Overview

This trial is active, not recruiting.

Condition coronary disease
Treatments percutaneous coronary intervention (pci), dual anti platelet therapy
Phase phase 3
Sponsor Biosensors Europe SA
Collaborator Biosensors Japan Co. Ltd.
Start date July 2014
End date April 2016
Trial size 139 participants
Trial identifier NCT02348021, 14J01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
All patients in the one arm will be treated by PCI with the Drug Coated Stent.
percutaneous coronary intervention (pci)
dual anti platelet therapy
All patients will receive Dual Anti Platelet Therapy for one month

Primary Outcomes

Measure
The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
time frame: 1 year
The number of patients that experienced a clinically driven target lesion revascularization
time frame: 1 year

Secondary Outcomes

Measure
The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis
time frame: 2 years
The number of patients that experienced a clinically driven target lesion revascularization
time frame: 2 years
The number of patients that experienced a Bleeding per BARC criteria
time frame: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a cardiac death
time frame: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a definite/probable stent thrombosis.
time frame: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a myocardial infarction
time frame: 30, 60 and 120 days, and 12 and 24 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title BF-14J01 Drug Coated Stent (DCS) Clinical Trial
Principal investigator Shigeru Saito, MD
Description In this study all patients will receive the a Drug Coated Stent and will receive one month Dual Anti Platelet Therapy.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Biosensors Europe SA.