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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Translational Research Informatics Center, Kobe, Hyogo, Japan
Information provided by (Responsible Party):
Nobuyuki Sakai, Kobe City General Hospital
ClinicalTrials.gov Identifier:
NCT01516658
First received: November 29, 2011
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Intracranial Aneurysm
Subarachnoid Hemorrhage
 Device: Hydrogel coil
Device: Bare platinum coil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kobe City General Hospital:

Primary Outcome Measures:
  • recanalization within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • aneurysmal rupture within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • any event within 30 days after embolization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • aneurysmal retreatment within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • aneurysmal rupture and any death within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • any stroke within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • change in aneurysmal occlusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • any complicaion within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: February 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Informatics Center, Kobe, Hyogo, Japan
Investigators
Principal Investigator: Nobuyuki Sakai, MD, DMSc Kobe City Medical Center General Hospital
  More Information

No publications provided

Responsible Party: Nobuyuki Sakai, Director of Neurosurgery, Kobe City General Hospital
ClinicalTrials.gov Identifier: NCT01516658     History of Changes
Other Study ID Numbers: TRIBRAIN1119, UMIN000006748
Study First Received: November 29, 2011
Last Updated: September 5, 2012
Health Authority: Japan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013