Novel Sirolimus-eluting Stent Prolim® With a Biodegradable Polymer in the All-comers Population
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sirolimus-eluting Stainless Steel Coronary Stent Prolim®
- Sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
- Enrollment
- 204
- Primary Endpoint
- The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Jacek Bil
MD, PhD
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Eligibility Criteria
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
Outcomes
Primary Outcomes
The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).
Time Frame: 12 months
consisting of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR)
Secondary Outcomes
- The percentage of covered struts assessed in optical coherence tomography (OCT)(12 months)
- The neointima volume assessed in OCT(12 months)
- Late lumen loss (LLL)(12 moths)
- Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.(12 moths)
- The device success rate(intraoperative)