Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation

CompletedOBSERVATIONAL
Enrollment

326

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

June 30, 2015

Conditions
Coronary Artery Disease
Interventions
DEVICE

AXXESS stent

Axxess stent is a conically-shaped, self-expanding nitinol stent, with a 0.006-inch strut thickness, specifically designed to preserve and to match the anatomy of the bifurcation at the carina level. The stent is coated with Biolimus A9™, a highly lipophilic, semi-synthetic sirolimus analogue, immersed in the biodegradable polylactic acid (PLA) applied primarily to the abluminal surface. PLA completely dissolves after 6 to 9 months.The stent has 3 radiopaque markers at the distal end and one at the proximal end to aid in the visibility and placement. The AxxessTM stent is 7 Fr guiding catheter or Sheathless Guiding Catheter compatible. During the study period, the AxxessTM stent was available in 3 different diameters (3.0, 3.5 and 4.0 mm) and lengths (9, 10 and 14 mm)

Sponsors
All Listed Sponsors
lead

Clinica Mediterranea

OTHER

NCT02486315 - Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation | Biotech Hunter | Biotech Hunter