UMIN-CTR Clinical Trial

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

Peripheral Arterial disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kameda Medical Center

Institute

Department

Personal name

Organization

TOkyo taMA peripheral vascular intervention research COmraDE: Toma-code

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

01

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2021

Year

01

Month

05

Day

Last modified on

2021

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048846