CompletedNot Applicable

Leaders Free III: BioFreedom™ Clinical Trial

France, Switzerland404 participantsStarted 2017-11-08

Plain-language 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

Who can participate

Age range75 Years

SexALL

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Inclusion criteria

✓. Adjunctive oral anticoagulation treatment planned to continue after PCI
✓. Age ≥ 75 years old
✓. Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial)
✓. Any prior intracerebral bleed
✓. Any stroke in the last 12 months
✓. Hospital admission for bleeding during the prior 12 months
✓. Non skin cancer diagnosed or treated ≤ 3 years
✓. Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI

Exclusion criteria

✕. Pregnant and breastfeeding women
✕. Patients expected not to comply with 1 month DAPT
✕. Patients requiring a planned staged PCI procedure more than one week after the index procedure
✕. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
✕. Active bleeding at the time of inclusion
✕. If patient requires a stent \<2.5mm
✕. If patient requires a stent \>3.5mm
✕. Cardiogenic shock

What they're measuring

MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)

Timeframe: at 1 year

clinically driven target lesion revascularization (efficacy)

Timeframe: at 1 year

Trial details

NCT IDNCT03118895

SponsorBiosensors Europe SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-05

View on ClinicalTrials.gov More Cardiac Death trials