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

Completed

Conditions studied: Abdominal Aortic Aneurysm

In brief

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.

Key facts

Study ID

NCT02479191

Run by

TriVascular, Inc.

People needed

225

Starts

2015-08-01

Expected to finish

2019-09-30

Last updated by the study team

2021-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is > 18 years of age.
• 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).
• Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form.
• 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.
• 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.
• 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.
• Patient must be willing to comply with all required follow-up exams.

You may not qualify if…

• Patient has a need for emergent surgery.
• Patient has a dissecting aneurysm.
• Patient has an acutely ruptured aneurysm.
• Patient has an acute vascular injury.
• Patient has had a previous repair of the abdominal aortic aneurysm or an iliac artery in intended treatment zone.
• Patient has a known thoracic aortic aneurysm or dissection that will require treatment (surgery or endovascular intervention) within the study period.
• Patient has a mycotic aneurysm or has an active systemic infection.
• 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).
• Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
• Patient requires use of techniques (e.g. Chimney graft) that would cover the renal arteries.
• Patient requires planned adjunctive devices (e.g. renal stents) to complete the procedure.
• Patient has a major surgical or interventional procedure planned during or within ±30 days of the AAA repair.
• Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
• Patient has history of bleeding disorders or refuses blood transfusions.
• Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl
• Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.
• Patient has a body habitus that would inhibit X-ray visualization of the aorta.
• Patient has a limited life expectancy of less than 1 year.
• Patient is currently participating in an investigational device or drug clinical trial.
• 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.

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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