UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048673 |
|---|---|
| Receipt number | R000055463 |
| Scientific Title | Jetstream Atherectomy System post market surveillance |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2026/08/27 15:21:32 |
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Basic information
Public title
Jetstream Atherectomy System post market surveillance
Acronym
Jetstream Atherectomy System post market surveillance
Scientific Title
Jetstream Atherectomy System post market surveillance
Scientific Title:Acronym
Jetstream Atherectomy System post market surveillance
Region
| Japan |
Condition
Condition
Superficial femoral and proximal popliteal artery disease
Classification by specialty
| Cardiology | Surgery in general | Vascular surgery |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this surveillance is to understand the situation of occurrence of failure in order to ensure the safety of the product, as well as to collect data on the safety and efficacy of this product in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
- Occurrence rate of periprocedural complications (Distal emboli, etc.) related to Jetstream Atherectomy System
- Procedural success
- Mortality rate
Key secondary outcomes
- All death, target limb amputation and target lesion revascularization (TLR) during the follow-up (procedure, pre-discharge, 6, 12, 24 months) period
- SAE for which relation to the Jetstream Atherectomy System or procedures cannot be denied during the follow-up period
- Device malfunction and adverse event for which the relation to Jetstream Atherectomy System or procedures cannot be denied during the follow-up period
- Duration of Jetstream Atherectomy System related DAPT at pre-procedure and during the follow-up period
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 intended to be treated with Jetstream Atherectomy System
Key exclusion criteria
Not applicable
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kawahara |
Organization
Boston Scientific Japan K.K.
Division name
Clinical Affairs
Zip code
164-0001
Address
4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-6853-7500
Kazuo.Kawahara@bsci.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakamoto |
Organization
Boston Scientific Japan K.K.
Division name
Clinical Affairs
Zip code
164-0001
Address
4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-6853-7500
Homepage URL
Hiroshi.Sakamoto@bsci.com
Sponsor or person
Institute
Boston Scientific Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2022 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00380-025-02612-9
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00380-025-02612-9
Number of participants that the trial has enrolled
154
Results
The results of this study did not identify any safety or effectiveness concerns that would require revision of the package insert.
Results date posted
| 2026 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients for whom treatment with the device was attempted, defined as insertion of the catheter into the body, until the enrollment of at least 150 patients was achieved.
Participant flow
Patients shall be considered enrolled in the study at the time the study device catheter is inserted into the body.
Adverse events
Of the serious adverse events reported in this study, distal embolization was reported in two patients (two events; 1.3%) and restenosis of the treated lesion was reported in one patient (one event; 0.6%), and a causal relationship to the device or procedure could not be excluded for these events.
Outcome measures
Periprocedural complication rates associated with use of the device (e.g., distal embolization), procedural success, and mortality.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 10 | Month | 25 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 03 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2022 | Year | 08 | Month | 16 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055463
