UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046511 |
|---|---|
| Receipt number | R000052268 |
| Scientific Title | Late Vascular Response Following Endovascular Treatment with Drug-coating Balloon for Femoropopliteal Artery Lesions as Assessed by Intravascular Ultrasound |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2021/12/28 19:02:21 |
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Basic information
Public title
Late Vascular Response Following Endovascular Treatment with Drug-coating Balloon for Femoropopliteal Artery Lesions as Assessed by Intravascular Ultrasound
Acronym
ENLARGE study
Scientific Title
Late Vascular Response Following Endovascular Treatment with Drug-coating Balloon for Femoropopliteal Artery Lesions as Assessed by Intravascular Ultrasound
Scientific Title:Acronym
ENLARGE study
Region
| Japan |
Condition
Condition
Peripheral Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To evaluate the long-term vascular response after EVT for femoropopliteal artery lesions with DCB.
2. To assess the predictors of late lumen enlargement and restenosis after EVT for femoropopliteal artery lesions with DCB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in IVUS-derived lumen volume index (1-year follow up - post EVT)
Key secondary outcomes
Change in vessel volume index (1-year follow-up - post-EVT)
Change in plaque volume index (1-year follow-up - post-EVT)
Change in mean lumen area (1-year follow-up - post-EVT)
Change in mean vessel area (1-year follow-up - post-EVT)
Change in mean plaque area (1-year follow-up - post-EVT)
Change in lumen volume index (post-EVT - baseline)
Change in vessel volume index (post-EVT - baseline)
Change in plaque volume index (post-EVT - baseline)
Change in mean lumen area (post-EVT - baseline)
Change in vessel area (post-EVT - baseline)
Change in mean plaque area (post-EVT - baseline)
Mean dissection angle at post-EVT
Maximum dissection angle at post-EVT
Mean dissection angle at 1-year
Maximum dissection angle at 1-year
Incidence of late lumen enlargement
Restenosis at 1 year as assessed by duplex ultrasound (PSVR: peak systolic velocity rate > 2.4m/s)
Late lumen loss (MLD at follow-up - MLD at post-EVT) by QVA
Acute gain (MLD at post-EVT - MLD at baseline) by QVA
Predictors for LLE at 1 year
Predictors for restenosis at 1 year
All-cause death, cardiac death, myocardial infarction, stroke, revascularization, amputation
Sub-group analysis:
Lesion length>20mm
Plaque burden>70%
Calcification angle>180
TASC classification
Hemodialysis
Diabetes mellitus
Sex
Small vessel
%diameter stenosis at post-DCB
Plaque type (lipid vs. fibrous vs. calcification)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with symptomatic PAD undergoing EVT for superficial femoral artery or proximal popliteal artery with DCB.
2. Age 20 years or older.
Key exclusion criteria
1. Restenosis lesion.
2. Lesion treated with any stents.
3. Critical limb ischemia.
4. Life expectancy less than 1 year.
5. Pregnant or breastfeeding.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263-37-3486
yasushi522@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Machida |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263-37-3486
Homepage URL
matchy0925@icloud.com
Sponsor or person
Institute
Department of Cardiovascular Medicine, Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Research Ethics Committee, Shinshu University Faculty of Medicine
Address
3-1-1, Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-u.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
信州大学医学部附属病院（長野県）、長野市民病院（長野県）、長野赤十字病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2021 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052268
