Leaders Free Japan

NCT ID: NCT02348021

Last Updated: 2015-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-07-31

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.

Conditions

Coronary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug Coated Stent

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

Group Type: OTHER

Percutaneous coronary intervention (PCI)

Intervention Type: PROCEDURE

Dual Anti Platelet Therapy

Intervention Type: DRUG

All patients will receive Dual Anti Platelet Therapy for one month

Interventions

Percutaneous coronary intervention (PCI)

Intervention Type: PROCEDURE

Dual Anti Platelet Therapy

All patients will receive Dual Anti Platelet Therapy for one month

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosensors Japan Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

Biosensors Europe SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Shonan Kamakura General Hospital

Locations

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Countries

Japan

Other Identifiers

14J01

Identifier Type: -

Identifier Source: org_study_id