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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name