UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011551
Receipt number R000013514
Scientific Title A prospective observational multicenter cohort study in patients with SFA lesions who underwent stenting in Kanagawa.
Date of disclosure of the study information 2013/08/23
Last modified on 2014/02/24 10:18:42

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Basic information

Public title

A prospective observational multicenter cohort study in patients with SFA lesions who underwent stenting in Kanagawa.

Acronym

KPTA1-Study

Scientific Title

A prospective observational multicenter cohort study in patients with SFA lesions who underwent stenting in Kanagawa.

Scientific Title:Acronym

KPTA1-Study

Region

Japan


Condition

Condition

peripheral arterial disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aims of the present study are to investigate prospectively the clinical course and outcome of the PAD patients with SFA lesions who underwent stenting in Kanagawa

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Restenosis rate (1 year, 2 year)

Key secondary outcomes

TLR, MACLE (1 year, 2 year)


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

Patient criteria
Patients who meet all of the following criteria will be included in the study:
1. Chronic arteriosclerosis obliterans afflicting the SFA area*
(Rutherford classification 2-6)
*Except for patients with acute (within 1 week after onset)/subacute (2 weeks to 1 month after onset) lower limb ischemia
2. Age: 20 years or older at the time of consent
3. Gender: Male or female
4. Patients who can be monitored for at least 24 months after surgery

Lesion criteria
1. Superficial femoral artery stenosis or occlusive lesions.
2. At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
In addition, patients with bilateral lesions or aorta-iliac artery lesions may be included.
3. Occlusive lesions may be included.

Key exclusion criteria

Patient criteria
Patients who meet any of the following criteria should be excluded from the study:
1.Patients with or at risk of hemorrhagic complications or patients with bleeding* tendency
*Bleeding such as hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage may be aggravated.
2.Pregnant or potentially pregnant women
3. Patients who are not eligible for the study in the opinion of the attending physician.

Lesion criteria
Lesions that meet any of the following criteria should be excluded from the study:
1.Remnant inflow (aorta-iliac artery lesion)
2.Severe calcification (lesions not expected to be appropriately expanded)
3.No arterial runoff below the knee

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Michishita, / Akira Miyamoto

Organization

Yokohama Sakae Kyosai Hospital / Kikuna Memorial Hospital

Division name

Cardiology / Cardiology

Zip code


Address

132 Katsura-cho Sakae-ku Yokohama, Japan / 4-4-27 Kikuna Kohoku-ku Yokohama, Japan

TEL

045-402-7111

Email

qqfw76rd@bell.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasutaka Yamauchi

Organization

Kikuna Memorial Hospital

Division name

Cardiology

Zip code


Address

4-4-27 Kikuna Kohoku-ku Yokohama, Japan

TEL

045-402-7111

Homepage URL


Email

qqfw76rd@bell.ocn.ne.jp


Sponsor or person

Institute

Kikuna Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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


Address


Tel


Email



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

2013 Year 08 Month 23 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

2013 Year 08 Month 21 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

patient's background, ischemia, ABPI, Echo, laboratory test, device, antiplatelet therapy


Management information

Registered date

2013 Year 08 Month 22 Day

Last modified on

2014 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013514


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name