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COmplex BifuRcation Lesions: a Comparison Between the AXXESS Device and Culotte Stenting: an Optical Coherence Tomography (OCT) Study

NCT01486095 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-09

No results posted yet for this study

Summary

Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double stent technique is used) is associated with a higher risk for stent thrombosis. Different factors may play a role in the higher risk for stent thrombosis in bifurcation lesions. Possible mechanisms are delayed endothelialisation due to the action of the drug, coating polymers, or overlapping stent segments, incomplete stent apposition at specific sites in the bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation site. In human pathological data, the RUTSS (ratio of uncovered to total stent struts) appears to be the most powerful predictor of stent thrombosis.

This prospective study will assess the differences in stent strut coverage and stent strut apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus A9-eluting stents in the distal main vessel and the side branch versus treatment with the culotte technique using the Xience Prime everolimus-eluting stents.

Conditions

  • True Coronary Bifurcation Lesions

Interventions

DEVICE

AXXESS + Biomatrix Biolimus Eluting stent

NAP

DEVICE

Culotte technique with Xience V or Xience Prime stents

NAP

Sponsors & Collaborators

  • Biosensors International

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Christophe L Dubois, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-29
Primary Completion
2013-12-31
Completion
2017-12-31

Countries

  • Belgium

Study Locations

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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 NCT01486095 on ClinicalTrials.gov