Leaders Free Japan

Biosensors International

Status and phase: Unknown; Phase 3

Conditions: Coronary Disease

Treatments: Drug: Dual Anti Platelet Therapy; Procedure: Percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02348021

14J01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 139 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

139 participants in 1 patient group

Drug Coated Stent

Other group

Description:

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

Treatment:

Procedure: Percutaneous coronary intervention (PCI)

Drug: Dual Anti Platelet Therapy