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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Ovation Abdominal Stent Graft Platform

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
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll male and female subjects 18 years of age and older that have an AAA and meet all other inclusion/exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Female (Treatment Group); Device: Ovation Abdominal Stent Graft Platform	Device: Ovation Abdominal Stent Graft Platform
Male (Control Group); Device: Ovation Abdominal Stent Graft Platform	Device: Ovation Abdominal Stent Graft Platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major Adverse Event (MAE)	1 month (30 ± 10 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious and Non-Serious Adverse Events		1 year (365 ± 60 days)
Access-related vascular complications		1 year (365 ± 60 days)
Technical (deployment) success		1 year (365 ± 60 days)
Freedom from Type I & III endoleaks		1 year (365 ± 60 days)
Freedom from migration		1 year (365 ± 60 days)
Freedom from aneurysm enlargement		1 year (365 ± 60 days)
Freedom from AAA rupture		1 year (365 ± 60 days)
Freedom from conversion to open repair		1 year (365 ± 60 days)
Freedom from AAA related secondary interventions		1 year (365 ± 60 days)
Freedom from mortality (all cause and AAA related)		1 year (365 ± 60 days)
Clinical Utility, including:	Blood loss, including if transfusion required, Duration of procedure, Length of hospital and ICU (if required) stay, Anesthesia type	1 year (365 ± 60 days)

Collaborators and Investigators

• Sponsor: TriVascular, Inc.
• Investigators: Study Chair: Jennifer Ash, MD, Christie Clinic Vein & Vascular Center; Study Chair: Venita Chandra, MD, Stanford School of Medicine; Study Chair: Eva Rzucidlo, MD, Geisel School of Medicine, Dartmouth; Study Chair: Ageliki Vouyouka, MD, Mount Sinai Hospital; Study Chair: Monica Hunter, MD, Ohio Heart and Vascular Center

Publications and helpful links

Helpful Links

• TriVascular Website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Aneurysm; Abdominal; Aortic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 771-0016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No