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Direct Intra-arterial Thrombectomy in Order to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals (DIRECT-MT)

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ClinicalTrials.gov Identifier: NCT03469206
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
National Health and Family Planning Commission, P.R.China
Wu Jieping Medical Foundation
Cardiovascular Chinese Research Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Jian-min Liu, Changhai Hospital

Brief Summary:

Background: Intravenous thrombolysis (IVT) combined with mechanical thrombectomy (MT) has been proven safe and effective in patients with acute ischemic stroke (AIS) of anterior circulation large vessel occlusion (LVO). Despite recanalization, a considerable proportion of patients do not recover. The incidence of symptomatic intracerebral hemorrhage (sICH) was similar between bridging therapy and IVT, suggesting that this complication could not be attributed to the MT, but rather to pre-treatment with IVT. Meanwhile, the incidence of intracranial atherosclerosis stenosis (ICAS) is higher in Asians. It is not clear whether patients with ICAS benefit from pretreatment with alteplase or not and how ICAS modifies treatment effect.

Objective: The primary objective is to assess the effect of direct MT compared to bridging therapy in patients with AIS due to an anterior circulation LVO. Secondary objective is to assess treatment effect modification by presence of ICAS.

Study design: This is a parallel group, RCT of direct MT versus bridging therapy, using a non-inferiority design. The trial has observer blinded assessment of the primary outcome and of neuro-imaging at baseline and follow up. The trial will be executed in collaboration with MRCLEAN NO-IV investigators.

Study population: Patients with AIS of anterior circulation VLO confirmed by CTA. Initiation of IVT must be feasible within 4.5 hours from symptom onset. Age must be 18 or over and NIHSS 2 or more.

Main outcomes: The full distribution of the mRS at 3 months Secondary outcomes: eTICI score on postprocedural DSA, NIHSS at 24 hours and 5-7 days, recanalization on CTA at 24 hours and infarct size on CT at 5-7 days, dichotomous clinical outcome on the mRS and mortality at 90 days . Safety outcomes include rate of sICH.


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Cerebral Vascular Occlusion Thrombectomy Thrombolysis Procedure: intra-arterial thrombectomy Drug: Intravenous thrombolysis Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parallel Group, Randomized Clinical Trial of Direct Intra-arterial Thrombectomy Versus Intravenous Thrombolysis With Intra-arterial Thrombectomy for Patients With Large Vessel Occlusion of the Anterior Circulation
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Sham Comparator: Direct IAT
Direct intra-arterial thrombectomy (IAT) with no intravenous thrombolysis
Procedure: intra-arterial thrombectomy
It is the emergency surgical removal of emboli which are blocking blood circulation. It usually involves removal of thrombi (blood clots)

Sham Comparator: IVT combine with IAT
Intravenous thrombolysis before intra-arterial thrombectomy
Procedure: intra-arterial thrombectomy
It is the emergency surgical removal of emboli which are blocking blood circulation. It usually involves removal of thrombi (blood clots)

Drug: Intravenous thrombolysis
alteplase is used in the intravenous thrombolysis. It catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown.




Primary Outcome Measures :
  1. mRS (the modified Rankin Scale) [ Time Frame: 3 months after procedure ]
    The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability.


Secondary Outcome Measures :
  1. eTICI score (Extended Treatment In Cerebral Ischemia) [ Time Frame: Immediately after procedure ]
    The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores indicating better antegrade reperfusion of the previously occluded target artery ischemic territory.

  2. NIHSS (The National Institutes of Health Stroke Scale) [ Time Frame: at 24 hours and 5-7 days ]
    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.

  3. Recanalization rate [ Time Frame: at 24-48 hours after intra-arterial thrombectomy ]
    Recanalization rate at 24-48 hours after intra-arterial thrombectomy, assessed with CT angiography

  4. Final infarct volume [ Time Frame: at 5-7 days ]
    Final infarct volume will be assessed with the use of an automated, validated algorithm.

  5. sICH (symptomatic intracranial hemorrhage) rate [ Time Frame: 7 days after intra-arterial thrombectomy ]
    SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 7 days or any hemorrhage leading to death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a clinical diagnosis of acute ischemic stroke,
  • caused by a large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle M1/proximal M2) cerebral artery confirmed by CTA,
  • CT or MRI ruling out intracranial hemorrhage,
  • eligible for IVT and IAT (within 4.5 hours after symptom onset),
  • a score of at least 2 on the NIH Stroke Scale,
  • age of 18 years or older,
  • written informed consent.

Exclusion Criteria:

  • - Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
  • Any contra-indication for IVT, according to guidelines of the American Heart Association, i.e.:

    • arterial blood pressure exceeding 185/110 mmHg
    • blood glucose less than 2.7 or over 22.2 mmol/L
    • cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
    • serious head trauma in the previous 3 months
    • major surgery or serious trauma in the previous 2 weeks
    • gastrointestinal or urinary tract hemorrhage in the previous 3 weeks
    • previous intracerebral hemorrhage
    • use of anticoagulant with INR exceeding 1.7
    • known thrombocyte count less than 100 x 109/L
    • treatment with direct thrombin or factor X inhibitors
    • treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.

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): NCT03469206


Contacts
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Contact: Pengfei Yang, M.D. 86-21-31161784 15921196312@163.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Yanmin Liu, M.D.    86-21-31162338      
Sponsors and Collaborators
Changhai Hospital
National Health and Family Planning Commission, P.R.China
Wu Jieping Medical Foundation
Cardiovascular Chinese Research Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Jianmin Liu, M.D. Neurosurgery Department of Changhai Hospital
Principal Investigator: Benqiang Deng, M.D. Neurology Department of Changhai Hospital
Principal Investigator: Charles Majoie, M.D. Radiology Department of Academic Medical Center Amsterdam
Principal Investigator: Yvo Roos, M.D. Neurology Department of Academic Medical Center Amsterdam

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Responsible Party: Jian-min Liu, Dean of the department of Neurosurgery, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03469206     History of Changes
Other Study ID Numbers: DIRECT MT
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No