TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT02703428
• Lead Sponsor: TriVascular, Inc.

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Primary Completion: 2019-02
• Study Completion: 2019-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.	30 ± 10 days

Secondary Outcome Measures

Name	Time	Method
Freedom from conversion to open repair	365 ± 60 days	Conversion to open surgical repair occurs when a subject implanted with an Ovation Abdominal Platform undergoes open surgical repair with explantation of the stent graft.
Anesthesia Type	365 ± 60 days
Serious and Non-Serious Adverse Events	365 ± 60 days
Access-related vascular complications	365 ± 60 days
Freedom from Abdominal Aortic Aneurysm rupture	365 ± 60 days
Freedom from Type I & III endoleaks	365 ± 60 days
Length of hospital and ICU (if required)	365 ± 60 days
Freedom from migration	365 ± 60 days
Technical (deployment) success	365 ± 60 days	Defined as successful delivery and deployment of one aortic body and at least two iliac limbs.
Freedom from aneurysm enlargement	365 ± 60 days
Freedom from AAA related secondary interventions	365 ± 60 days
Freedom from mortality (all cause and AAA related)	365 ± 60 days
Blood Loss	365 ± 60 days	Estimate blood loss and replacement requirements, (e.g. transfusion).
Duration of Procedure	365 ± 60 days	Time enter procedure room, time start arterial access, stent graft deployment start and stop time, time of closure of arterial access, and time exit procedure room.

Trial Locations

Locations (10)

University of Düsseldorf; 🇩🇪 Düsseldorf, Germany

August Krankenhaus; 🇩🇪 Dusseldorf, Germany

OLV Ziekhenuis; 🇧🇪 Aalst, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

HGZ Bad Bevensen; 🇩🇪 Bad Bevensen, Germany

University of Leipzig; 🇩🇪 Leipzig, Germany

Institute of Hematology and Blood Transfusion; 🇵🇱 Warsaw, Poland

Hospital Karlsruhe; 🇩🇪 Karlsruhe, Germany

University Medical Center Hamburg; 🇩🇪 Hamburg, Germany

Bedfordshire Hospitals NHS Trust; 🇬🇧 Bedford, United Kingdom