Trial document




drksid header

  DRKS00005792

Trial Description

start of 1:1-Block title

Title

Thrombectomy in patients ineligible for iv tPA

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

THRILL

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The primary objective of the THRILL study is to test efficacy and safety of thrombectomy (removal of a blood clot) with stent-retrievers in acute stroke patients as compared to best medical care alone. Patients are eligible for the study if a they have suffered the occlusion (blockage) of a large intracranial vessel up to 8 hours of symptom onset and are not eligible for a medical treatment with a lytic agent (IV-tPA).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This study is a prospective, open label, blinded endpoint (PROBE), binational (Germany and Austria), two-arm, randomized, controlled, postmarket study to compare the safety and effectiveness of stent-retrievers as a device class group as compared to best medical care alone in the treatment of acute ischemic stroke (AIS) in patients who are not eligible for IV-tPA up to 8 hours of symptom onset.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005792
  •   2014/05/06
  •   [---]*
  •   yes
  •   Approved
  •   S-579/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63 -  Cerebral infarction
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   best medical care
  •   endovascular thrombectomy using a stent-retriever and best medical care
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Degree of disability after stroke assessed by modified Rankin Scale (mRS) outcome at 90 days poststroke

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Good neurological outcome with 90-day mRS≤2 or 90-day NIHSS score improvement ≥10 from baseline
Excellent neurological outcomes with 90-day mRS≤1
Infarct volume at 30 (-/+ 6) hours (CT or MRI).
Difference of infarct volume from infarct volume as predicted by pretreatment imaging
Functional health status and quality of life 90 (±14) days after stroke (EQ-5D)
For the endovascular treatment group successful recanalization will be defined as TICI 2b or 3.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/04/20
  •   600
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Moderate to severe stroke (NIHSS>7 and <26)

Ineligibility for iv tPA and no prior iv tPA therapy

Premorbid mRS 0-1

Life expectancy > 6 Months

Treatment can be accomplished within 8 hours after stroke onset
Informed consent by the patient, legal guardian, or independent physician

Imaging criteria:
Occlusion of the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by MRA or CTA
CT and CBV map on CTP or DWI with an ASPECT score of 7-10

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patient is eligible for and receives IV tPA according to licensing criteria
Patient with an INR of >3
Patient is an active participant in another drug or device treatment trial for any disease state,
or patient is expected to start participation in another drug or device treatment trial while
enrolled in this protocol, unless approved by Sponsor.
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
Patient has history of contraindication for contrast medium.
Patient is known to have infective endocarditis
CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on
unenhanced CT and CBV drop on CBV maps on CTP, or, alternatively as per institutional
standard, restricted diffusion on DWI with an ASPECT score of 6 or less
Female of childbearing potential who is known to be pregnant and/or lactating or who has a
positive pregnancy test on admission.
Patients anticipated life expectancy is less than 6 Months.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • UniversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie
    • Mr.  Prof. Dr.  Martin  Bendszus 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • UniversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie
    • Mr.  Prof. Dr.  Martin  Bendszus 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • UniversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie
    • Mr.  Prof. Dr.  Martin  Bendszus 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Covidien LPNeurovascular business
    • 9775 Toledo Way
    • 92618  Irvine, CA
    • United States
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Stryker / Concentric Medical, Inc.USA
    • 301 East Evelyn Avenue
    • 94041  Mountain View, CA
    • United States
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   001877 471 0075
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2015/05/05
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.