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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023017
Receipt No. R000026512
Scientific Title Safety and efficacy of drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions
Date of disclosure of the study information 2016/07/04
Last modified on 2018/06/14

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Basic information
Public title Safety and efficacy of drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions
Acronym Drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions
Scientific Title Safety and efficacy of drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions
Scientific Title:Acronym Drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions
Region
Japan

Condition
Condition calcified coronary stenotic lesions
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of drug-coated balloon following high-speed rotational atherectomy in patients with calcified coronary stenoses.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary procedure success rate
Late lumen loss
Restenosis rate
Key secondary outcomes

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
Maneuver
Interventions/Control_1 High-speed rotational atherectomy is performed using Rotablator for calcified coronary lesions. Subsequently, drug-coated balloon is used following balloon angioplasty.
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 Moderate to severe calcified coronary stenotic lesions
Key exclusion criteria 1) Myocardial infarction within 7 days
2) Cardiogenic shock or hemodynamic instability
3) Unprotected left main lesions
4) In-stent restenoses
5) Reference vessel diameter < 2.0 mm
6) No indication for percutaneous coronary intervention
7) Other conditions judged inappropriate by the attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Shimada
Organization Shiroyama Hospital
Division name Cardiovascular Center
Zip code
Address 2-8-1 Habikino, Habikino-city, Osaka
TEL 072-958-1000
Email shimada@shiroyama-hsp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Kino
Organization Shiroyama Hospital
Division name Cardiovascular Center
Zip code
Address 2-8-1 Habikino, Habikino-city, Osaka
TEL 072-958-1000
Homepage URL
Email kino@shiroyama-hsp.or.jp

Sponsor
Institute Shiroyama Hospital
Institute
Department

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
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
2016 Year 07 Month 04 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026512

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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