The Lucy Study
Research type
Research Study
Full title
TriVascular Evaluation of Females who are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
IRAS ID
215559
Contact name
Luisa Colombo
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
The LUCY study was developed specifically to evaluate the clinical outcomes of the Ovation Device when used in the treatment of Abdominal Aortic Aneurysms (AAA) in female patients. Ovation is an endovascular device: this means that it can be placed in the patient's aorta without the need of an open surgery, but with a minimally invasive procedure, introducing the device through the patients vessels (typically the femoral arteries). This procedure is called EVAR (EndoVascular Aneurysm Repair).
The number of women in EVAR clinical trials is low and this results in a lack of information for these patients and their physicians regarding risks and benefits of endovascular therapies. The Ovation platform has a low profile, that means is small enough to pass through small-diameter access vessels so it is particularly well-suited for female patients, because women have usually smaller vessels compared to men.
The study will enroll 60 female subjects in up to 12 sites in Europe
Patients enrolled in the LUCY study will be treated with the Ovation device and will receive FU visit and CT scan at 1 month and 1 year after the initial procedure.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0100
Date of REC Opinion
22 May 2017
REC opinion
Further Information Favourable Opinion