NCT02545985

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sirolimus-eluting Stainless Steel Coronary Stent Prolim®

Interventions

Type	Name	Description
DEVICE	Prolim stent deployment	Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-03-01
• Completion: 2015-06-01
• First posted: 2015-09-10
• Last updated: 2015-09-15