Stents Clinical Trial
Official title:
Endothelial Stent Coverage and Neointimal Proliferation at 6 Months After Implantation of a Coronary Everolimus-Eluting Stent Compared With a Bare Metal Stent Postdilated With a Paclitaxel-Eluting Balloon: A Randomised Study Using Optical Coherence Tomography
Background:
Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late
stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific
information about time course and amount of endothelial strut coverage of different DES is
required, in order to further refine the concept of antiplatelet therapy after DES
implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for
endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and
neointimal proliferation. Very limited OCT data about endothelial coverage of DES are
currently available. Aim of this study is a comparative evaluation of XIENCE V® everolimus
eluting stent (Abbot Vascular) and of the bare metal stent (BMS) Coroflex® Blue postdilated
with the drug-eluting balloon (DEB) SeQuent® Please (paclitaxel-eluting balloon, B. Braun
Melsungen AG) in terms of endothelial coverage and neointimal proliferation using OCT.
Study Design:
A number of 80 patients scheduled for elective percutaneous coronary intervention (PCI) with
a native coronary stenosis suitable for DES implantation and OCT imaging are openly
randomized 1:1 to either XIENCE V® or Coroflex® Blue/Sequent® Please. The study is
prospectively conducted at a university high-volume PCI center with OCT expertise (Jena,
Germany). Angiographic follow-up and OCT imaging with motorized pull-back at 1 mm/s are
planned in all patients 6 months after implantation of the study stents. OCT endpoints are:
(1) endothelial coverage, expressed as % of struts without coverage and % of stent length
containing non-covered struts, and respectively (2) neointimal proliferation, given as %
neointimal volumetric proliferation within the whole stent and also as focal peak %
neointimal area proliferation. The study is not powered for clinical endpoints, which are:
subacute or late stent thrombosis and need for revascularization of the stent segment. Given
the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints
are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up
to 20%.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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