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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034769
Receipt No. R000039653
Official scientific title of the study Vascular healing after the BioFreedom drug coated stent implantation in patients with acute coronary syndrome: HEAL-BioFreedom ACS study
Date of disclosure of the study information 2018/11/05
Last modified on 2018/11/05

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Basic information
Official scientific title of the study Vascular healing after the BioFreedom drug coated stent implantation in patients with acute coronary syndrome: HEAL-BioFreedom ACS study
Title of the study (Brief title) HEAL-BioFreedom ACS study
Region
Japan

Condition
Condition Acute coronary syndrome
Classification by specialty
Cardiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator Yoshiharu Higuchi
Organization Osaka Police Hospital
Division name Cardiology
Address 10-31 Kitayama Tennoji Osaka Japan 543-0035
TEL 06-6771-6051
Email yhiguchi-ja@oph.gr.jp

Public contact
Name of contact person Yohei Sotomi
Organization Osaka Police Hospital
Division name Cardiology
Address 10-31 Kitayama Tennoji Osaka Japan 543-0035
TEL 06-6771-6051
Homepage URL
Email sotomiyohei@gmail.com

Sponsor
Institute Department of Cardiology, Osaka Police Hospital
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 05 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information None

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039653

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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