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Leaders Free Japan

Primary Purpose

Coronary Disease

Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Percutaneous coronary intervention (PCI)
Dual Anti Platelet Therapy
Sponsored by
Biosensors Europe SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:

  1. Adjunctive oral anticoagulation treatment planned to continue after PCI
  2. Age ≥ 75 years old
  3. Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to enrollment)
  4. Any prior intracerebral 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 < 3 years
  8. Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI
  9. Planned surgery that would require interruption of DAPT (within next 12 months)
  10. Renal failure defined as: Creatinine clearance <40 ml/min
  11. Thrombocytopenia (PLT <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

Exclusion Criteria:

  1. Pregnant and breastfeeding women
  2. Patients expected not to comply with 30 days DAPT
  3. Patients requiring a planned staged PCI procedure more than one week 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 <2.25 ~ >4.0mm
  7. Cardiogenic shock
  8. Compliance with long-term single anti-platelet therapy unlikely
  9. A known hypersensitivity or contraindication to aspirin, clopidogrel or other P2Y12 inhibitor (if applicable), stainless steel, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
  10. PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
  11. Participation in another clinical trial (12 months after index procedure)
  12. Patients with a life expectancy of < 1 year

Sites / Locations

  • Shonan Kamakura General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Drug Coated Stent

Arm Description

All patients in the one arm will be treated by PCI with the Drug Coated Stent.

Outcomes

Primary Outcome Measures

The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
The number of patients that experienced a clinically driven target lesion revascularization

Secondary Outcome Measures

The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis
The number of patients that experienced a clinically driven target lesion revascularization
The number of patients that experienced a Bleeding per BARC criteria
The number of patients that experienced a cardiac death
The number of patients that experienced a definite/probable stent thrombosis.
The number of patients that experienced a myocardial infarction

Full Information

First Posted
September 11, 2014
Last Updated
September 28, 2015
Sponsor
Biosensors Europe SA
Collaborators
Biosensors Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02348021
Brief Title
Leaders Free Japan
Official Title
BF-14J01 Drug Coated Stent (DCS) Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosensors Europe SA
Collaborators
Biosensors Japan Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.
Detailed Description
In this study all patients will receive the a Drug Coated Stent and will receive one month Dual Anti Platelet Therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug Coated Stent
Arm Type
Other
Arm Description
All patients in the one arm will be treated by PCI with the Drug Coated Stent.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention (PCI)
Intervention Type
Drug
Intervention Name(s)
Dual Anti Platelet Therapy
Intervention Description
All patients will receive Dual Anti Platelet Therapy for one month
Primary Outcome Measure Information:
Title
The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
Time Frame
1 year
Title
The number of patients that experienced a clinically driven target lesion revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis
Time Frame
2 years
Title
The number of patients that experienced a clinically driven target lesion revascularization
Time Frame
2 years
Title
The number of patients that experienced a Bleeding per BARC criteria
Time Frame
30, 60 and 120 days, and 12 and 24 months
Title
The number of patients that experienced a cardiac death
Time Frame
30, 60 and 120 days, and 12 and 24 months
Title
The number of patients that experienced a definite/probable stent thrombosis.
Time Frame
30, 60 and 120 days, and 12 and 24 months
Title
The number of patients that experienced a myocardial infarction
Time Frame
30, 60 and 120 days, and 12 and 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent. Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following: Adjunctive oral anticoagulation treatment planned to continue after PCI Age ≥ 75 years old Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to enrollment) Any prior intracerebral bleed Any stroke in the last 12 months Hospital admission for bleeding during the prior 12 months Non skin cancer diagnosed or treated < 3 years Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI Planned surgery that would require interruption of DAPT (within next 12 months) Renal failure defined as: Creatinine clearance <40 ml/min Thrombocytopenia (PLT <100,000/mm3) Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice Expected non-compliance to prolonged DAPT for other medical reasons Exclusion Criteria: Pregnant and breastfeeding women Patients expected not to comply with 30 days DAPT Patients requiring a planned staged PCI procedure more than one week after the index procedure Procedure planned to require non-study stents, or stand-alone POBA or stand-alone atherectomy Active bleeding at the time of inclusion Reference vessel diameter <2.25 ~ >4.0mm Cardiogenic shock Compliance with long-term single anti-platelet therapy unlikely A known hypersensitivity or contraindication to aspirin, clopidogrel or other P2Y12 inhibitor (if applicable), stainless steel, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated PCI during the previous 12 months for a lesion other than the target lesion of the index procedure Participation in another clinical trial (12 months after index procedure) Patients with a life expectancy of < 1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
Shonan Kamakura General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shonan Kamakura General Hospital
City
Kamakura city
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Leaders Free Japan

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