Abdominal Aortic AneurysmLUCYNCT02703428
TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 30 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Feb 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany6 sites
HGZ Bad Bevensen
Bad Bevensen
August Krankenhaus
Düsseldorf, 40472
University of Düsseldorf
Düsseldorf
University Medical Center Hamburg
Hamburg
Hospital Karlsruhe
Karlsruhe
University of Leipzig
Leipzig
About this study
Official title: The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal, Aortic, Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.
Measured: 30 ± 10 days
Secondary outcomes (14)
Serious and Non-Serious Adverse Events
Measured: 365 ± 60 days
Access-related vascular complications
Measured: 365 ± 60 days
Technical (deployment) success
Defined as successful delivery and deployment of one aortic body and at least two iliac limbs.
Measured: 365 ± 60 days
Freedom from Type I & III endoleaks
Measured: 365 ± 60 days
Freedom from migration
Measured: 365 ± 60 days
Freedom from aneurysm enlargement
Measured: 365 ± 60 days
Freedom from Abdominal Aortic Aneurysm rupture
Measured: 365 ± 60 days
Freedom from conversion to open repair
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.
Measured: 365 ± 60 days
Freedom from AAA related secondary interventions
Measured: 365 ± 60 days
Freedom from mortality (all cause and AAA related)
Measured: 365 ± 60 days
Blood Loss
Estimate blood loss and replacement requirements, (e.g. transfusion).
Measured: 365 ± 60 days
Duration of Procedure
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.
Measured: 365 ± 60 days
Length of hospital and ICU (if required)
Measured: 365 ± 60 days
Anesthesia Type
Measured: 365 ± 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriVascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Endologix
- Responsible party
- Sponsor
- Investigators
- Ralf Kolvenbach, M.D., Ph.D., Principal investigator, Augusta Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703428
- Sponsor's protocol ID
- 771-0019
- Acronym
- LUCY
- Status last verified
- Jun 2021
- First submitted
- 25 Feb 2016
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
- ClinicalTrials.gov ID
- NCT02703428
- Acronym / sponsor ID
- LUCY / 771-0019
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal, Aortic, Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TriVascular, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Endologix
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.
Time frame: 30 ± 10 days
14 secondary outcomes
Serious and Non-Serious Adverse Events
Time frame: 365 ± 60 days
Access-related vascular complications
Time frame: 365 ± 60 days
Technical (deployment) success
Time frame: 365 ± 60 days
Freedom from Type I & III endoleaks
Time frame: 365 ± 60 days
Freedom from migration
Time frame: 365 ± 60 days
Freedom from aneurysm enlargement
Time frame: 365 ± 60 days
Freedom from Abdominal Aortic Aneurysm rupture
Time frame: 365 ± 60 days
Freedom from conversion to open repair
Time frame: 365 ± 60 days
Freedom from AAA related secondary interventions
Time frame: 365 ± 60 days
Freedom from mortality (all cause and AAA related)
Time frame: 365 ± 60 days
Blood Loss
Time frame: 365 ± 60 days
Duration of Procedure
Time frame: 365 ± 60 days
Length of hospital and ICU (if required)
Time frame: 365 ± 60 days
Anesthesia Type
Time frame: 365 ± 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Kolvenbach, M.D., Ph.D. principal investigator
Augusta Krankenhaus
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Belgium, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days. (time frame: 30 ± 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.