UMIN-CTR Clinical Trial

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
Email	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
Email	matchy0925@icloud.com

Sponsor
Institute	Department of Cardiovascular Medicine, Shinshu University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052268