Clinical Trials

Taking the LEAD in DES Clinical Excellence

Our trials gather clinical data for this technology from a wide range of patients, including those with single de novo lesions, multiple vessel disease, acute coronary syndromes, bifurcations, left main, small vessels and extreme long lesions.

Biosensors Clinical Trials

STEALTH PK N = 27


Design: Single arm registry, Pharmacokinetics

Primary endpoint: BA9™ concentration at 30 days and 6 months.

STEALTH I N = 120


Design: Randomized, Multicenter clinical trial - BioMatrix™ vs. Gazelle™* (2:1)

Primary endpoint: In-stent Late Loss at 6 months.

Results: 0.09 vs 0.48 mm (p < 0.01)

BEACON I N = 292


Design: Multicenter Single Arm Registry

Primary endpoint: TVR at 6 months.

Results: 2.1%

LEADERS N = 1707


Design: Randomized, Multicenter All comers Clinical Trials

Biolimus eluting stent vs. Sirolimus eluting stent

Primary endpoint: CV death, MI, clinically-indicated, TVR at 9 months

Results: 9.2% vs 10.5% (P non-inferiority = 0.003)

LEADERS OCT


Sub-group of the LEADERS trial - OCT (Optical Coherence Tomography)

BEACON II N = 497


Design: Multicenter Single Arm Post Market Registry

Primary endpoint: MACE at 12 months

Follow-up of 30 days, 90 days, 6, 12 months, 2-5 years

Enrollment completed in December 2008.

e-BioMatrix N= 5000


Design: Multicenter Single Arm Post Market Registry

PMS: N=1000 - 100% monitoring

PMR: N=4000 - 100% monitoring of adverse events

Primary endpoint: MACE at 12 months.

Follow-up of 30 days, 12 months and 2-5 years

BioFreedom N = 300


Design: Randomized 3-arm safety and effectiveness study with a follow-up of 30 days, 4 months, 12 months and 2-5 years.

Primary endpoint: In-stent late loss at 12 months.