The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.
This is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using MicroVention second-generation hydrogel coils and undergo balloon remodeling with the MicroVention Scepter Occlusion Balloon Catheter. Data for each patient will be collected 6 ± 3 months post-procedure for the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aneurysm recurrence rate
Time frame: 3-9 month follow-up
Occlusion Rate
Angiographic occlusion of the aneurysm will be adjudicated using immediate post-procedure and 3-9 month follow-up angiography.
Time frame: At immediate post-procedure (Day 1) and 3-9 month follow-up
Number of coils used
Time frame: At end of study procedure (Day 1)
Total coil length used
Time frame: At immediate post-procedure (Day 1)
Aneurysm re-treatment rate
Time frame: 3-9 month follow-up
Aneurysm Bleed and Re-bleed Rate
Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
Time frame: 3-9 month follow-up
Time of fluoroscopic exposure
Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.
Time frame: At immediate post-procedure (Day 1)
Modified Rankin Score
Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.
Time frame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
Device-related serious adverse events
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Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.
Time frame: From the study procedure (Day 1) until 3-9 month follow up