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Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry (GELATIN)

Primary Purpose

Intracranial Aneurysms, Aneurysm, Brain Aneurysm

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Intracranial Aneurysms focused on measuring Aneurysm, Brain Aneurysm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Balloon Assisted Coiling

Arm Description

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

Outcomes

Primary Outcome Measures

Aneurysm recurrence rate

Secondary Outcome Measures

Occlusion Rate

Angiographic occlusion of the aneurysm will be adjudicated using immediate post-procedure and 3-9 month follow-up angiography.

Number of coils used

Total coil length used

Aneurysm re-treatment rate

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 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.

Modified Rankin Score

Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.

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.

Full Information

NCT ID

NCT02037932

First Posted

January 14, 2014

Last Updated

November 5, 2015

Sponsor

Medical College of Wisconsin

Collaborators

Microvention-Terumo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02037932

Brief Title

Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

Acronym

GELATIN

Official Title

Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Investigator left institution

Study Start Date

January 2014 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical College of Wisconsin

Collaborators

Microvention-Terumo, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysms, Aneurysm, Brain Aneurysm

Keywords

Aneurysm, Brain Aneurysm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Balloon Assisted Coiling

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

MicroVention hydrogel coils, MicroVention Scepter C, MicroVention Scepter XC

Intervention Description

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

Primary Outcome Measure Information:

Title

Aneurysm recurrence rate

Time Frame

3-9 month follow-up

Secondary Outcome Measure Information:

Title

Occlusion Rate

Description

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

Title

Number of coils used

Time Frame

At end of study procedure (Day 1)

Title

Total coil length used

Time Frame

At immediate post-procedure (Day 1)

Title

Aneurysm re-treatment rate

Time Frame

3-9 month follow-up

Title

Aneurysm Bleed and Re-bleed Rate

Description

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

Title

Time of fluoroscopic exposure

Description

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)

Title

Modified Rankin Score

Description

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

Title

Device-related serious adverse events

Description

Time Frame

From the study procedure (Day 1) until 3-9 month follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama O Zaidat, MD, MS

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

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Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

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