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.

Trial   N Planned FU Status Comparator
STEALTH PK   27 1 yr Completed Single Arm
STEALTH I   120 5 yrs Completed Gazelle™ (BMS)
BEACON I   292 1 yr Completed Single Arm
LEADERS   1707 5 yrs 4 yrs FU completed Cypher® Select™ (DES)
BEACON II   497 5 yrs 2 yrs FU completed Single Arm
e-BioMatrix PMS 1000 5 yrs PMS 1 yr FU completed
PMR Currently enrolling		 Single Arm
PMR 4000
e-BioMatrix
INDIA

PMD

 1000 5 yrs Currently enrolling Single Arm
PMR 4000
e-BioMatrix FRANCE   1500 2 yrs FU Currently enrolling Single Arm

 

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% TVR at 6 months

LEADERS N = 1707


Design: Randomized, Multicenter All-Comers Clinical Trial.

BioMatrix Flex™ vs. Cypher® Select™

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

MACE defined as Cardiac Death, Ischemic Driven MI

(Q-wave and NQ-wave) and Ischemic Driven TLR (PTCA and CABG)

Primary endpoint: MACE at 12 months

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

Results: 5.6% MACE at 6 months.

e-BioMatrix N= +5000


Design: Multicenter Single Arm Post Market Registry

PMS: n =1000 - 100% monitoring

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

MACE defined as Cardiac Death, MI (Q-wave and NQ-wave), or clinically-indicated TVR

Primary endpoint: MACE at 12 months.

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

e-BioMatrix India N= 5000


Design: Multicenter Single Arm Post Market Registry

PMD: n=1000 - 100% monitoring

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

MACE defined as Cardiac Death, MI (Q-wave and NQ-wave), or clinically-indicated TVR

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.