Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    TriVascular Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02703428
Recruitment Status : Active, not recruiting
First Posted : March 9, 2016
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Endologix
Information provided by (Responsible Party):
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.

Condition or disease
Abdominal Aortic Aneurysm

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
Study Start Date : July 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days. [ Time Frame: 30 ± 10 days ]

Secondary Outcome Measures :
  1. Serious and Non-Serious Adverse Events [ Time Frame: 365 ± 60 days ]
  2. Access-related vascular complications [ Time Frame: 365 ± 60 days ]
  3. Technical (deployment) success [ Time Frame: 365 ± 60 days ]
    Defined as successful delivery and deployment of one aortic body and at least two iliac limbs.

  4. Freedom from Type I & III endoleaks [ Time Frame: 365 ± 60 days ]
  5. Freedom from migration [ Time Frame: 365 ± 60 days ]
  6. Freedom from aneurysm enlargement [ Time Frame: 365 ± 60 days ]
  7. Freedom from Abdominal Aortic Aneurysm rupture [ Time Frame: 365 ± 60 days ]
  8. Freedom from conversion to open repair [ Time Frame: 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.

  9. Freedom from AAA related secondary interventions [ Time Frame: 365 ± 60 days ]
  10. Freedom from mortality (all cause and AAA related) [ Time Frame: 365 ± 60 days ]
  11. Blood Loss [ Time Frame: 365 ± 60 days ]
    Estimate blood loss and replacement requirements, (e.g. transfusion).

  12. Duration of Procedure [ Time Frame: 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.

  13. Length of hospital and ICU (if required) [ Time Frame: 365 ± 60 days ]
  14. Anesthesia Type [ Time Frame: 365 ± 60 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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; 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:

    • 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.

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): NCT02703428


Locations
Layout table for location information
Germany
Schwarzwald-Baar Klinik
Villigen-Schwennigen, Baden Wurttemberg, Germany, 78052
August Krankenhaus
Dusseldorf, Germany, 40472
Sponsors and Collaborators
TriVascular, Inc.
Endologix
Investigators
Layout table for investigator information
Principal Investigator: Ralf Kolvenbach, M.D., Ph.D. Augusta Krankenhaus

Additional Information:
Layout table for additonal information
Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT02703428     History of Changes
Other Study ID Numbers: 771-0019
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by TriVascular, Inc.:
Abdominal
Aortic
Aneurysm
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases