Abdominal Aortic Aneurysm Clinical Trial
Official title:
The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair
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.
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04227054 -
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
|
N/A | |
| Active, not recruiting |
NCT03687489 -
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
|
N/A | |
| Active, not recruiting |
NCT03507413 -
Metformin Therapy in Non-diabetic AAA Patients
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05756283 -
The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair
|
N/A | |
| Not yet recruiting |
NCT04089241 -
Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair
|
N/A | |
| Active, not recruiting |
NCT02604303 -
A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
|
||
| Terminated |
NCT02469376 -
Evaluation of a New Imagingtechnologie for Thrombosis
|
Phase 1 | |
| Completed |
NCT02229006 -
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
|
N/A | |
| Completed |
NCT02224794 -
LIFE Study: Least Invasive Fast-Track EVAR
|
||
| Terminated |
NCT01843335 -
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
|
N/A | |
| Completed |
NCT01118520 -
AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)
|
Phase 2 | |
| Terminated |
NCT01425242 -
Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension
|
N/A | |
| Completed |
NCT00746122 -
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
|
N/A | |
| Completed |
NCT03952780 -
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
|
||
| Completed |
NCT00583414 -
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
|
N/A | |
| Recruiting |
NCT05864560 -
Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
|
||
| Completed |
NCT01683084 -
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
|
Phase 4 | |
| Active, not recruiting |
NCT03180996 -
Global Fenestrated Anaconda Clinical sTudy
|
||
| Completed |
NCT02493296 -
The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
|
||
| Completed |
NCT03320408 -
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
|