Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

Phase 4

Withdrawn

• Conditions: Intracranial Aneurysms; Brain Aneurysm; Aneurysm
• Interventions: Device: Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.

• Registration Number: NCT02037932
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balloon Assisted Coiling	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.

Primary Outcome Measures

Name	Time	Method
Aneurysm recurrence rate	3-9 month follow-up

Secondary Outcome Measures

Name	Time	Method
Number of coils used	At end of study procedure (Day 1)
Aneurysm re-treatment rate	3-9 month follow-up
Modified Rankin Score	At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up	Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.
Occlusion Rate	At immediate post-procedure (Day 1) and 3-9 month follow-up	Angiographic occlusion of the aneurysm will be adjudicated using immediate post-procedure and 3-9 month follow-up angiography.
Total coil length used	At immediate post-procedure (Day 1)
Device-related serious adverse events	From the study procedure (Day 1) until 3-9 month follow up	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.
Aneurysm Bleed and Re-bleed Rate	3-9 month follow-up	Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
Time of fluoroscopic exposure	At immediate post-procedure (Day 1)	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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States