Bleeding, Cardiac Death, Mortality, Myocardial Infarction, Stent Thrombosis
Conditions
Brief summary
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
Detailed description
Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.
Interventions
Drug-coated stent for coronary arteries
Sponsors
European Cardiovascular Research Center
Biosensors Europe SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
370 high bleeding risk items
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of 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 inclusion into the trial) 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 1 month DAPT 3. Patients requiring a planned staged PCI procedure more than one week after the index procedure 4. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only). 5. Active bleeding at the time of inclusion 6. If patient requires a stent \<2.5mm 7. If patient requires a stent \>3.5mm 8. Cardiogenic shock 9. Compliance with long-term single anti-platelet therapy unlikely 10. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated 11. PCI during the previous 12 months for a lesion other than the target lesion 12. Participation in another clinical trial (12 months after index procedure) 13. Patients with a life expectancy of \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) | at 1 year | Incidence |
| clinically driven target lesion revascularization (efficacy) | at 1 year | incidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Driven Target Vessel Revascularization | At 1 and 4 months, and 2 years | Incidence |
| All-cause mortality | At 1 and 4 months, and 1 and 2 years | incidence |
| Clinically Driven Target Lesion Revascularization | At 1 and 4 months, and 2 years | Incidence |
Countries
France, Switzerland
Outcome results
None listed