UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023017
Receipt number 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 2023/06/28 15:50:29

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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

RotaCut-Sequent study

Scientific Title

Safety and efficacy of drug-coated balloon angioplasty following high-speed rotational atherectomy in calcified coronary lesions

Scientific Title:Acronym

RotaCut-Sequent study

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 Yoshihisa
Middle name
Last name Shimada

Organization

Shiroyama Hospital

Division name

Cardiovascular Center

Zip code

583-0872

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 Naoto
Middle name
Last name Kino

Organization

Shiroyama Hospital

Division name

Cardiovascular Center

Zip code

583-0872

Address

2-8-1 Habikino, Habikino-city, Osaka

TEL

072-958-1000

Homepage URL


Email

kino@shiroyama-hsp.or.jp


Sponsor or person

Institute

Shiroyama Hospital

Institute

Department

Personal name



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

Shiroyama hospital

Address

2-8-1 Habikino, Habikino-city, Osaka

Tel

072-958-1000

Email

shimada@shiroyama-hsp.or.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



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

2023 Year 06 Month 28 Day



Link to view the page

Value
https://center6.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