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

Abdominal Aortic Aneurysm Clinical Trial

— LUCY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703428
• Other study ID #: 771-0019
• Status: Completed
• Start date: February 2016
• Est. completion date: May 2019

Study information

• Verified date: June 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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). 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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Belgium	OLV Ziekhenuis	Aalst
Belgium	UZ Leuven	Leuven
Germany	HGZ Bad Bevensen	Bad Bevensen
Germany	August Krankenhaus	Dusseldorf
Germany	University of Düsseldorf	Düsseldorf
Germany	University Medical Center Hamburg	Hamburg
Germany	Hospital Karlsruhe	Karlsruhe
Germany	University of Leipzig	Leipzig
Poland	Institute of Hematology and Blood Transfusion	Warsaw
United Kingdom	Bedfordshire Hospitals NHS Trust	Bedford

Sponsors (2)

Lead Sponsor	Collaborator
TriVascular, Inc.	Endologix

Countries where clinical trial is conducted

Belgium,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.		30 ± 10 days
Secondary	Serious and Non-Serious Adverse Events		365 ± 60 days
Secondary	Access-related vascular complications		365 ± 60 days
Secondary	Technical (deployment) success	Defined as successful delivery and deployment of one aortic body and at least two iliac limbs.	365 ± 60 days
Secondary	Freedom from Type I & III endoleaks		365 ± 60 days
Secondary	Freedom from migration		365 ± 60 days
Secondary	Freedom from aneurysm enlargement		365 ± 60 days
Secondary	Freedom from Abdominal Aortic Aneurysm rupture		365 ± 60 days
Secondary	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.	365 ± 60 days
Secondary	Freedom from AAA related secondary interventions		365 ± 60 days
Secondary	Freedom from mortality (all cause and AAA related)		365 ± 60 days
Secondary	Blood Loss	Estimate blood loss and replacement requirements, (e.g. transfusion).	365 ± 60 days
Secondary	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.	365 ± 60 days
Secondary	Length of hospital and ICU (if required)		365 ± 60 days
Secondary	Anesthesia Type		365 ± 60 days

External Links

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