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
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
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
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
