First-in-man Sirolimus-eluting Prolim® Stent Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Sirolimus-eluting Stent Prolim® With a Biodegradable Polymer in the All-comers Population

Conditions
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Sirolimus-eluting Stainless Steel Coronary Stent Prolim®

Intervention / Treatment
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* Device: Prolim stent deployment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolim stent implantation<br>In patients with symptomatic coronary artery disease Prolim stent was implanted in coronary arteries | Device: Prolim stent deployment<br>* Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 moths | 
| Late lumen loss (LLL) | The value (in mm) of LLL assessed in qualitative coronary angiography (QCA) | 12 moths | 
| The percentage of covered struts assessed in optical coherence tomography (OCT) | The percentage of covered struts assessed in OCT | 12 months | 
| The neointima volume assessed in OCT | The neointima volume (in mm3) assessed in OCT | 12 months | 
| The device success rate | The percentage of Prolim stents successfully implanted. | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sirolimus, coronary stent, Prolim