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Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents

NCT01443104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2119

Last updated 2018-10-18

No results posted yet for this study

Summary

Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia and to reduce the rate of restenosis and target-lesion revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic platform and a therapeutic substance that is usually released from a polymer matrix. A previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and efficacy profile in a large-scale clinical trial as compared to a first-generation druf-eluting stent (LEADERS trial).

The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a prospective multicenter randomized controlled non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Conditions

Interventions

DEVICE

Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)

Percutaneous coronary intervention with implantation of a sirolimus-eluting stent with a bioresorbable polymer for coronary artery disease

DEVICE

Everolimus-eluting stent with a durable polymer

Percutaneous coronary intervention with implantation of an everolimus-eluting stent with a durable polymer for coronary artery disease

Sponsors & Collaborators

  • Biotronik AG

    collaborator INDUSTRY

  • University of Bern

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Stephan Windecker · Department of Cardiology, Bern University Hospital, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-06-30
Completion
2018-06-30

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 NCT01443104 on ClinicalTrials.gov