UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061455 |
|---|---|
| Receipt number | R000070278 |
| Scientific Title | A Retrospective Comparative Study of Surgical Thrombectomy and Mechanical Aspiration Thrombectomy Using the Japanese National Clinical Database (NCD) |
| Date of disclosure of the study information | 2026/05/06 |
| Last modified on | 2026/05/04 16:06:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Comparative Study of Thrombus Removal Treatments Using the Japanese National Clinical Database
Acronym
NCD Thrombectomy Study in Japan
Scientific Title
A Retrospective Comparative Study of Surgical Thrombectomy and Mechanical Aspiration Thrombectomy Using the Japanese National Clinical Database (NCD)
Scientific Title:Acronym
NCD-Surgical vs Aspiration Thrombectomy Study in Japan
Region
| Japan |
Condition
Condition
Acute Limb Ischemia
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the safety and efficacy of surgical thrombectomy and mechanical aspiration thrombectomy for acute limb ischemia. In particular, we will evaluate whether 30-day mortality and major lower extremity amputation rates after mechanical aspiration thrombectomy are non-inferior to those after surgical thrombectomy. We will also attempt to develop a risk calculator to help determine the optimal treatment strategy for acute limb ischemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day mortality and major lower extremity amputation rates after treatment
Key secondary outcomes
Technical success rate (rate of successful revascularization)
Incidence of perioperative complications
Length of hospital stay
Reocclusion rate
Reintervention rate
6-month overall survival and major lower extremity amputation rates
Long-term survival rate, if available
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included:
Patients who underwent treatment for acute arterial occlusion of the peripheral arteries distal to the aorta between January 1, 2024, and December 31, 2024, and were registered in the National Clinical Database (NCD).
Patients who underwent surgical thrombectomy or mechanical aspiration thrombectomy using the Indigo System.
Age: no restriction.
Sex: no restriction.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from this study:
Patients who decline participation in this study.
Patients who are otherwise deemed unsuitable for inclusion by the principal investigator.
Target sample size
3700
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Obara |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3802
obara.z3@keio.jp
Public contact
Name of contact person
| 1st name | Momoka |
| Middle name | |
| Last name | Shimada |
Organization
General Incorporated Association National Clinical Database
Division name
Secretariat
Zip code
100-0005
Address
20F Marunouchi Trust Tower Main Building, 1-8-3 Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-3233-7459
Homepage URL
office@ncd-core.jp
Sponsor or person
Institute
The Japanese Society for Vascular Surgery Database Management Committee Member
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society for Vascular Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
2893
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
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Surgery-related data without personal identifiable information, maintained by the National Clinical Database Organization, for patients who meet the inclusion criteria
Management information
Registered date
| 2026 | Year | 05 | Month | 05 | Day |
Last modified on
| 2026 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070278
