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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029692
Receipt No. R000033926
Scientific Title Vascular healing after the BioFreedom drug coated stent implantation: HEAL BioFreedom study
Date of disclosure of the study information 2017/10/24
Last modified on 2019/07/05

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Basic information
Public title Vascular healing after the BioFreedom drug coated stent implantation: HEAL BioFreedom study
Acronym HEAL BioFreedom study
Scientific Title Vascular healing after the BioFreedom drug coated stent implantation: HEAL BioFreedom study
Scientific Title:Acronym HEAL BioFreedom study

Condition Ischemic heart disease
Classification by specialty
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.
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
Clinically driven TLR
Not clinically driven TLR
6. Target vessel revascularization
Clinically driven TVR
Not clinically driven TVR
7. Non-target vessel revascularization
Clinically driven NTVR
Not clinically driven NTVR
8. All coronary revascularization

Study type Observational

Study design
Basic design
Randomization unit
Dynamic allocation
Institution consideration

No. of arms
Purpose of intervention
Type of intervention

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 stable angina, silent ischemia, 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

Research contact person
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

Public contact
Name of contact person
1st name Sotomi
Middle name
Last name Yohei
Organization Osaka Police Hospital
Division name Cardiology
Zip code 543-0043
Address 10-31 Kitayama Tennoji Osaka Japan 543-0035
TEL 06-6771-6051
Homepage URL

Institute Department of Cardiology, Osaka Police Hospital

Funding Source
Organization self funding
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Police Hospital
Address 10-31 Kitayama Tennoji Osaka Japan 543-0035
Tel 06-6771-6051

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2


Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2017 Year 10 Month 31 Day
Anticipated trial start date
2017 Year 10 Month 31 Day
Last follow-up date
2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information None

Management information
Registered date
2017 Year 10 Month 24 Day
Last modified on
2019 Year 07 Month 05 Day

Link to view the page

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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