Abdominal Aortic Aneurysm Clinical Trial
Official title:
A Phase II Evaluation of the Safety and Efficacy of the Boston Scientific ENOVUS AAA Endograft in the Treatment of Abdominal Aortic Aneurysms
A prospective, actively controlled, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft when used in the treatment of patients with AAA (Treatment Group) as compared to patients treated with conventional open surgery (Control Group).
The primary objectives of this study are to determine whether the Boston Scientific ENOVUS
AAA Endograft is a safe and effective method of treating AAA's in those patients considered
to be suitable candidates for open surgical repair. The safety of the Boston Scientific
ENOVUS AAA Endograft will be determined by comparing the rate of major morbidity in the
Treatment Group against the rate of major morbidity in the Control Group within 30 days of
the initial procedure. The efficacy of the Boston Scientific ENOVUS AAA Endograft will be
determined by evaluating the proportion of patients in the Treatment Group that are free
from AAA rupture and conversion to open surgical repair within 1 year of the initial
procedure.
The secondary safety endpoints will be compared between the Treatment and Control
Groups:Mortality rates at 30 days and 1 year, AAA related mortality at 30 days and 1 year.
The secondary efficacy endpoints will be evaluated in the Treatment Group only and include:
Technical success, enlargement of AAA, migration, significant endoleak, and loss of device
integrity. Secondary Clinical Utility endpoints will be compared between the Treatment and
Control groups and will include: blood loss, duration of procedure, ICU stay, length of
hospital stay, and duration of anesthesia.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT01843335 -
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
|
N/A | |
| 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
|
||
| 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
|