Trial Outcomes & Findings for Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN) (NCT NCT01895634)

NCT ID: NCT01895634

Last Updated: 2016-03-07

Results Overview

Proportion of subjects who had recanalization, TICI 2a or better

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: immediately post procedure
• Results posted on: 2016-03-07

Participant Flow

Participant milestones

Measure	Treatment Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Overall Study STARTED	49
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment n=49 Participants Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Age, Continuous	70.6 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment Japan	49 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately post procedure

Proportion of subjects who had recanalization, TICI 2a or better

Outcome measures

Measure	Treatment n=49 Participants Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Proportion of Patients Who Have Recanalization	36 participants

SECONDARY outcome

Timeframe: immediately post procedure

Outcome measures

Measure	Treatment n=49 Participants Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Proportion of Subject Who Have Clot Migration/Embolization	0 participants

SECONDARY outcome

Timeframe: 90 days post procedure

Population: Missing value was not be imputed (1 missing subject was because of the missing data at 90 days by subject IC withdrawal)

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Outcome measures

Measure	Treatment n=48 Participants Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure	30 participants

SECONDARY outcome

Timeframe: 24-hour post procedure

Population: Missing value was not be imputed (1 missing subject was because of the death within 24 hours)

Outcome measures

Measure	Treatment n=48 Participants Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)	15 participants

SECONDARY outcome

Timeframe: 90 days post-procedure

Outcome measures

Measure	Treatment n=49 Participants Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
All Cause Mortality	2 participants

Adverse Events

Treatment

Serious events: 16 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=49 participants at risk Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Gastrointestinal disorders Intestinal ischaemia	2.0% 1/49 • 90 days post procedure
Gastrointestinal disorders Rectal ulcer	2.0% 1/49 • 90 days post procedure
Infections and infestations Sepsis	2.0% 1/49 • 90 days post procedure
Injury, poisoning and procedural complications Burns third degree	2.0% 1/49 • 90 days post procedure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	2.0% 1/49 • 90 days post procedure
Nervous system disorders Brain stem infarction	2.0% 1/49 • 90 days post procedure
Nervous system disorders Cerebral infarction	8.2% 4/49 • 90 days post procedure
Nervous system disorders Haemorrhage intracranial	4.1% 2/49 • 90 days post procedure
Nervous system disorders Brain oedema	4.1% 2/49 • 90 days post procedure
Nervous system disorders Carotid artery occlusion	2.0% 1/49 • 90 days post procedure
Respiratory, thoracic and mediastinal disorders Hypercapnia	2.0% 1/49 • 90 days post procedure
Vascular disorders Femoral artery aneurysm	2.0% 1/49 • 90 days post procedure
Vascular disorders Haemorrhagic infarction	2.0% 1/49 • 90 days post procedure
Vascular disorders Embolism	2.0% 1/49 • 90 days post procedure
Vascular disorders Iliac artery occlusion	2.0% 1/49 • 90 days post procedure

Other adverse events

Measure	Treatment n=49 participants at risk Intervention Device: Rev-01 Rev-01: Treatment arm patients have used Rev-01 at least once
Blood and lymphatic system disorders Anaemia	16.3% 8/49 • 90 days post procedure
Gastrointestinal disorders Constipation	44.9% 22/49 • 90 days post procedure
Gastrointestinal disorders Diarrhoea	10.2% 5/49 • 90 days post procedure
Gastrointestinal disorders Vomiting	12.2% 6/49 • 90 days post procedure
General disorders Pyrexia	6.1% 3/49 • 90 days post procedure
Hepatobiliary disorders Hepatic function abnormal	8.2% 4/49 • 90 days post procedure
Infections and infestations Urinary tract infection	16.3% 8/49 • 90 days post procedure
Metabolism and nutrition disorders Hypokalaemia	6.1% 3/49 • 90 days post procedure
Musculoskeletal and connective tissue disorders Back pain	6.1% 3/49 • 90 days post procedure
Nervous system disorders Haemorrhage intracranial	22.4% 11/49 • 90 days post procedure
Nervous system disorders Subarachnoid haemorrhage	14.3% 7/49 • 90 days post procedure
Nervous system disorders Cerebral vasoconstriction	6.1% 3/49 • 90 days post procedure
Psychiatric disorders Insomnia	14.3% 7/49 • 90 days post procedure
Skin and subcutaneous tissue disorders Erythema	6.1% 3/49 • 90 days post procedure
Injury, poisoning and procedural complications Intraoperative cerebral artery occlusion	14.3% 7/49 • 90 days post procedure

Additional Information

Depertment Chief, Clinical Operation

Johnson & Johnson K.K. Medical Company

Phone: +81-3-4411-6789

Email: yikeda5@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place