New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial.

ABSTRACT

PURPOSE: Aneurysm recanalization constitutes a limitation in the endovascular treatment of intracranial aneurysms using conventional bare platinum coils. The development of platinum coils coupled with hydrogel polymers aimed at decreasing the rates of recurrence by way of enhanced coil packing density and biological healing within the aneurysm. While enhanced occlusion and durability has been shown for the first generation hydrogel coils, their use was limited by technical challenges. Less data is available regarding the second-generation hydrogel coils which have been designed to perform like bare platinum coils. METHODS: The new generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT) is a multicenter, randomized controlled trial that compares the health outcomes of the second-generation HydroCoil Embolic System with bare platinum coils in the endovascular intracranial aneurysms. The primary endpoint is aneurysm recurrence, defined as any progression on the Raymond aneurysm scale, over a 24-month follow-up period. Secondary endpoints include packing density, functional independence, procedural adverse events, mortality rate, initial complete occlusion, aneurysm retreatment, hemorrhage from treated aneurysm, and any aneurysm recurrence. RESULTS: Patient recruitment initiated in June 2011 and ended in January 2016 in 46 centers. Six hundred eligible patients diagnosed with an intracranial aneurysm, ruptured or unruptured were randomly assigned to one of the two treatment arms. CONCLUSION: The HEAT trial compares the durability, imaging, and clinical outcomes of the second-generation hydrogel versus bare platinum coils in the endovascular treatment of ruptured or unruptured intracranial aneurysms. The results of this trial may further inform current endovascular treatment guidelines based on observed long-term outcomes.