NCT02037932

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

3.4 years

First QC Date

January 14, 2014

Last Update Submit

November 5, 2015

Conditions

Intracranial AneurysmsAneurysmBrain Aneurysm

Keywords

AneurysmBrain Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Aneurysm recurrence rate

    3-9 month follow-up

Secondary Outcomes (8)

  • Occlusion Rate

    At immediate post-procedure (Day 1) and 3-9 month follow-up

  • Number of coils used

    At end of study procedure (Day 1)

  • Total coil length used

    At immediate post-procedure (Day 1)

  • Aneurysm re-treatment rate

    3-9 month follow-up

  • Aneurysm Bleed and Re-bleed Rate

    3-9 month follow-up

  • +3 more secondary outcomes

Study Arms (1)

Balloon Assisted Coiling

EXPERIMENTAL

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

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.DEVICE

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

Also known as: MicroVention hydrogel coils, MicroVention Scepter C, MicroVention Scepter XC
Balloon Assisted Coiling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Intracranial AneurysmAneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Osama O Zaidat, MD, MS

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

US(1)