UMIN-CTR Clinical Trial

Public title

Novel DCB for Coronary Artery Disease Trial

Acronym

Novel DCB Trial

Scientific Title

Novel DCB for Coronary Artery Disease Trial

Scientific Title:Acronym

Novel DCB Trial

Region

Japan

Condition

Ishemic cardiac disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Primary objective is to evaluate the safety and effectiveness of the Agent Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Target Lesion Failure (TLF) rate at 6 months post index-procedure. TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

Key secondary outcomes

Clinical endpoints measured at hospital discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
- Target lesion revascularization (TLR) rate
- Target Lesion Failure (TLF) rate
- Target vessel revascularization (TVR) rate
- Target vessel failure (TVF) rate
- MI (Q-wave and non-Q-wave) rate
- Cardiac death rate
- Non-cardiac death rate
- All death rate
- Cardiac death or MI rate
- All death or MI rate
- All death/MI/TVR rate
- Thrombosis related to target lesion rate

Change in Quality of Life: Functional status of general health-related quality of life measured by changes in EQ-5D scores at hospital discharge, 6 months, 12 months, 24 months and 36 months.

Angiographic endpoints at 6 months post-index procedure measured by angiography (In lesion/In stent and In segment):
- Percent diameter stenosis (%DS)
- Late lumen loss
- Binary restenosis rate
- Minimum lumen diameter (MLD)

Periprocedural endpoints:
- Technical success rate
- Clinical procedural success rate

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Paclitaxel-Coated PTCA Balloon Catheter

Interventions/Control_2

SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Clinical Inclusion Criteria
1. Subject is eligible for PCI.
2. Subject has documented stable angina pectoris or unstable angina pectoris. If subject has documented stable angina pectoris, one of the following criteria meet.
- >=90% diameter stenosis.
- Stenosis that is considered a cause of stable effort angina.
- Stenosis that is confirmed a cause of functional ischemia with any test.
3. Subject is an acceptable candidate for CABG.
4. Patients undergoing first or second treatment for ISR lesions (ISR).

Angiographic Inclusion Criteria
1. The target lesion meets all following criteria.
- Target lesion length must measure (by visual estimate) <=28 mm.
- Target lesion must be a visually estimated RVD >=2.00mm and <3.00 mm(SV) / RVD >=2.00mm and <=4.00 mm(ISR).
- Target lesion must be a de novo lesion located in a native coronary artery with visually estimated stenosis >=75% and <100%.
- Coronary anatomy is likely to allow delivery of an investigational device to the lesions.
- Target lesion must be successfully pre-dilated.
2. Planned treatment of 2 coronary artery lesions in 2 vessels may be treated.

Key exclusion criteria

Clinical Exclusion Criteria
1. Subject has had an AMI within 72 hours prior to the procedure.
2. Subject has severe LVEF <30%.
3. Subject has a platelet count <100,000 cells/mm^3 or >700,000 cells/mm^3.
4. Subject has a WBC count < 3,000 cells/mm^3.
5. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
6. Subject has had a history of CVA or TIA within the past 6 months.
7. Subject has an active peptic ulcer or active GI bleeding.
8. Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure.
9. Target vessel has been treated with any type of PCI within 6 months prior to the procedure.
10. Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment.
11. Non-target vessel has been treated with any type of PCI within 24 hours prior to the procedure.
Angiographic Exclusion Criteria
1. Target lesion meets any of the following criteria:
- Left main location.
- Located within 5 mm of the origin of the LAD or LCX by visual estimate.
- >50% stenosis of an additional lesion proximal or distal to the target lesion.
- Located within a saphenous vein graft or an arterial graft.
- Will be accessed via a saphenous vein graft or an arterial graft.
- Involves a complex bifurcation.
- TIMI flow 0 prior to wire crossing.
- Excessive tortuosity proximal to or within the lesion.
- Extreme angulation proximal to or within the lesion.
- Target lesion and/or target vessel adjacent to the target lesion presents with dissection or aneurysm by visual estimate.
- Restenosis from previous intervention (SV).
- In-stent restenosis due to stent fracture or recoil (ISR).
2. Non-target lesion to be treated during the procedure meets any of the following criteria:
- Located in the target vessel (ISR).
- Located within a bypass graft
- Left main location.
- Chronic total occlusion.
- Involves a complex bifurcation.

Target sample size

180

Name of lead principal investigator

1st name	Masato
Middle name
Last name	Nakamura

Organization

Toho University Ohashi Medical Center

Division name

Division of minimally invasive treatment in cardiovascular medicine

Zip code

153-8515

Address

2-22-36, Ohashi Meguro-ku, Tokyo, Japan

TEL

03-3468-1251

Email

masato@oha.toho-u.ac.jp

Name of contact person

1st name	Sachiyo
Middle name
Last name	Sato

Organization

Boston Scientific Japan K.K.

Division name

Clinical Sciences

Zip code

164-0001

Address

4-10-2 Nakano, Nakano-ku, Tokyo, Japan

TEL

03-6853-7500

Homepage URL

Email

Sachiyo.Sato@bsci.com

Institute

Boston Scientific Japan K.K.

Institute

Department

Personal name

Organization

Boston Scientific Japan K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokushukai Group Institutional Review Board

Address

1-3-1 Kudanminami, Chiyoda-ku, Tokyo

Tel

03-3263-4801

Email

irb@mirai-iryo.com

Secondary IDs

YES

Study ID_1

NCT04058990

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

初回届出年月日: 2019年5月31日; 届出回数: 第1回

Institutions

Date of disclosure of the study information

2019

Year

08

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

180

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

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

05

Month

27

Day

Date of IRB

2019

Year

07

Month

04

Day

Anticipated trial start date

2019

Year

12

Month

12

Day

Last follow-up date

2026

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

08

Month

26

Day

Last modified on

2023

Year

08

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042932