UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018862 |
|---|---|
| Receipt number | R000021280 |
| Scientific Title | Prospective angioscopic Observation of vascular wall Re-intimal Coverage over DES IN the Infra-inguinal lesion |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2015/09/02 14:00:21 |
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Basic information
Public title
Prospective angioscopic Observation of vascular wall Re-intimal Coverage over DES IN the Infra-inguinal lesion
Acronym
PORCINII trial
Scientific Title
Prospective angioscopic Observation of vascular wall Re-intimal Coverage over DES IN the Infra-inguinal lesion
Scientific Title:Acronym
PORCINII trial
Region
| Japan |
Condition
Condition
Peripheral Arterial Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate neoitimal coverage and intra-stent thrombi at 2 months after iplantation of Zilver PTX stent at SFA or PA by angioscopic analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neoitimal coverage and intra-stent thrombi by angioscopic analysis.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) PAD patients undergoing DES(Zilver PTX) inplantation at SFA or PA
2) DES inplantation site can be applyed angioscopic analyse.
3) Patients who can take both of aspirin and clopidogrel.
4) Patients who have provided informed consent written by themselves.
Key exclusion criteria
1) Patients who had prior stenting, or subject limb need DES and BMS at once.
2) Paients who need other blood thinner besides aspirin and clopidogrel.
3) Patients who participate in clinical trials(besides PhIV).
4) Female patient during pregnancyor breast-feeding.
5) Patients who need hemodialysis.
6) Patients judged as unsuitable for the study by the investigator for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Medicine
Zip code
Address
3-1-69, Inabaso, Amagasaki, Hyogo, Japan
TEL
06-6416-1221
iida.osa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Medicine
Zip code
Address
3-1-69, Inabaso, Amagasaki, Hyogo, Japan
TEL
06-6416-1221
Homepage URL
iida.osa@gmail.com
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo, Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe University, Saiseikai Nakatsu Hospital, Hyogo college of medicine, Omihachiman
Community Medical Center, Kyoto university
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
関西労災病院（兵庫県）、神戸大学病院(兵庫県)、済生会中津病院（大阪府）、兵庫医科大学（兵庫県）、近江八幡市立総合医療センター（滋賀県）、京都大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 31 | 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 | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
Study design: Cohort study
Subjects: PAD patients who satisfy inclusion/exclusion criteria and have
given written informed consent by themselves
Observation: angioscopic findings 2 months after stent implantation, PRU
Management information
Registered date
| 2015 | Year | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021280
