Leaders Free Japan

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02348021
• Other study ID #: 14J01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 11, 2014
• Last updated: September 28, 2015
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: September 2015
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 139
• Est. completion date: July 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Procedure:
• Percutaneous coronary intervention (PCI)

Drug:
• Dual Anti Platelet Therapy
All patients will receive Dual Anti Platelet Therapy for one month

Locations

Country	Name	City	State
Japan	Shonan Kamakura General Hospital	Kamakura city	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Biosensors Europe SA	Biosensors Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.		1 year	Yes
Primary	The number of patients that experienced a clinically driven target lesion revascularization		1 year	No
Secondary	The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis		2 years	No
Secondary	The number of patients that experienced a clinically driven target lesion revascularization		2 years	No
Secondary	The number of patients that experienced a Bleeding per BARC criteria		30, 60 and 120 days, and 12 and 24 months	No
Secondary	The number of patients that experienced a cardiac death		30, 60 and 120 days, and 12 and 24 months	No
Secondary	The number of patients that experienced a definite/probable stent thrombosis.		30, 60 and 120 days, and 12 and 24 months	No
Secondary	The number of patients that experienced a myocardial infarction		30, 60 and 120 days, and 12 and 24 months	No