HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study (HYBRID)

October 14, 2019 updated by: Nobuyuki Sakai, Kobe City General Hospital

Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial

HYBRID study is prospective randomized open label controlled multi center trial, to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At least one Hydrocoil have to use in Hydrocoil arm, and only bare platinum coil have to use in Control arm.

Primary endpoint is recanalization within 1 year after embolization, and secondary endpoint are:

  1. aneurysmal rupture within 1 year after embolization
  2. any event within 30 days after embolization
  3. recanalization within 6 months after embolization
  4. aneurysmal retreatment within 1 year after embolization
  5. aneurysmal rupture and any death within 1 year after embolization
  6. any stroke within 1 year after embolization
  7. any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
  8. change in aneurysmal occlusion
  9. any comlicaion within 1 year after embolization
  10. %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Not Applicable

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

  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Nakamura Memorial Hospital
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City General Hospital

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

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • saccular intracranial aneurysm
  • endovascular treatment scheduled within 60days after consent
  • 20-79 years old
  • unruptured, chronic SAH or acurte SAH Grade 1-III
  • 7-20mm in size
  • 1 year follow up possibel
  • independent (mRS 0-2)
  • document consent

Exclusion Criteria:

  • previous endovascular treated
  • additional aneurysm scheduled of endovascular treatment
  • pregnant
  • ineligible for study

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydrogel coil group
use Hydrogel Coil as much as be able to use
Device: Hydrogel coil
at least one Hydrogel coil have to use for embolization
Other Names:
  • HydroFrame
  • HydroSoft
  • Hydrocoil
ACTIVE_COMPARATOR: Bare platinum coil group
use only bare platinum coil
Device: Bare platinum coil
only bare platinum coil have to use for embolization
Other Names:
  • detachable coil
  • GDC
  • Microvention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recanalization within 1 year after embolization
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
aneurysmal rupture within 1 year after embolization
Time Frame: 1 year
1 year
any event within 30 days after embolization
Time Frame: 30 days
30 days
aneurysmal retreatment within 1 year after embolization
Time Frame: 1 year
1 year
aneurysmal rupture and any death within 1 year after embolization
Time Frame: 1 year
1 year
any stroke within 1 year after embolization
Time Frame: 1 year
1 year
any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
Time Frame: 1 year
1 year
change in aneurysmal occlusion
Time Frame: 1 year
1 year
any complicaion within 1 year after embolization
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Kobe City General Hospital

Collaborators

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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 (ACTUAL)

June 1, 2012

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

January 24, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIBRAIN1119
  • UMIN000006748 (OTHER: UMIN Japan)

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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