Abdominal Aortic AneurysmLUCYNCT02479191

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

An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aortic Aneurysm
What is being tested?: Ovation Abdominal Stent Graft Platform
Type of treatment: Medical device
How many people: 225 participants
Where: 1 siteUnited States
Study dates: Aug 2015to 30 Sep 2019
How long will I take part?: 1 Year
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
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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;

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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

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

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

Read the 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).

Conditions: Abdominal Aortic Aneurysm
Being tested: Ovation Abdominal Stent Graft Platform
Keywords: Abdominal, Aortic, Aneurysm
Medical subject headings: Aortic Aneurysm, Abdominal, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ovation Abdominal Stent Graft PlatformDevice

Study groups in NCT02479191
Study group	Role	What they receive
Female (Treatment Group)		Device: Ovation Abdominal Stent Graft Platform Receives: Device: Ovation Abdominal Stent Graft Platform
Male (Control Group)		Device: Ovation Abdominal Stent Graft Platform Receives: Device: Ovation Abdominal Stent Graft Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Event (MAE)
Measured: 1 month (30 ± 10 days)

Secondary outcomes (11)

Serious and Non-Serious Adverse Events
Measured: 1 year (365 ± 60 days)
Access-related vascular complications
Measured: 1 year (365 ± 60 days)
Technical (deployment) success
Measured: 1 year (365 ± 60 days)
Freedom from Type I & III endoleaks
Measured: 1 year (365 ± 60 days)
Freedom from migration
Measured: 1 year (365 ± 60 days)
Freedom from aneurysm enlargement
Measured: 1 year (365 ± 60 days)
Freedom from AAA rupture
Measured: 1 year (365 ± 60 days)
Freedom from conversion to open repair
Measured: 1 year (365 ± 60 days)
Freedom from AAA related secondary interventions
Measured: 1 year (365 ± 60 days)
Freedom from mortality (all cause and AAA related)
Measured: 1 year (365 ± 60 days)
Clinical Utility, including:
Blood loss, including if transfusion required, Duration of procedure, Length of hospital and ICU (if required) stay, Anesthesia type
Measured: 1 year (365 ± 60 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201530 Sep 2019

First posted24 Jun 2015 (estimated)
Study startAug 2015
Primary completionMay 2019
Study completion30 Sep 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: 225 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT02479191
Sponsor's protocol ID: 771-0016
Acronym: LUCY
Status last verified: May 2021
First submitted: 18 Jun 2015
Last updated: 1 Jun 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
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Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
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Enrolling by invitation
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All Abdominal Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 1 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
ClinicalTrials.gov ID: NCT02479191
Acronym / sponsor ID: LUCY / 771-0016
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal, Aortic, Aneurysm
Study type: Observational
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: TriVascular, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2015 (actual)
Primary completion: May 2019 (actual)
Study completion: 30 Sep 2019 (actual)
First posted: 24 Jun 2015 (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.

Detailed description

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).

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).

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 2

Arm	Type	Receives
Female (Treatment Group)	–	Device: Ovation Abdominal Stent Graft PlatformDevice: Ovation Abdominal Stent Graft Platform
Male (Control Group)	–	Device: Ovation Abdominal Stent Graft PlatformDevice: Ovation Abdominal Stent Graft Platform

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (16 listed)

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:

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.

Interventions

Intervention	Type	Arms
Ovation Abdominal Stent Graft Platform	Device	Female (Treatment Group), Male (Control Group)

Primary outcome

Major Adverse Event (MAE)
Time frame: 1 month (30 ± 10 days)

11 secondary outcomes

Serious and Non-Serious Adverse Events
Time frame: 1 year (365 ± 60 days)
Access-related vascular complications
Time frame: 1 year (365 ± 60 days)
Technical (deployment) success
Time frame: 1 year (365 ± 60 days)
Freedom from Type I & III endoleaks
Time frame: 1 year (365 ± 60 days)
Freedom from migration
Time frame: 1 year (365 ± 60 days)
Freedom from aneurysm enlargement
Time frame: 1 year (365 ± 60 days)
Freedom from AAA rupture
Time frame: 1 year (365 ± 60 days)
Freedom from conversion to open repair
Time frame: 1 year (365 ± 60 days)
Freedom from AAA related secondary interventions
Time frame: 1 year (365 ± 60 days)
Freedom from mortality (all cause and AAA related)
Time frame: 1 year (365 ± 60 days)
Clinical Utility, including:
Time frame: 1 year (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 1 Jun 2021.

Related trials for Abdominal Aortic Aneurysm

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

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.

Jennifer Ash, MD study chair

Christie Clinic Vein & Vascular Center

Venita Chandra, MD study chair

Stanford School of Medicine

Eva Rzucidlo, MD study chair

Geisel School of Medicine, Dartmouth

1 site in 1 country: 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 1 site in United States.

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 1 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 1 site in United States. 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?

Major Adverse Event (MAE) (time frame: 1 month (30 ± 10 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02479191.

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 1 Jun 2021.