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

November 29, 2011
September 5, 2012
February 2012
January 2013   (final data collection date for primary outcome measure)
recanalization within 1 year after embolization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516658 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intracranial Aneurysm
  • Subarachnoid Hemorrhage
  • Device: Hydrogel coil
    at least one Hydrogel coil have to use for embolization
    Other Names:
    • Hydrocoil
    • HydroSoft
    • HydroFrame
  • Device: Bare platinum coil
    only bare platinum coil have to use for embolization
    Other Names:
    • detachable coil
    • GDC
    • Microvention
  • Experimental: Hydrogel coil group
    use Hydrogel Coil as much as be able to use
    Intervention: Device: Hydrogel coil
  • Active Comparator: Bare platinum coil group
    use only bare platinum coil
    Intervention: Device: Bare platinum coil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
January 2014
January 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01516658
TRIBRAIN1119, UMIN000006748
Yes
Nobuyuki Sakai, Kobe City General Hospital
Kobe City General Hospital
Translational Research Informatics Center, Kobe, Hyogo, Japan
Principal Investigator: Nobuyuki Sakai, MD, DMSc Kobe City Medical Center General Hospital
Kobe City General Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP