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

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ClinicalTrials.gov Identifier: NCT01516658
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Information provided by (Responsible Party):
Nobuyuki Sakai, Kobe City General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Subarachnoid Hemorrhage Device: Hydrogel coil Device: Bare platinum coil Phase 4

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  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
Actual Study Start Date : June 2012
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:
  • Hydrocoil
  • HydroSoft
  • HydroFrame
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



Primary Outcome Measures :
  1. recanalization within 1 year after embolization [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. aneurysmal rupture within 1 year after embolization [ Time Frame: 1 year ]
  2. any event within 30 days after embolization [ Time Frame: 30 days ]
  3. aneurysmal retreatment within 1 year after embolization [ Time Frame: 1 year ]
  4. aneurysmal rupture and any death within 1 year after embolization [ Time Frame: 1 year ]
  5. any stroke within 1 year after embolization [ Time Frame: 1 year ]
  6. any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization [ Time Frame: 1 year ]
  7. change in aneurysmal occlusion [ Time Frame: 1 year ]
  8. any complicaion within 1 year after embolization [ Time Frame: 1 year ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516658


Locations
Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
Kobe City General Hospital
Kobe, Hyogo, Japan
Sponsors and Collaborators
Kobe City General Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Investigators
Principal Investigator: Nobuyuki Sakai, MD, DMSc Kobe City Medical Center General Hospital

Responsible Party: Nobuyuki Sakai, Director of Neurosurgery, Kobe City General Hospital
ClinicalTrials.gov Identifier: NCT01516658     History of Changes
Other Study ID Numbers: TRIBRAIN1119
UMIN000006748 ( Other Identifier: UMIN Japan )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Nobuyuki Sakai, Kobe City General Hospital:
intracranial aneurysm
endovascular therapy
detachable coil
recanalization

Additional relevant MeSH terms:
Hemorrhage
Aneurysm
Subarachnoid Hemorrhage
Intracranial Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases