UMIN-CTR Clinical Trial

Public title

Vascular healing after the BioFreedom drug coated stent implantation in patients with acute coronary syndrome: HEAL-BioFreedom ACS study

Acronym

HEAL-BioFreedom ACS study

Scientific Title

Vascular healing after the BioFreedom drug coated stent implantation in patients with acute coronary syndrome: HEAL-BioFreedom ACS study

Scientific Title:Acronym

HEAL-BioFreedom ACS study

Region

Japan

Condition

Acute coronary syndrome

Classification by specialty

Cardiology

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of the present study is to evaluate the neointimal healing of the DCS at early phase (3 months) with optical coherence tomography and coronary angioscopy in patients with acute coronary syndrome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Healing Score at 3 months follow-up

Key secondary outcomes

OCT Endpoints (3 months)
1. All individual components of the Healing Score at 3 months;
2. Mean/minimal scaffold/stent diameter/area/volume at 3 months;
3. Mean/minimal lumen diameter/area/volume at 3 months;
4. Incomplete strut apposition (ISA) area/volume at 3 months;
5. Percentage of covered struts at 3 months;
6. Mean/maximal thickness of the struts coverage at 3 months;
7. Neointimal hyperplasia area/volume at 3 months;
8. Mean Flow area/volume at 3 months;
9. Intraluminal defect area/ volume at 3 months;
10. Thickness of neointimal tissue at 3 months.

Angioscopy Endpoint (3months)
Maximum and minimum neointima coverage grade, maximum yellow color grade, and presence or absence of thrombus was determined for each stented lesion.

Clinical endpoints: (at discharge, 3 months and 12 months)
1. Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target vessel revascularization, and its individual components
2. Death
All-cause death
Cardiac death
Non-cardiac death
3. Myocardial infarction according to the Third universal definition
Q wave Myocardial Infarction
Non-Q wave Myocardial Infarction
All Myocardial Infarction
4. Stent Thrombosis per ARC definition7
Definite, Probable and Possible
5. Target lesion revascularization
All TLR
Clinically driven TLR
Not clinically driven TLR
6. Target vessel revascularization
All TVR
Clinically driven TVR
Not clinically driven TVR
7. Non-target vessel revascularization
All NTVR
Clinically driven NTVR
Not clinically driven NTVR
8. All coronary revascularization

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Any indication for PCI in patients presenting as ACS (STEMI and non-STEMI), with de novo target lesions, deemed at high risk for bleeding and candidates for 1 month DAPT, satisfying at least one on the following criteria:

1. Adjunctive oral anticoagulation treatment planned to continue after PCI
2. Age equal to or more than 75 years old
3. Baseline Hemoglobin less than 11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization)
4. Any prior intra-cerebral bleed
5. Any stroke in the last 12 months
6. Hospital admission for bleeding during the prior 12 months
7. Non skin cancer diagnosed or treated less than 3 years
8. Planned daily NSAID (other than aspirin) or steroids for more than 30 days after PCI
9. Planned surgery that would require interruption of DAPT (within next 12 months)
10. Renal failure defined as calculated creatinine clearance less than 40 ml/min
11. Thrombocytopenia (PLT less than 100,000/mm3)
12. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
13. Expected non-compliance to prolonged DAPT for other medical reasons

Key exclusion criteria

1. Pregnant and breastfeeding women
2. Patients expected not to comply with 1 month DAPT
3. Patients requiring a planned staged PCI procedure more than two weeks after the index procedure
4. Procedure planned to require non-study stents, or stand-alone POBA or stand-alone atherectomy
5. Active bleeding at the time of inclusion
6. Reference vessel diameter less than 2.25 or more than 4.0mm
7. Cardiogenic shock
8. Compliance with long-term single anti-platelet therapy unlikely
9. Known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, umirolimus (also known as biolimus A9) or a sensitivity to contrast media, which cannot be adequately pre-medicated
10. PCI during the previous 6 months for a stable lesion other than the target lesion of the index procedure
OR PCI during the previous 12 months for a ACS lesion other than the target lesion of the index procedure
11. Participation in another clinical trial (up to 12 months after index procedure)
12. Patients with a life expectancy of less than 1 year

Target sample size

30

Name of lead principal investigator

1st name	Yoshiharu
Middle name
Last name	Higuchi

Organization

Osaka Police Hospital

Division name

Cardiology

Zip code

543-0035

Address

10-31 Kitayama Tennoji Osaka Japan 543-0035

TEL

06-6771-6051

Email

yhiguchi-ja@oph.gr.jp

Name of contact person

1st name	Yohei
Middle name
Last name	Sotomi

Organization

Osaka Police Hospital

Division name

Cardiology

Zip code

543-0035

Address

10-31 Kitayama Tennoji Osaka Japan 543-0035

TEL

06-6771-6051

Homepage URL

Email

sotomiyohei@gmail.com

Institute

Department of Cardiology, Osaka Police Hospital

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IRB, Osaka Police Hospital

Address

10-31 Kitayama Tennoji Osaka Japan 543-0035

Tel

06-6771-6051

Email

yhiguchi-ja@oph.gr.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

10

Month

01

Day

Date of IRB

2017

Year

11

Month

10

Day

Anticipated trial start date

2018

Year

10

Month

01

Day

Last follow-up date

2023

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

None

Registered date

2018

Year

11

Month

05

Day

Last modified on

2023

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039653