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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011551
Receipt No. 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

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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
Institute Kikuna Memorial Hospital
Institute
Department

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
URL(English) https://upload.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


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