Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

Aneurysm Clinical Trial

— GELATIN  

Official title:

Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02037932
• Other study ID #: 00021229
• Status: Withdrawn
• Phase: Phase 4
• First received: January 14, 2014
• Last updated: November 5, 2015
• Start date: January 2014
• Est. completion date: June 2017

Study information

• Verified date: November 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Brain Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Microvention-Terumo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneurysm recurrence rate		3-9 month follow-up	No
Secondary	Occlusion Rate	Angiographic occlusion of the aneurysm will be adjudicated using immediate post-procedure and 3-9 month follow-up angiography.	At immediate post-procedure (Day 1) and 3-9 month follow-up	No
Secondary	Number of coils used		At end of study procedure (Day 1)	No
Secondary	Total coil length used		At immediate post-procedure (Day 1)	No
Secondary	Aneurysm re-treatment rate		3-9 month follow-up	No
Secondary	Aneurysm Bleed and Re-bleed Rate	Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.	3-9 month follow-up	Yes
Secondary	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.	At immediate post-procedure (Day 1)	Yes
Secondary	Modified Rankin Score	Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.	At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up	No
Secondary	Device-related serious adverse events	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.	From the study procedure (Day 1) until 3-9 month follow up	Yes