Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry (GELATIN)

November 5, 2015 updated by: Medical College of Wisconsin
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balloon Assisted Coiling
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.
Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
Other Names:
  • MicroVention hydrogel coils
  • MicroVention Scepter C
  • MicroVention Scepter XC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aneurysm recurrence rate
Time Frame: 3-9 month follow-up
3-9 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneurysm Bleed and Re-bleed Rate
Time Frame: 3-9 month follow-up
Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
3-9 month follow-up
Modified Rankin Score
Time Frame: 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.
At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
Device-related serious adverse events
Time Frame: 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.
From the study procedure (Day 1) until 3-9 month follow up
Occlusion Rate
Time Frame: 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.
At immediate post-procedure (Day 1) and 3-9 month follow-up
Number of coils used
Time Frame: At end of study procedure (Day 1)
At end of study procedure (Day 1)
Total coil length used
Time Frame: At immediate post-procedure (Day 1)
At immediate post-procedure (Day 1)
Aneurysm re-treatment rate
Time Frame: 3-9 month follow-up
3-9 month follow-up
Time of fluoroscopic exposure
Time Frame: 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.
At immediate post-procedure (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: Osama O Zaidat, MD, MS, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00021229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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