The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.
Investigators prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome, treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15% of patients (randomly chosen) underwent optical coherence tomography analysis. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization after 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria.
The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).
consisting of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR)
Time frame: 12 months
Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.
Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.
Time frame: 12 moths
Late lumen loss (LLL)
The value (in mm) of LLL assessed in qualitative coronary angiography (QCA)
Time frame: 12 moths
The percentage of covered struts assessed in optical coherence tomography (OCT)
The percentage of covered struts assessed in OCT
Time frame: 12 months
The neointima volume assessed in OCT
The neointima volume (in mm3) assessed in OCT
Time frame: 12 months
The device success rate
The percentage of Prolim stents successfully implanted.
Time frame: intraoperative
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