This research study is being done to test the effectiveness of a new generation FDA approved device for treating aneurysms compared to the current standard device for endovascular aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of minimally invasive surgery, which is performed on blood vessels. The technique involves the introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found near the groin. The catheter is then maneuvered through the body to the location of the aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter. This is repeated until enough coils fill the aneurysm, blocking the blood flow to the aneurysm. The body responds by forming blood clots around the coil(s), which helps block the flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study will compare the study device to the standard bare platinum coil to see which is better at preventing future rupturing or leaking. The study device is called the HydroCoil Embolization System and this study is a post-market clinical trial. About 600 subjects from multiple institutions will take part in this study.
Your part in this study will last up to 24 months and will involve 6 visits (1 baseline visit before your surgery, the surgical procedure and 4 follow-up visits). These visits will occur at the same time as the visits you would receive as standard of care after your surgery. If you are in this study, you will be placed in one of two study groups by chance using a process similar to the flip of a coin. This process is called randomization. Neither you nor the study staff will select the group you will be in. One group, the control group, will have their aneurysm treated by the bare platinum coils during their endovascular procedure. The other group, the study group will receive coils from the HydroCoil Embolization System. Both groups will receive the same standard of care and follow-up, but during the surgery different types of coils will be used.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
HydroCoil Embolic System
bare platinum coils
St. Joseph's Hospital
Phoenix, Arizona, United States
Mercy General Hospital
Sacramento, California, United States
Kaiser Permanente Sacramento
Sacramento, California, United States
Christiana Hospital
Newark, Delaware, United States
Lyerly Neurosurgery
Jacksonville, Florida, United States
Number of Patients With Aneurysm Recurrence Post Surgery
Defined as any progression on the Raymond-Roy (RR) Aneurysm Occlusion Scale. The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.
Time frame: post surgery to 24 months
Packing Density
Packing density as measured by volumetric filling of the aneurysm
Time frame: at operation
Clinical Outcome: Modified Rankin Scale (mRS)
modified rankin scale is a measure of neurological disability, which ranges from 0=no symptoms to 5=severe disability (6=dead).
Time frame: 24 months
Number of Participants With Adverse Events Related to the Procedure and/or the Device by Participant at Any Time in the Study.
number of participants who experienced any peri-procedural or post-procedural Adverse Event noted to be related to the procedure or device.
Time frame: 24 months
Total Number of Peri-procedural and Post-procedural Adverse Events Related to the Procedure and/or the Device.
total number of Adverse Events per person that were noted to be related to the procedure and device during the study
Time frame: 24 months
Number of Patients Who Expired During the Study (Mortality Rate)
all-cause mortality at any time during study follow-up
Time frame: 24 months
Number of Participants With Initial Complete Occlusion
Raymond-Roy (RR) Scale=1 at procedure The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.
Time frame: at procedure
Number of Patients Who Needed Re-treatment of Target Aneurysm
During the 24 month follow-up, if Aneurysm needed to be re-treated.
Time frame: 24 months
Number of Participants Experiencing a Hemorrhage From Target Aneurysm Post Surgery
Per the Adverse event log, if a hemorrhage or rupture occurred that was noted to be related to the procedure or device at any point during the 24 month follow-up (not during the operation).
Time frame: 24 months
Number of Participants Who Progressed on the Meyers Scale
Occlusion (in)stability was determined by progression on the Meyers scale. The Meyer scale is a 6-point grading scale based on the percentage of the aneurysm filled by contrast on DSA. Grade zero indicates complete and total aneurysm occlusion without remnant or in-terstitial filling within the aneurysm. Grade 1 represents greater than 90%volumetric occlusion of the aneurysm based on planar imaging assessment; grade 2, 70%-89% aneurysm occlusion; grade 3,50%-69%; grade 4, 25%-49%; and grade 5, less than 25% volumetric aneurysm occlusion.
Time frame: 24 months
Number of Participants Experiencing Major Versus Minor Recurrence by 24 Months Follow-up.
Major recurrence is defined as progression on the Raymond-Roy (RR) Scale to 3, or if initial RR was 3, then progression on the Meyers scale. Minor recurrence was defined as a progression on the RR scale to 2. The RR scale is a 3 point measure of occlusion, 1=total, 2=residual neck, and 3=residual aneurysm. The Meyer scale is a 6-point grading scale based on the percentageof the aneurysm filled by contrast on DSA. Grade zero indicates complete and total aneurysm occlusion without remnant or in-terstitial filling within the aneurysm. Grade 1 represents \>90%volumetric occlusion of the aneurysm based on planar imaging assessment; grade 2, 70%-89% aneurysm occlusion; grade 3,50%-69%; grade 4, 25%-49%; and grade 5, \<25% volumetric aneurysm occlusion.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic
Jacksonville, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Queens Medical Center
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Advocate Health
Oak Lawn, Illinois, United States
...and 34 more locations