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

NCT02479191 | Completed

• 1 other identifier: 771-0016
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal; Aortic; Aneurysm

Outcome Measures

Primary Outcomes (1)

• Major Adverse Event (MAE)

  1 month (30 ± 10 days)

Secondary Outcomes (11)

• 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)

Study Arms (2)

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

Interventions

Ovation Abdominal Stent Graft Platform DEVICE

Female (Treatment Group); Male (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

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

Sponsors & Collaborators

• TriVascular, Inc.: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 24, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: September 30, 2019
• Last Updated: June 1, 2021

Record last verified: 2021-05

Locations

US (1)