UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational comparison study between endovascular treatment devices for femoropopliteal arterial disease
Acronym	Toma-Code FP study
Scientific Title	Prospective observational comparison study between endovascular treatment devices for femoropopliteal arterial disease
Scientific Title:Acronym	Toma-Code FP study
Region	Japan

Condition
Condition	Peripheral Arterial disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the noninferiority of the patency rate in the patients underwent endovascular treatment for superficial femoral artery with following 3 comparison study. Cohort A: noninferiority of drug coated balloon to drug eluting stent, Cohort B: noninferiority of interwoven nitinol stent to drug eluting stent, Cohort C: noninferiority of drug coated balloon to interwoven nitinol stent
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	composite outcomes of restenosis(defined as 20% or greater decrease in the ankle brachial index), clinical driven target lesion revascularization, or unplanned lower extremity major amputation at 12 months after interventions
Key secondary outcomes	all cause death, clinical driven target lesion revascularization, unplanned lower extremity major amputation, ankle brachial index, and peak systolic velocity ratio from duplex ultrasound at 6, 12, 24, 36 months after interventions

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects has symptomatic peripheral arterial disease of Rutherford category 2-5 2. Subject has a de novo or restenotic lesion with severer than 70% stenosis documented angiographically and no prior stent in the target lesion 3. Target lesion is limited at superficial femoral artery and does not exceed the medial femoral epicondyle or popliteal artery 4. Patency of at least 1 infrapopliteal artery to the ankle in continuity with the native femoropopliteal artery 5. A guidewire has successfully traversed the target treatment
Key exclusion criteria	1. Subjects who rejected to participate this study through Opt-out method applied by a poster 2. Life expectancy <12 months 3. Pregnancy, suspected pregnancy, or breastfeeding during study period 4. Presence of cerebrovascular accident or myocardial infarction within 1 month of procedure 5. Untreated external iliac artery inflow lesion 6. Acute occlusive intraluminal thrombosis of the proposed lesion site. 7. Evidence of an aneurysm at the target lesion site
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ueshima
Organization	Kameda Medical Center
Division name	Cardiology
Zip code	296-8602
Address	929 Higashi-cho Kamogawa City Chiba Japan
TEL	+81-4-7092-2211
Email	daisuke_ueshima@yahoo.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ueshima
Organization	Kameda Medical Center
Division name	Cardiology
Zip code	296-8602
Address	929 Higashi-cho Kamogawa City Chiba Japan
TEL	+81-4-7092-2211
Homepage URL
Email	daisuke_ueshima@yahoo.co.jp

Sponsor
Institute	Kameda Medical Center
Institute
Department

Funding Source
Organization	TOkyo taMA peripheral vascular intervention research COmraDE: Toma-code
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	Kameda Medical Center clinical research review board
Address	929 Higashi-cho Kamogawa City Chiba Japan
Tel	+81-4-7092-2211
Email	clinical_research@kameda.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	2021 Year 01 Month 05 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	2020 Year 12 Month 22 Day
Date of IRB	2020 Year 12 Month 23 Day
Anticipated trial start date	2020 Year 12 Month 23 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Statistical analysis This study predetermines to adjust baseline characteristics with propensity score matching, the following confound factors are used for calculating the propensity score; gender, age, body mass index, comorbidity(hypertension, diabetes mellitus, hemodialysis), Rutherford classification, disability scale(able to walk, chair-bound, or bedridden), smoking habit, ankle brachial pressure index, lesion length, reference diameter, stenosis or occlusion, Peripheral arterial calcium score (PACSS score), number of outflow below-the-knee arteries, Post balloon angioplasty dissections grade (NHLBI grade). The data center performed propensity matching in each cohort when all 3 groups (DCB, DES, or INS group) include more than 160 patients (1 to 1 without replacement matching). The enrollment continues until all matched group have 158 patients. This study uses PROBE (Prospective Randomised Open Blinded Endpoint) design. Sample size Sample size is based on an expected primary outcome (composite outcomes of restenosis; defined as 20% or greater decrease in the ankle brachial index, clinical driven target lesion revascularization, or unplanned lower extremity major amputation) rate at 12 months after interventions of 10% in the each group. Roughly 142 patients per group are required for an 80% power to demonstrate that the upper limit of the 95% CI for a treatment different is 10% or less (respecified non-inferiority margin for this primary outcome). This calculation is based on a one-sided non-inferiority test at 2.5% significant level. Allowing for a 10% dropout rate for the primary outcome during 12 months follow-up period, 158 patients are required. Considering exclusion through propensity score matching, we presumed about 600 patients should be totally included. When non-inferiority is confirmed, we perform superiority test.

Management information
Registered date	2021 Year 01 Month 05 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048846

Research Plan
Registered date	File name
2021/01/06	20201221 SFA研究計画.docx

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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