MedTrace Logo

A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

NCT02579031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2020-09-02

No results posted yet for this study

Summary

PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in MACE among patients with STEMI undergoing primary PCI with newer generation stents with enhanced biocompatibility.

The present trial aims at filling the current gap of evidence by providing randomized data to establish the superior clinical outcome with an ultrathin strut third-generation DES with biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing primary PCI, compared to the current state-of-the art second-generation DES with permanent polymer.

Conditions

Interventions

DEVICE

Orsiro

Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention

DEVICE

Xience

Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention

Sponsors & Collaborators

  • University of Lausanne Hospitals

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Thomas Pilgrim, Prof. Dr. med. · Dep. of Cardiology, Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-04-30
Completion
2020-05-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579031 on ClinicalTrials.gov