Sirolimus-eluting Stainless Steel Coronary Stent Prolim®
Conditions
Keywords
sirolimus, coronary stent, Prolim
Brief summary
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.
Detailed description
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.
Interventions
DEVICEProlim stent deployment
Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria.
Sponsors
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years old, * stable coronary artery disease (SCAD) or acute coronary syndrome (unstable angina - UA, non-ST elevation myocardial infarction - NSTEMI or ST-elevation myocardial infarction - STEMI) and * signed informed consent
Exclusion criteria
* inability to take dual antiplatelet therapy for 12 months, * left ventricular ejection fraction ≤ 30%, * chronic total occlusions, and * in-stent restenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE). | 12 months | consisting of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis. | 12 moths | Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis. |
| Late lumen loss (LLL) | 12 moths | The value (in mm) of LLL assessed in qualitative coronary angiography (QCA) |
| The percentage of covered struts assessed in optical coherence tomography (OCT) | 12 months | The percentage of covered struts assessed in OCT |
| The neointima volume assessed in OCT | 12 months | The neointima volume (in mm3) assessed in OCT |
| The device success rate | intraoperative | The percentage of Prolim stents successfully implanted. |
Outcome results
None listed