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Clinical Trials/NCT02348021
NCT02348021UnknownPhase 3

BF-14J01 Drug Coated Stent (DCS) Clinical Trial

Biosensors Europe SA1 site in 1 country139 target enrollmentStarted: July 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
139
Locations
1
Primary Endpoint
The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Drug Coated Stent

Other

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

Intervention: Percutaneous coronary intervention (PCI) (Procedure)

Drug Coated Stent

Other

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

Intervention: Dual Anti Platelet Therapy (Drug)

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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