Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

NCT ID: NCT02037932

Last Updated: 2015-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-06-30

Brief Summary

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.

Detailed 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.

Conditions

Intracranial Aneurysms; Aneurysm; Brain Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Balloon Assisted Coiling

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Other Intervention Names

MicroVention hydrogel coils; MicroVention Scepter C; MicroVention Scepter XC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Microvention-Terumo, Inc.

INDUSTRY

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osama O Zaidat, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

00021229

Identifier Type: -

Identifier Source: org_study_id