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

NCT04175626 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 556

Last updated 2026-02-27

Study results available
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Summary

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

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.

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Heart Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-24
Primary Completion
2022-01-12
Completion
2026-01-08
FDA Device
Yes

Countries

  • United States

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 NCT04175626 on ClinicalTrials.gov