UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059284 |
|---|---|
| Receipt number | R000067794 |
| Scientific Title | Prevention of the elastic recoil after balloon angioplasty for infrapopliteal zone in patients with chronic limb threateing ischemia |
| Date of disclosure of the study information | 2025/10/03 |
| Last modified on | 2025/10/03 20:10:09 |
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Basic information
Public title
Prevention of the elastic recoil after balloon angioplasty for infrapopliteal zone in patients with chronic limb threateing ischemia
Acronym
RECOIL ZERO study
Scientific Title
Prevention of the elastic recoil after balloon angioplasty for infrapopliteal zone in patients with chronic limb threateing ischemia
Scientific Title:Acronym
RECOIL ZERO study
Region
| Japan |
Condition
Condition
Chronic limb threatening ischemia (Below-the-knee)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to clarify the incidence of early recoil as an acute treatment outcome in cases undergoing endovascular treatment with a high-pressure balloon for popliteal artery lesions, and to explore its associated factors. We statistically examine the incidence of early recoil as an acute treatment outcome and its associated factors in cases undergoing endovascular treatment with a high-pressure balloon for popliteal artery lesions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence or absence of elastic recoil confirmed by angiography 15 minutes later
Key secondary outcomes
Incidence of procedural complications
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with symptomatic lower limb occlusive atherosclerosis (Rutherford classification 4-6) for whom below-knee arterial EVT is indicated
2) Patients for whom HP-POBA is determined to be the medically optimal treatment (best practice) for symptomatic atherosclerotic lesions in the below-knee arteries, and for whom HP-POBA is actually planned
(Patients may also be enrolled if treatment of other arterial regions is planned concurrently)
Key exclusion criteria
1) Patients for whom limb salvage is unlikely (e.g., due to infection complications)
2) Lesions involving aneurysms in the target vessel
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nakama |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
cardiology
Zip code
279-0001
Address
3-4-32 Todaijima, Urayasu-shi, Chiba, Japan
TEL
047-351-3101
tatsuya_nakama@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | toru |
| Middle name | |
| Last name | matsumura |
Organization
Clinicalcore
Division name
Non
Zip code
103-0002
Address
Dainikyubiru, Bakurocho 1-6-8,. Nihonbashi, chuo-ku, Tokyo, Japan
TEL
03-6667-0250
Homepage URL
matsumura@clinicalcore.jp
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association Tokyo Endovascular Challenging Conference
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
Non
Address
3-4-32 Todaijima, Urayasu-shi, Chiba, Japan
Tel
047-351-3101
Non
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
| 2025 | Year | 10 | Month | 03 | 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 | 03 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation
*Patient Background: Gender, age, height, weight, ADL, smoking habits, comorbidities, medication status, etc.
*Affected Limb Background: Status of lower limb peripheral arterial disease: Rutherford classification, WIFI classification, ABI, SPP, etc.
*Lesion Background: Lesion characteristics (stenosis or occlusion), lesion length, vessel diameter, presence/absence of calcification, etc.
*Treatment Details: Type, diameter, length, inflation time of the high-pressure balloon used; use of intravascular ultrasound (IVUS) or not (if IVUS was performed, include IVUS information)
*Angiographic information (data collected by the study office and analyzed by the core lab)
1)Pre-treatment Minimum luminal diameter (MLD), Reference vessel diameter (RVD), lesion length, presence of calcification (PACSS grade also used for BTK)
2)MLD immediately after HP-POBA
3)MLD from angiography performed 5 minutes and 15 minutes post-treatment. To avoid changes in contrast findings due to the accordion effect, the 15-minute angiography is performed before guidewire removal, and the final angiography is performed after guidewire removal. The QVA from the post-guidewire-removal angiography is used as the main analysis data.
*Post-treatment information: Procedural complications, perioperative (30-day) complications, length of hospital stay, medication adherence, ABI, etc.
*Perioperative and post-treatment events: Death, cerebrovascular death, reintervention due to symptom recurrence (Clinically driven target lesion revascularization rate: CD-TLR), major amputation, acute lower limb ischemia, non-fatal myocardial infarction, cerebral infarction, bleeding events, presence/absence of wound healing, etc.
Management information
Registered date
| 2025 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067794
