Clinical trial NCT02703428: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
Official title: The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal
Aortic
Aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
Collaborators: name: Endologix
First posted: 2016-03-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll female subjects, 18 years of age or older that have an AAA and meet all other inclusion/exclusion criteria

Brief summary: The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market study to evaluate the low profile (14F) 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 study to evaluate the Ovation Abdominal Platform when used in the endovascular treatment of female patients.

The primary endpoint is freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.

Secondary endpoints of the study will be achieved by demonstrating the benefits in female patients 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.

Eligibility criteria: Inclusion Criteria:

1. Patient is \> 18 years of age.
2. Patients who are 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 Ethics Committee (EC) 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). 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:

   * Abdominal aortic aneurysm \>5.0 cm in diameter;
   * Aneurysm has increased in size by 0.5 cm in last 6 months; or
   * 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:

   * Iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Platform.
   * 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.
   * Distal iliac artery landing zone length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
   * Distal iliac artery landing zone an inner wall diameter of no less than 8 mm and no greater than 25 mm.
   * Distance from the most distal renal artery to most superior internal iliac artery measurement is at least 130 mm.
   * 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.

Primary outcomes:
measure: Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.
timeFrame: 30 ± 10 days
Secondary outcomes:
measure: Serious and Non-Serious Adverse Events
timeFrame: 365 ± 60 days
measure: Access-related vascular complications
timeFrame: 365 ± 60 days
measure: Technical (deployment) success
timeFrame: 365 ± 60 days
measure: Freedom from Type I & III endoleaks
timeFrame: 365 ± 60 days
measure: Freedom from migration
timeFrame: 365 ± 60 days
measure: Freedom from aneurysm enlargement
timeFrame: 365 ± 60 days
measure: Freedom from Abdominal Aortic Aneurysm rupture
timeFrame: 365 ± 60 days
measure: Freedom from conversion to open repair
timeFrame: 365 ± 60 days
measure: Freedom from AAA related secondary interventions
timeFrame: 365 ± 60 days
measure: Freedom from mortality (all cause and AAA related)
timeFrame: 365 ± 60 days
measure: Blood Loss
timeFrame: 365 ± 60 days
measure: Duration of Procedure
timeFrame: 365 ± 60 days
measure: Length of hospital and ICU (if required)
timeFrame: 365 ± 60 days
measure: Anesthesia Type
timeFrame: 365 ± 60 days
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekhenuis
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bad Bevensen
country: Germany
facility: HGZ Bad Bevensen
city: Dusseldorf
country: Germany
facility: August Krankenhaus
city: Düsseldorf
country: Germany
facility: University of Düsseldorf
city: Hamburg
country: Germany
facility: University Medical Center Hamburg
city: Karlsruhe
country: Germany
facility: Hospital Karlsruhe
city: Leipzig
country: Germany
facility: University of Leipzig
city: Warsaw
country: Poland
facility: Institute of Hematology and Blood Transfusion
city: Bedford
country: United Kingdom
facility: Bedfordshire Hospitals NHS Trust
Study officials:
affiliation: Augusta Krankenhaus
name: Ralf Kolvenbach, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: