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

Not Applicable

Completed

• Conditions: Sirolimus-eluting Stainless Steel Coronary Stent Prolim®
• Interventions: Device: Prolim stent deployment

• Registration Number: NCT02545985
• Lead Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Study First Submitted: 2015-08-30
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Last Update Submitted: 2015-09-12
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prolim stent implantation	Prolim stent deployment	In patients with symptomatic coronary artery disease Prolim stent was implanted in coronary arteries

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Late lumen loss (LLL)	12 moths	The value (in mm) of LLL assessed in qualitative coronary angiography (QCA)
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.
The device success rate	intraoperative	The percentage of Prolim stents successfully implanted.