UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056711 |
|---|---|
| Receipt number | R000064770 |
| Scientific Title | The relationship between the clinical outcomes of EVT and the Adductor Canal |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/14 15:43:48 |
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Basic information
Public title
The relationship between the clinical outcomes of EVT and the Adductor Canal
Acronym
P1 study
Scientific Title
The relationship between the clinical outcomes of EVT and the Adductor Canal
Scientific Title:Acronym
P1 study
Region
| Japan |
Condition
Condition
lower extremity arterial disease (LEAD)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endovascular treatment (EVT) of lower extremity arterial disease (LEAD) has improved dramatically in recent years due to advances in the equipment available for treatment, thus we naw can select treatment strategies according to patient and lesion characteristics. In particular, there are many treatment options for EVT of the femoro-popliteal artery region, including drug-coated balloons (DCB), drug-eluting stents (DES), bare metal stents (BMS) and stent grafts (SG), and many previous studies have reported the factors influencing outcomes. Factors that may affected clinical outcomes of EVT specific to lower limb vessels include walking and joint flexion/extension, which can cause vessel torsion, and the patient's level of activities of daily living (ADL) and the location of the lesion may also affect outcomes. The popliteal artery is anatomically defined as the artery from the adductor canal hiatus to the branching of the anterior tibial artery, and is further subdivided into P1 region from the adductor canal hiatus to the suprapatellar border, P2 region at the joint and P3 region below that. It has been reported that vascular torsion occurs predominantly in the P1 region, where the superficial femoral artery fixed in the adductor canal transitions to the popliteal artery, and previous studies have in fact reported reduced outcomes with stents and DCBs in the popliteal artery region. However fewer papers mention the relationship between the adductor canal and clinical outcomes. Although the joint flexion of the popliteal artery is in the P2 region, assuming that the main cause of arterial restenosis is torsion, the P1 region is responsible for worsening clinical outcomes in the popliteal artery, and investigating promising treatment options for this region will improve the clinical outcomes of EVT in the popliteal artery region. The aim of the study is to identify differences in clinical outcomes and desirable treatment devices in each resion (P1/P2/P3).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary patency
Key secondary outcomes
major adverse limb events (MALE), target lesion revascularization (TLR), target vessel revascularization (TVR), re-occlusion rate
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
Patients aged 20 years and over who have undergone endovascular treatment for lower extremity artery disease within the observation period. Patients whose target lesion was chronic total occlusion or stenosis of only the popliteal artery.
Key exclusion criteria
Patients whose target lesion was in-stent restenosis or occlusion. Patients with non-atherosclerotic disease including supplemental popliteal artery syndrome, acute limb infarction or popliteal artery aneurysm. Pregnant patients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kan |
| Middle name | |
| Last name | Zen |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Department of Cardiology
Zip code
6028566
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5111
k-zen@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kan |
| Middle name | |
| Last name | Zen |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Department of Cardiology
Zip code
602-8566
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5111
Homepage URL
k-zen@koto.kpu-m.ac.jp
Sponsor or person
Institute
University Hospital, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine Clinical Ethics Committee
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
Tel
0752515337
rinri@koto.kpu-m.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
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | 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
Nothing special.
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064770
