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Trial record 2 of 2 for:    TriVascular Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair

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

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ClinicalTrials.gov Identifier: NCT02479191
Recruitment Status : Unknown
Verified April 2017 by TriVascular, Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Device: Ovation Abdominal Stent Graft Platform

Detailed Description:

The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the Ovation Abdominal Stent Graft Platform when used in the endovascular treatment of female patients.

The primary endpoint is the Major Adverse Event (MAE) rate within 30 days of the initial procedure. MAEs will be adjudicated and reported based upon an independent Clinical Events Committee (CEC).

Secondary endpoints of the study will be achieved by demonstrating the benefits in female patients (Treatment Group) are comparable to male patients (Control Group) 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.

A maximum of 45 sites across the United States are expected to enroll 225 subjects (75 females in the Treatment Group and 150 males in the Control Group).


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Study Type : Observational [Patient Registry]
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair
Study Start Date : August 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Major Adverse Event (MAE) [ Time Frame: 1 month (30 ± 10 days) ]

Secondary Outcome Measures :
  1. Serious and Non-Serious Adverse Events [ Time Frame: 1 year (365 ± 60 days) ]
  2. Access-related vascular complications [ Time Frame: 1 year (365 ± 60 days) ]
  3. Technical (deployment) success [ Time Frame: 1 year (365 ± 60 days) ]
  4. Freedom from Type I & III endoleaks [ Time Frame: 1 year (365 ± 60 days) ]
  5. Freedom from migration [ Time Frame: 1 year (365 ± 60 days) ]
  6. Freedom from aneurysm enlargement [ Time Frame: 1 year (365 ± 60 days) ]
  7. Freedom from AAA rupture [ Time Frame: 1 year (365 ± 60 days) ]
  8. Freedom from conversion to open repair [ Time Frame: 1 year (365 ± 60 days) ]
  9. Freedom from AAA related secondary interventions [ Time Frame: 1 year (365 ± 60 days) ]
  10. Freedom from mortality (all cause and AAA related) [ Time Frame: 1 year (365 ± 60 days) ]
  11. Clinical Utility, including: [ Time Frame: 1 year (365 ± 60 days) ]
    Blood loss, including if transfusion required, Duration of procedure, Length of hospital and ICU (if required) stay, Anesthesia type



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Patient is > 18 years of age.
  2. 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).
  3. Patient has signed an Institutional Review Board (IRB) 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; refer to Appendix II: ASA Classification System). 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:

    1. Abdominal aortic aneurysm >5.0 cm in diameter;
    2. Aneurysm has increased in size by 0.5 cm in last 6 months; or
    3. 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:

    1. Iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Platform.
    2. 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.
    3. Distal iliac artery landing zone length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
    4. Distal iliac artery landing zone an inner wall diameter of no less than 8 mm and no greater than 25 mm.
    5. Distance from the most distal renal artery to most superior internal iliac artery measurement is at least 130 mm.
    6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479191


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
TriVascular, Inc.
Investigators
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Study Chair: 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

Additional Information:
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Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT02479191     History of Changes
Other Study ID Numbers: 771-0016
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017

Keywords provided by TriVascular, Inc.:
Abdominal
Aortic
Aneurysm

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases