Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry (GELATIN)

Medical College of Wisconsin

Status and phase

Withdrawn

Phase 4

Conditions

Aneurysm

Intracranial Aneurysms

Brain Aneurysm

Treatments

Device: Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02037932

00021229

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is 18-80 years of age.
Patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization.
Target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less.
Patient has a Hunt and Hess Score of 3 or less.
Patient has a premorbid mRS of 3 or less.
Patient or patient's legally authorized representative has provided written informed consent.
Patient is willing to and can comply with study follow-up requirements.

Exclusion criteria

Inability to obtain informed consent.
Patient is <18 or >80 years of age.
Target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related.
Aneurysm that was treated previously with stent-assisted coiling.
Implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling.
Target aneurysm is deemed unsuitable for balloon-assisted coiling by the treating physician prior to the procedure.
Target aneurysm will be treated with a total coil length comprised of less than 80% second generation MicroVention Hydrogel Coils.
Balloon-assisted coiling will be performed using a balloon catheter other than the MicroVention Scepter balloon (Scepter C, Scepter XC, any future Scepter configurations).
Patients in which the target aneurysm is planned not to be coiled in one procedure (i.e. staged procedure).
Patients with more than one aneurysm that requires treatment. (However, a second small low risk aneurysm that does not require therapy may be allowed.)
Patients with a life expectancy of ≤ 9 months.