Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)
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.
|Cerebral Aneurysm||Device: HydroCoil Embolic System Device: Control (bare platinum coils)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||New Generation Hydrogel Endovascular Aneurysm Treatment Trial|
- Aneurysm recurrence at any point during follow-up. [ Time Frame: 24 months ]Defined as any progression on the Raymond Aneurysm Occlusion Scale or the Meyers Aneurysm Occlusion Scale.
- Clinical outcome [ Time Frame: 24 months ]
Packing density as measured by volumetric filling of the aneurysm Clinical outcome at 18 - 24 months (mRS). Peri-procedural and post-procedural adverse events related to the procedure and/or the device.
Mortality rate,Initial Complete occlusion, Aneurysm re-treatment, hemorrhage from target aneurysm during follow-up, Aneurysm occlusion stability, Major versus minor recurrence.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
HydroCoil Embolic System
Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950)
Device: HydroCoil Embolic System
HydroCoil Embolic System
Other Name: MicroVention, Inc
Aneurysm treatment using bare platinum coil(s)
Device: Control (bare platinum coils)
bare platinum coils
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407952
Show 45 Study Locations
|Principal Investigator:||Bernard R Bendok, MD||Northwestern University|