UMIN-ICDS Clinical Trial

Public title

A multicenter, prospective registry study on the efficacy and safety of mechanical thrombectomy using pRESET and Esperance for acute cerebral artery occlusion

Acronym

IMPRESS Japan study

Scientific Title

A multicenter, prospective registry study on the efficacy and safety of mechanical thrombectomy using pRESET and Esperance for acute cerebral artery occlusion

Scientific Title:Acronym

IMPRESS Japan study

Region

Japan

Condition

(acute ischemic stroke)

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To prospectively evaluate, in a multicenter real-world setting, the efficacy (e.g., successful reperfusion defined as mTICI 2b or higher) and safety of mechanical thrombectomy using pRESET and/or Esperance as first-line devices in patients with acute cerebral artery occlusion, by first-line treatment strategy (combined use / Esperance alone) and by occlusion site. Exploratory objectives include describing procedural strategy transitions after an unsuccessful first pass and the association between procedural step times and outcomes.

Basic objectives2

Others

Basic objectives -Others

Evaluation of efficacy and safety

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Successful reperfusion rate (mTICI 2b or higher) at the end of the procedure, centrally and independently adjudicated by the image adjudication committee based on DSA images.

Key secondary outcomes

[Efficacy] Excellent reperfusion (mTICI 2c or higher) at the end of the procedure; successful reperfusion (mTICI 2b or higher) by first-line treatment, and excellent reperfusion (mTICI 2c or higher) by first-line treatment and at the end of the procedure; favorable outcome (mRS 0-2) at 90 (+/-30) days after the procedure; time from puncture to the start of the first pass; time from puncture to successful reperfusion (or final angiography if not achieved); association between puncture-to-first-pass time and 90-day favorable outcome; First Pass Effect (mTICI 2c/3 with a single pass) rate; 90-day favorable outcome in patients achieving FPE; rate of rescue treatment using non-first-line devices/techniques; change in NIHSS from pre-procedure to 24 hours after the procedure. [Safety] Neurological deterioration (NIHSS increase of 4 or more) within 24 hours; symptomatic intracranial hemorrhage (sICH) within 24 hours; all-cause mortality within 90 days after the procedure; incidence of adverse events related to pRESET and Esperance.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

130

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria: (1) Aged 20 years or older. (2) Patients who underwent acute recanalization therapy (mechanical thrombectomy) for cerebral artery occlusion in which pRESET/pRESET Delta or Esperance 3+/5F/6F/pHLO was used as the first-line (first-pass) device; specifically, the first pass was performed with Esperance 3+/5F/6F/pHLO alone, or with the combination of pRESET/pRESET Delta and Esperance 3+/5F/6F/pHLO (first-line use of pRESET alone or of other thrombectomy devices is not eligible; PTA balloons are not regarded as thrombectomy devices, and patients in whom pRESET or Esperance was used after PTA are eligible). (3) Written informed consent obtained from the patient or a legally acceptable representative. (4) Patients expected to be evaluable throughout the 90-day observation period after the procedure.

Key exclusion criteria

Patients who meet any of the following criteria are excluded: (1) Patients in whom a medical device not approved in Japan was used. (2) Patients judged by the site principal investigator to be unsuitable for participation due to serious comorbidities or other reasons.

Target sample size

1250

Name of lead principal investigator

1st name	Shinichi
Middle name
Last name	Yoshimura

Organization

Hyogo Medical University

Division name

Department of Neurosurgery

Zip code

663-8501

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798456458

Email

impress@hyo-med.ac.jp

Name of contact person

1st name	Kazutaka
Middle name
Last name	Uchida

Organization

Hyogo Medical University

Division name

Department of Neurosurgery

Zip code

663-8501

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798456458

Homepage URL

Email

impress@hyo-med.ac.jp

Institute

Hyogo Medical University

Institute

Department

Personal name

Organization

Japan Lifeline Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee, Hyogo Medical University

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

Tel

0798456111

Email

rinri@hyo-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

07

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

Preinitiation

Date of protocol fixation

2026

Year

07

Month

28

Day

Date of IRB

Anticipated trial start date

2026

Year

09

Month

01

Day

Last follow-up date

2028

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter, prospective, non-interventional observational study (registry). Patients with acute cerebral artery occlusion who undergo mechanical thrombectomy using pRESET and/or Esperance as first-line devices in routine clinical practice and who meet the eligibility criteria are prospectively enrolled at each participating site. All assessments are performed within the scope of routine clinical practice, and no additional examinations or visits are required for the study. Clinical data (patient characteristics, procedural information, imaging, NIHSS, mRS, etc.) are collected using an electronic data capture (EDC) system. Reperfusion (mTICI) and ASPECTS are centrally adjudicated by an independent image adjudication committee based on DSA and CT/MRI images. The observation period for each patient is 90 days after the procedure, and the enrollment period is from September 1, 2026 to May 31, 2028.

Registered date

2026

Year

08

Month

07

Day

Last modified on

2026

Year

08

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071548