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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036174
Receipt No. R000041202
Scientific Title Usage of Contemporary Drug-Eluting Stent by Japanese Interventional Radiologists for Femoropopliteal In-Stent Restenosis lesions
Date of disclosure of the study information 2019/03/12
Last modified on 2019/04/11

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Basic information
Public title Usage of Contemporary Drug-Eluting Stent by Japanese Interventional Radiologists for Femoropopliteal In-Stent Restenosis lesions -Prospective multicenter study-
Acronym COMBAT-ISR study
Scientific Title Usage of Contemporary Drug-Eluting Stent by Japanese Interventional Radiologists for Femoropopliteal In-Stent Restenosis lesions
Scientific Title:Acronym COMBAT-ISR prospective multicenter study
Region
Japan

Condition
Condition Femoropopliteal In-Stent Restenosis
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the outcomes of ELUVIA drug eluting vascular stent treatment for femoropopliteal in-stent restenosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Primary patency at 12-month follow-up
Key secondary outcomes 1)Technical success rate
2)Major adverse event within 30 days
3)Freedom from target lesion revascularization at 6,12 and 24 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1. Patients were treated with the ELUVIA drug eluting vascular stent (Boston Scientific, Marlborough, MA, USA, Indiana) The protocol specified planned treatment with a maximum of 3 ELUVIA drug eluting vascular stents per patient (maximum length 360 mm).
2. Pre and post dilation were performed at the interventionalist discretion.
3. Unfractionated heparin was administered during the procedure to maintain an activated clotting time over 250 second.
4. Dual antiplatelet agent (Aspirin 81 to 100 mg and Clopidogrel 75 mg) was administered at least 24 h before the procedure. Following treatment, Dual antiplatelet therapy was continued for 90 days and mono antiplatelet therapy was continued indefinitely.
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria were age >= 40 years, symptomatic PAD (Rutherford-Becker category 2 to 5), ISR >50% in the SFA and P1 segment of the popliteal artery, and a distal run off of at least 1 artery
Key exclusion criteria Exclusion criteria were inability to give written informed consent; known allergy, hypersensitivity, or intolerance to radiologic contrast media, aspirin, clopidogrel or ticlopidine, and paclitaxel; and creatinine >2.5 mg/dl (except hemodialysis patients).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name TAKAYAMA
Middle name
Last name KATSUTOSHI
Organization Ishinkai Yao General Hospital
Division name Department of Radiology and Interventional neuroradiology
Zip code 581-0036
Address 1-41 Numa Yao city, Japan
TEL 81-72-948-2500
Email takayamaneuroivs@par.odn.ne.jp

Public contact
Name of contact person
1st name TAKAYAMA
Middle name
Last name KATSUTOSHI
Organization Ishinkai Yao General Hospital
Division name Department of Radiology and Interventional neuroradiology
Zip code 581-0036
Address 1-41 Numa Yao city, Japan
TEL 81-72-948-2500
Homepage URL
Email takayamaneuroivs@par.odn.ne.jp

Sponsor
Institute Department of Radiology and Interventional neuroradiology,Ishinkai Yao General Hospital
Department of Radiology and IVR center, Nara Medical University
Institute
Department

Funding Source
Organization Department of Radiology and Interventional neuroradiology,Ishinkai Yao General Hospital
Department of Radiology and IVR center, Nara Medical University
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 Ishinkai Yao General Hospital
Address 1-41 Numa Yao city, Japan
Tel 81-72-948-2500
Email takayamaneuroivs@par.odn.ne.jp

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 参加予定病院
医真会八尾総合病院(大阪府)
奈良県立医科大学(奈良県)
住友病院(大阪府)
土谷総合病院(広島県)
神戸大学病院(兵庫県)
鳥取大学病院(鳥取県)
東海大学医学部付属八王子病院(神奈川県)
姫路循環器病センター(兵庫県)
慶応大学(東京都)
日本医科大学千葉北総病院(千葉県)
岩手医科大学(岩手県)
市立旭川病院(北海道)
日本医科大学武蔵小杉病院(神奈川県)
和歌山県立医科大学(和歌山県)
松江生協病院(島根県)
大分大学附属病院(大分県)


Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 12 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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 20 Day
Date of IRB
2019 Year 03 Month 11 Day
Anticipated trial start date
2019 Year 03 Month 11 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 12 Day
Last modified on
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041202

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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