Clinical trial NCT02348021: Leaders Free Japan
Official title: BF-14J01 Drug Coated Stent (DCS) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Disease
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: Biosensors Japan Co. Ltd.
First posted: 2015-01-28
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
timeFrame: 1 year
measure: The number of patients that experienced a clinically driven target lesion revascularization
timeFrame: 1 year
Secondary outcomes:
measure: The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis
timeFrame: 2 years
measure: The number of patients that experienced a clinically driven target lesion revascularization
timeFrame: 2 years
measure: The number of patients that experienced a Bleeding per BARC criteria
timeFrame: 30, 60 and 120 days, and 12 and 24 months
measure: The number of patients that experienced a cardiac death
timeFrame: 30, 60 and 120 days, and 12 and 24 months
measure: The number of patients that experienced a definite/probable stent thrombosis.
timeFrame: 30, 60 and 120 days, and 12 and 24 months
measure: The number of patients that experienced a myocardial infarction
timeFrame: 30, 60 and 120 days, and 12 and 24 months
Other outcomes:
Locations:
city: Kamakura city
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
Study officials:
affiliation: Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References: