Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

Summary

The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.

Conditions

• Coronary Artery Disease
• Atherosclerosis, Coronary
• Myocardial Ischemia
• Ischemic Heart Disease
• Acute Coronary Syndrome
• Angina Pectoris

Interventions

DEVICE

Orsiro DES

Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.

DEVICE

Xience DES

Sponsors & Collaborators

• Biotronik AG

  collaborator INDUSTRY

• Baim Institute for Clinical Research

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• Biotronik, Inc.

  lead INDUSTRY

Principal Investigators

• Ron Waksman, MD · Medstar Health Research Institute

• David Kandzari, MD · Piedmont Heart Institute

• Jacques Koolen, MD · Catharina Ziekenhuis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2017-04-30

Completion

2021-03-31

Countries

• United States
• Australia
• Belgium
• Canada
• Denmark
• Germany
• Hungary
• Israel
• Netherlands
• New Zealand
• South Korea
• Spain
• Switzerland

Study Locations