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Completed

NCT Number: NCT01516658

HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Arterial Diseases Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nakamura Memorial Hospital, Sapporo, Hokkaido, Japan

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About this study

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:

  • aneurysmal rupture within 1 year after embolization
  • any event within 30 days after embolization
  • recanalization within 6 months after embolization
  • aneurysmal retreatment within 1 year after embolization
  • aneurysmal rupture and any death within 1 year after embolization
  • any stroke within 1 year after embolization
  • any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
  • change in aneurysmal occlusion
  • any comlicaion within 1 year after embolization
  • %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrogel coil

Device

at least one Hydrogel coil have to use for embolization

Other names: Hydrocoil, HydroSoft, HydroFrame

Bare platinum coil

Device

only bare platinum coil have to use for embolization

Other names: detachable coil, GDC, Microvention

Primary outcomes

  1. recanalization within 1 year after embolization

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kobe City General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HYBRID

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jan 25, 2012
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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