UMIN-CTR Clinical Trial

Public title

Reperfuse Ischemic Vessels with Endovascular Recanalization Device in JAPAN (RIVER JAPAN)

Acronym

Reperfuse Ischemic Vessels with Endovascular Recanalization Device in JAPAN (RIVER JAPAN)

Scientific Title

Reperfuse Ischemic Vessels with Endovascular Recanalization Device in JAPAN (RIVER JAPAN)

Scientific Title:Acronym

Reperfuse Ischemic Vessels with Endovascular Recanalization Device in JAPAN (RIVER JAPAN)

Region

Japan

Condition

Acute Ischemic Stroke

Classification by specialty

Neurosurgery

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The main objective of this study is to document that the thrombectomy catheter (Rev-01) is effective and safe when used for revascularization in subjects with acute ischemic stroke within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom treatment with IV t-PA has been ineffective.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Proportion of patients who have recanalization immediately post procedure

Key secondary outcomes

Following neurological outcomes at 90 days post-procedure
- mRS score
- NIHSS score
- BI score

Proportion of patients with ICH (symptomatic and asymptomatic) at 24 hours post-procedure

All cause mortality at 90 days post-procedure

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intervention Device: Rev-01

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

- Onset of symptom is <= 8 hours prior to treatment with Rev-01
- Treatment with IV t-PA is ineligible or ineffective
- Occluded (presenting TICI score of 0 or 1) M1 or M2 of MCA, basilar or vertebral artery, or intracranial segment of ICA, confirmed by angiography that it is accessible to the Rev-01
- NIHSS score is 8-30
- Prior to new focal disabling neurologic deficit, mRS score was 0-2

Key exclusion criteria

- Acute intracranial hemorrhage
- Mass effect or intracranial tumor
- Extended early ischemic changes evidenced by CT or MRI
- Administration of heparin within 48 hours preceding the onset of stroke and have an elevated APTT or PTT above twice of the normal range for the laboratory at presentation
- Known bleeding diathesis of current use of oral anticoagulants (e.g., warfarin sodium) with International Normalized Ration (INR) > 3
- Platelet count < 30,000/mm3
- Glucose < 50 mg/dL
- Severe sustained hypertension (SBP > 185mmHG or DBP > 110mmHG) refractory to pharmacological management
- Life expectancy of less than 90 days
- Pregnancy or females who are lactating
- Current participation in an investigational drug or device study

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Sakai

Organization

Kobe City Medical Center General Hospital

Division name

Neurosurgery

Zip code

Address

2-1-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo

TEL

078-304-5200

Email

n.sakai@siren.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Kumiko Yagi

Organization

Johnson & Johnson K.K. Medical Company

Division name

Clinical Development & PMS

Zip code

Address

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

TEL

03-4411-6789

Homepage URL

Email

kyagi1@its.jnj.com

Institute

Johnson & Johnson K.K. Medical Company

Institute

Department

Personal name

Organization

Johnson & Johnson K.K. Medical Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT01895634

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

07

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

04

Month

10

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

01

Day

Last modified on

2015

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012987