Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that \<20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.
We will enroll patients with multiple coronary lesions, which, as is routine practice, will be treated with the new DES in 2 sessions (second one approximately 3-5 weeks after the first one). We will assess lesions by OFDI after the implantation and at the time of 3 months follow-up, when we will ask patients to undergo a coronary angiography. Patients will then have a follow-up contact at 1 year after initial implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Implantation of new drug eluting stent in coronary artery lesions
Cardiovascular Institute Paris Sud (ICPS)
Massy, France
CHU Rangueil
Toulouse, France
LMU
München, Germany
MCL
Leeuwarden, Netherlands
Erasmus
Rotterdam, Netherlands
Maasstadziekenhuis
Rotterdam, Netherlands
OFDI assessed percent stent strut coverage
Time frame: 3 months post procedure.
% stent strut coverage
Time frame: at 1 and 2 months
% stented lesions with >10% uncovered struts
Time frame: at 1, 2, 3 months
% of stented lesions with >20% uncovered stent struts
Time frame: at 1, 2, 3 months
% of acquired mal-apposed stent struts
Time frame: at 1, 2, 3 months
amount (mm³) of in-stent intimal hyperplasia
Time frame: at 1, 2, 3 months
amount (mm³)of in-segment hyperplasia
Time frame: at 1, 2, 3 months
neo-intimal thickness (µm)
Time frame: at 1, 2, 3 months
in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA)
Time frame: at 3 months
In-segment late lumen loss (mm) assessed by QCA
Time frame: at 3 months
Target Lesion revascularization (TLR)
Time frame: at 1, 3, 12 months
Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR
Time frame: at 1, 3, 12 months
Target Vessel Revascularization (TVR)
Time frame: at 1, 3, 12 months
Major Cardiac Adverse Events (MACE) defined as cardiac death, Q wave and non-Q wave Myocardial Infarction (MI) , emergent coronary artery bypass surgery, or target vessel revascularization (TVR)
Time frame: at 1, 3, 12 months
Stent thrombosis
Time frame: at 1, 3 and 12 months
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