NCT02347358

Brief Summary

This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA alone.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 10, 2015

Last Update Submit

January 26, 2015

Conditions

Ischemic Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

  • Early successful recanalisation (assessed by the imaging core laboratory)

    TIMI（thrombolysis in myocardial infarction）2 or 3 recanalisation 1 hour after enrollment blindly assessed by the imaging core laboratory and without any presence of symptomatic intracranial hemorrhage within 24 hours blindly assessed by independent neurologists.

    24 hours

Secondary Outcomes (3)

  • Good neurological outcome( modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale（NIHSS）score improvement of 10 points or more)

    90 days

  • Incidence of device related and procedure-related serious adverse events(SAEs)

    30 days

  • Additional safety end-points (symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days)

    90 days

Study Arms (2)

IV r-tPA with JRecanTM blood FR device

EXPERIMENTAL

Dual IV r-tPA therapy and adjunctive treatment with JRecanTM blood flow recanalisation device

Device: JRecanTM blood FR device

IV r-tPA

ACTIVE COMPARATOR

IV infusion of r-tPA

Drug: IV r-tPA

Interventions

JRecanTM blood FR deviceDEVICE

JRecanTM blood flow recanalisation device

IV r-tPA with JRecanTM blood FR device
IV r-tPADRUG

intravenous recombinant human tissue plasminogen activator

Also known as: intravenous recombinant human tissue plasminogen activator
IV r-tPA

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 75
  • Clinical presentations consistent with acute ischemic stroke
  • NIHSS ≥ 8 and \< 30 at the time of randomization
  • Initiation of the correct IV t-PA dose treatment within 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline)
  • Complement of catheter angiography within 6.5 hours of onset of stroke symptoms
  • Thrombolysis in myocardial Infarction (TIMI) 0-1 flow in the intracranial internal carotid artery, M1 segment of the MCA, basilar artery, or intracranial vertebral artery with contralaterally chronic intracranial vertebral artery occlusion confirmed by catheter angiography
  • The acute occlusion lesion is accessible to the JRecanTM blood flow recanalisation device
  • Functional independence before this time stroke (Modified Rankin Score ≤ 1)
  • Subject or subject's legally authorized representative has signed and dated an Informed Consent Form according to country regulations, ethics committee requirements.
  • Subject is willing to conduct protocol-required follow-up visits.

You may not qualify if:

  • NIHSS \<8 or ≥30
  • Rapid neurological improvement prior to study randomization
  • Female who is pregnant or lactating or has a positive pregnancy test at time of admission
  • Taking part in another clinical study.
  • History of stroke in the past 3 months.
  • Current participation in another investigational drug or device treatment study.
  • Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication.
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (Patients without history or suspicion of coagulopathy do not require INR or prothrombin time lab results to be available prior to enrollment.)
  • Warfarin therapy with INR greater than 1.7.
  • Low molecular Weight Heparins (such as Dalteparin, Enoxaparin, Tinzaparin, Fondaparinux) as DVT prophylaxis or in full dose within the last 24 hours from screening.
  • Subject who has received heparin or a direct thrombin inhibitor (e.g. rivaroxaban, Angiomax™, argatroban, Refludan™) within the last 48 hours must have a normal partial thromboplastin time (PTT) to be eligible.
  • Subject who has received factor Xa inhibitor therapy (e.g. dabigatran) within the past 24 hours must have a normal ecarin clotting time to be eligible. Subject who has received factor Xa inhibitor therapy more than 24 hours ago but less than 48 hours ago must have a normal partial thromboplastin time (PTT) to be eligible.
  • Baseline lab values: glucose \< 50 mg/dl or \> 400 mg/dl, platelets \< 100,000, or Hct \< 25.
  • Renal Failure as defined by a serum creatinine \> 2.0 or Glomerular Filtration Rate \[GFR\] \< 30.
  • Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Weijian Jiang, MD,PhD

    New Era Stroke Care and Research Institute, The Second Artillery General Hospital Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijian Jiang, MD,PhD

CONTACT

+8613901122837cjr.jiangweijian@vip.163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2015

First Posted

January 27, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

January 27, 2015

Record last verified: 2015-01