Abdominal Aortic Aneurysm Clinical Trial
Official title:
3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)
This is an Early Feasibility Study to evaluate the usability, safety and functionality of 3D holographic guidance, navigation, and control (3D-GNC) as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.
The goal of this clinical study is to evaluate the feasibility of using electromagnetic (EM) guidance and tracking to precisely place a Cook Zenith Flex AAA bifurcated stent graft during EVAR. EM guidance and tracking is enabled using a system consisting of the following: 1) experimental 3D guidance, navigation, and control (3D-GNC) software developed by Centerline Biomedical, Inc., integrated with the company's FDA-cleared Intra-Operative Positioning System (IOPS), 2) FDA-cleared compatible sensorized guidewires added to the Cook Zenith Flex delivery system and 3) 3D visualization on the IOPS mobile cart monitor and 3D holographic visualization overlaid on the patient during the procedure using a head mounted display (HMD), the Microsoft HoloLens 2. Planning and execution of each case will be major steps in demonstrating feasibility of the technology beyond non-clinical and preclinical testing. ;
| 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 | |
| Terminated |
NCT01843335 -
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
|
N/A | |
| Completed |
NCT02224794 -
LIFE Study: Least Invasive Fast-Track EVAR
|
||
| Completed |
NCT02229006 -
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
|
N/A | |
| Terminated |
NCT01425242 -
Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension
|
N/A | |
| Completed |
NCT01118520 -
AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)
|
Phase 2 | |
| 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
|