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

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Status: Completed

Conditions: Sirolimus-eluting Stainless Steel Coronary Stent Prolim®

Treatments: Device: Prolim stent deployment

Study type: Interventional

Funder types: Other

Identifiers

NCT02545985

1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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204 participants in 1 patient group

Prolim stent implantation

Experimental group

Description:

In patients with symptomatic coronary artery disease Prolim stent was implanted in coronary arteries

Treatment:

Device: Prolim stent deployment