UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037284
Receipt number R000042487
Scientific Title Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography
Date of disclosure of the study information 2019/07/05
Last modified on 2023/12/09 13:37:23

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Basic information

Public title

Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography

Acronym

DIRO trial

Scientific Title

Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography

Scientific Title:Acronym

DIRO trial

Region

Japan


Condition

Condition

Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety and efficacy of percutaneous coronary intervention with Diamondback for calcified lesions guided by optical coherence tomography compared to Rotablator.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tissue modification and stent outcomes assessed by OCT.

Key secondary outcomes

Procedural complications (coronary artery perforation, slow/no flow, dissections during procedure and peri-procedural myocardial infarction) and procedural time and contrast volume. Major adverse cardiovascular events at 8 months after the procedure


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Patients treated with diamondback

Interventions/Control_2

Patients treated with rotablator

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

18 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) All patients should be over 18 years of age.
2) Patients with stable coronary artery disease must have a clinical indication for percutaneous coronary intervention.
3) The target lesion must be a de novo calcified lesion that has calcification more than 180 degree of arc assessed by OCT.
4) Moderate or severe calcification by angiogram, if OCT does not cross the lesion.

Key exclusion criteria

1)Ostial left main artery or ostial right coronary artery lesions.
2)Female patients of childbearing potential.
3)Life expectancy less than 12 months.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masami
Middle name
Last name Nishino

Organization

Osaka Rosai Hospital

Division name

Cardiology

Zip code

5918025

Address

1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan

TEL

072-252-3561

Email

mnishino@osakah.johas.go.jp


Public contact

Name of contact person

1st name Naotaka
Middle name
Last name Okamoto

Organization

Osaka Rosai Hospital

Division name

Cardiology

Zip code

5918025

Address

1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan

TEL

072-252-3561

Homepage URL


Email

okamo10nao@osakah.johas.go.jp


Sponsor or person

Institute

Osaka Rosai Hospital, Cardiology

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

Osaka Rosai Hospital

Address

1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan

Tel

072-252-3561

Email

okamo10nao@osakah.johas.go.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

2019 Year 07 Month 05 Day


Related information

URL releasing protocol

https://www.jacc.org/doi/10.1016/j.jcin.2023.06.016

Publication of results

Published


Result

URL related to results and publications

https://www.jacc.org/doi/10.1016/j.jcin.2023.06.016

Number of participants that the trial has enrolled

100

Results

The stent expansion was significantly greater in the RA group vs the OA group (99.5% vs 90.6%; P = 0.02). The maximum atherectomy area was significantly larger in the RA group than in the OA group (1.34 [IQR: 1.02-1.89] mm2 vs 0.83 [IQR: 0.59-1.11] mm2; P = 0.004). The procedural outcomes and clinical events at 8 months did not differ between the groups. The vascular healing was sufficient in both groups.

Results date posted

2023 Year 12 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

There was no significant difference between the 2 groups regarding the age, sex, coronary risk factors, and past medical history. The ejection fraction assessed byechocardiography was similar. The laboratory data including the low-density lipoprotein cholesterol, glycosylated hemoglobin, hemoglobin, creatinine, and NT-pro BNP were also comparable.

Participant flow

Patients were recruited from all patients scheduled to undergo PCI in our institution between August 2019 and October 2021. Eligible patients were randomly allocated 1:1 to a lesion preparation with RA vs OA.

Adverse events

One patient had a coronary perforation after the OA. No one had a tamponade and death during the procedure.

Outcome measures

The stent expansion was significantly greater in the RA group vs the OA group (99.5% vs 90.6%; P = 0.02). The maximum atherectomy area was significantly larger in the RA group than in the OA group (1.34 [IQR: 1.02-1.89] mm2 vs 0.83 [IQR: 0.59-1.11] mm2; P = 0.004). The procedural outcomes and clinical events at 8 months did not differ between the groups. The vascular healing was sufficient in both groups.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 07 Month 05 Day

Date of IRB

2019 Year 08 Month 09 Day

Anticipated trial start date

2019 Year 07 Month 05 Day

Last follow-up date

2022 Year 06 Month 30 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 07 Month 05 Day

Last modified on

2023 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042487


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name