Leaders Free Japan

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Disease
• Intervention / Treatment: Procedure: Percutaneous coronary intervention (PCI); Drug: Dual Anti Platelet Therapy

Detailed Description

In this study all patients will receive the a Drug Coated Stent and will receive one month Dual Anti Platelet Therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 139
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Kanagawa
    • Kamakura city, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Drug Coated Stent; All patients in the one arm will be treated by PCI with the Drug Coated Stent.	Procedure: Percutaneous coronary intervention (PCI); Drug: Dual Anti Platelet Therapy; All patients will receive Dual Anti Platelet Therapy for one month

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Collaborators: Biosensors Japan Co. Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 28, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: 14J01