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

NCT02703428 | Completed

• 1 other identifier: 771-0019
• Study Type: observational
• Target: 30
• Locations: 4 countries
• Sites: 10

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal; Aortic; Aneurysm

Outcome Measures

Primary Outcomes (1)

• Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.

  30 ± 10 days

Secondary Outcomes (14)

• Serious and Non-Serious Adverse Events

  365 ± 60 days

• Access-related vascular complications

  365 ± 60 days

• Technical (deployment) success

  365 ± 60 days

• Freedom from Type I & III endoleaks

  365 ± 60 days

• Freedom from migration

  365 ± 60 days

Eligibility Criteria

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

You may qualify if:

• Patient is \> 18 years of age.
• Patients who are non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study).
• Patient has signed an Ethics Committee (EC) 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). 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
• Endologix: collaborator

Study Sites (10)

OLV Ziekhenuis

Aalst, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

HGZ Bad Bevensen

Bad Bevensen, Germany

Location

August Krankenhaus

Düsseldorf, 40472, Germany

Location

University of Düsseldorf

Düsseldorf, Germany

Location

University Medical Center Hamburg

Hamburg, Germany

Location

Hospital Karlsruhe

Karlsruhe, Germany

Location

University of Leipzig

Leipzig, Germany

Location

Institute of Hematology and Blood Transfusion

Warsaw, Poland

Location

Bedfordshire Hospitals NHS Trust

Bedford, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Ralf Kolvenbach, M.D., Ph.D.

  Augusta Krankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 9, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

GB (1); BE (2); PL (1); DE (6)