UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034819
Receipt No. R000039707
Scientific Title Impact of IVUS-derived Vessel Size on Long-term Outcomes after Stent Implantation in Femoropopliteal Artery Lesions
Date of disclosure of the study information 2018/11/11
Last modified on 2019/05/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Impact of IVUS-derived Vessel Size on Long-term Outcomes after Stent Implantation in Femoropopliteal Artery Lesions
Acronym IVUS findings predicting long-term stent patency
Scientific Title Impact of IVUS-derived Vessel Size on Long-term Outcomes after Stent Implantation in Femoropopliteal Artery Lesions
Scientific Title:Acronym IVUS findings predicting long-term stent patency
Region
Japan

Condition
Condition peripheral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to identify intravascular ultrasound (IVUS) findings that can predict long-term stent patency after endovascular therapy (EVT) in femoropopliteal (FP) lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes primary patency at 24 months
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 Rutherford categories 2-5
de novo FP lesions
Key exclusion criteria Rutherford categories 1
restenotic lesions
Target sample size 274

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kojiro Miki
Organization Hyogo College of Medicine
Division name Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, Japan
TEL 0798-65-6553
Email hpxkg043@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kojiro Miki
Organization Hyogo College of Medicine
Division name Division of Cardiovascular Medicine and Coronary Heart Disease
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8131, Japan
TEL 0798-65-6553
Homepage URL
Email hpxkg043@ybb.ne.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Other
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
2018 Year 11 Month 11 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 274
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 No longer recruiting
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
2018 Year 09 Month 01 Day
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A total of 335 de novo FP lesions in 274 patients who underwent successful EVT with self-expanding stents using IVUS at Hyogo College of Medicine were reviewed. The primary outcome was primary patency at 24 months.

Management information
Registered date
2018 Year 11 Month 08 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039707

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.