True Coronary Bifurcation Lesions Clinical Trial
Official title:
Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With a Dedicated Bifurcation Device (Axxess™ Drug Eluting Coronary Bifurcation Stent System + Biomatrix™ Drug Eluting Coronary Stent System Stents in the Distal Branches) Versus the Culotte Technique Using Xience Prime Everolimus-eluting Stents : an Optical Coherence Tomography (OCT) Analysis
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.
BACKGROUND: There is an ongoing controversy over the efficacy and safety of different
bifurcation stenting techniques. Critical considerations are the rate of restenosis at the
side branch ostium, and completeness of healing at sites of overlap of stent struts, which
may affect the risk of stent thrombosis.
AIMS: To compare vessel healing at 9 months using OCT imaging for two different treatment
techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be
used to assess re-endothelialisation and quality of strut apposition to the vessel wall.
METHODS: Patients with true bifurcation lesions with involvement of a significant side
branch requiring a stent will be randomly assigned to one of two treatment strategies. Group
A will comprise 20 patients which will be treated with the Axxess™ Drug Eluting Coronary
Bifurcation Stent System (Biosensors Europe SA) where additional Biomatrix™ Drug Eluting
Coronary Stent Systems (Biosensors Europe SA) are implanted into the distal main branch (MB)
and the side branch (SB) as required. Group B will consist of 20 patients which will be
treated with the culotte technique using Xience Prime everolimus-eluting stents
(Abbott-Vascular, US). Kissing balloon dilatation using non-compliant balloons will complete
the index procedure in all cases. At 9 months, control angiography for all patients (with
QCA using dedicated software) and OCT (of both main vessel and side branch) will be
performed.
ENROLMENT PLAN:
Start: Third quarter of 2011 Enrolment period: ± 12 months Clinical follow-up: 5 years
Angiographic and OCT results expected third quarter of 2013
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