UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060656 |
|---|---|
| Receipt number | R000069380 |
| Scientific Title | Prospective study of the clinical outcome of drug-coated Balloons for complEx lEsions in The reaL world clinical practicE |
| Date of disclosure of the study information | 2026/02/12 |
| Last modified on | 2026/02/12 15:24:04 |
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Basic information
Public title
BEETLE
Acronym
BEETLE
Scientific Title
Prospective study of the clinical outcome of drug-coated Balloons for complEx lEsions in The reaL world clinical practicE
Scientific Title:Acronym
BEETLE
Region
| Japan |
Condition
Condition
DCB: Drug Coated Balloon
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical outcomes of DCB monotherapy for lesions with longer lesion lengths or occlusion lengths, previously classified as TASC II C/D lesions, and to explore the morphological characteristics of these lesions associated with clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
at 12-month follow-up
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 20 years or older
2) Patients with symptomatic lower extremity peripheral arterial disease (Rutherford classification 2-5)
3) Lesions present from the superficial femoral artery to the distal popliteal artery
4) Femoral-popliteal artery lesions corresponding to TASC II C/D
5) Use of a drug-coated balloon (DCB) as the final device to fully cover the lesion
Key exclusion criteria
1) Lesions involving aneurysms in target vessels
2) Expected survival period of 12 months or less
3) Cases of stent restenosis
4) Cases of acute lower extremity arterial occlusion
5) Cases where a debulking device is planned for use
6) Cases where provisional stent placement is planned
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hayakawa |
Organization
Asahi General Hospital
Division name
Cardiology
Zip code
289-2511
Address
1326 I, Asahi City, Chiba Prefecture
TEL
0479-63-8111
haya.naoki1981@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Hayakawa |
Organization
Asahi General Hospital
Division name
Cardiology
Zip code
289-2511
Address
1326 I, Asahi City, Chiba Prefecture
TEL
0479-63-8111
Homepage URL
haya.naoki1981@gmail.com
Sponsor or person
Institute
Asahi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi General Hospital
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
Asahi General Hospital
Address
1326 I, Asahi City, Chiba Prefecture
Tel
0479-63-8111
haya.naoki1981@gmail.com
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 | 02 | Month | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Observational study
Target population:DCB: Drug Coated Balloon
Management information
Registered date
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069380
