artery
                  measurement is at least 130 mm.

               6. Aortic angle of ≤ 60 degrees if proximal neck length is ≥10 mm and ≤ 45 degrees
                  if proximal neck length is <10 mm.

          7. Patient must be willing to comply with all required follow-up exams.

        Exclusion Criteria

          1. Patient has a need for emergent surgery.

          2. Patient has a dissecting aneurysm.

          3. Patient has an acutely ruptured aneurysm.

          4. Patient has an acute vascular injury.

          5. Patient has had a previous repair of the abdominal aortic aneurysm or an iliac artery
             in intended treatment zone.

          6. Patient has a known thoracic aortic aneurysm or dissection that will require treatment
             (surgery or endovascular intervention) within the study period.

          7. Patient has a mycotic aneurysm or has an active systemic infection.

          8. Patient has unstable angina (defined as angina with a progressive increase in
             symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina).

          9. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6
             months.

         10. Patient requires use of techniques (e.g. Chimney graft) that would cover the renal
             arteries.

         11. Patient requires planned adjunctive devices (e.g. renal stents) to complete the
             procedure.

         12. Patient has a major surgical or interventional procedure planned during or within ±30
             days of the AAA repair.

         13. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos
             syndrome).

         14. Patient has history of bleeding disorders or refuses blood transfusions.

         15. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0
             mg/dl

         16. Patient has a known hypersensitivity or contraindication to anticoagulation or
             contrast media that is not amenable to pre-treatment.

         17. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE),
             PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.

         18. Patient has a body habitus that would inhibit X-ray visualization of the aorta.

         19. Patient has a limited life expectancy of less than 1 year.

         20. Patient is currently participating in an investigational device or drug clinical
             trial.

         21. Patient has other medical, social or psychological conditions that, in the opinion of
             the investigator, preclude them from receiving the pre-treatment, required treatment,
             and post-treatment procedures and evaluations.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jennifer Ash, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02479191

Organization ID

771-0016


Responsible Party

Sponsor

Study Sponsor

TriVascular, Inc.


Study Sponsor

Jennifer Ash, MD, Study Chair, Christie Clinic Vein & Vascular Center


Verification Date

April 2017