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Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation

NCT02486315 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 326

Last updated 2024-03-05

No results posted yet for this study

Summary

The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System; Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to cover the lesion at the level of the carina. Although deemed ideal for lesions involving only the proximal MV (1,0,0 according to Medina classification ref), this device may be used also in more complex bifurcation lesions when additional DES are required in the distal MV and/or in the SB. In the present registry the investigators report the performance and the efficacy of the self-expanding biolimus-eluting AxxessTM stent for the treatment of bifurcation lesions in a real-world population.

Conditions

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 & Collaborators

  • Clinica Mediterranea

    lead OTHER

Principal Investigators

  • Carlo Briguori, MD,PhD · Clinica Mediterranea

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-08-31
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486315 on ClinicalTrials.gov