Completed OBSERVATIONAL NCT04175626

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (BIOFLOW-VII)

BIOTRONIK - A Prospective Multicenter Study to Confirm the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - VII

Sponsor: Biotronik, Inc.

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

Interventions Orsiro DES

Updated 23 times since 2019 Last updated: Feb 8, 2026 Started: Jan 24, 2020 Primary completion: Jan 12, 2022 Completion: Jan 8, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Acute Coronary Syndrome and Angina Pectoris, this trial is completed. The trial is conducted by Biotronik, Inc. and has accumulated 23 data snapshots since 2020. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

Change History

23 versions recorded

Feb 2026 — Present [monthly]

Completed

Status: Active Not Recruiting → Completed
Sep 2025 — Feb 2026 [monthly]

Active Not Recruiting
May 2025 — Sep 2025 [monthly]

Active Not Recruiting
Sep 2024 — May 2025 [monthly]

Active Not Recruiting
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting

▶ Show 18 earlier versions

Jun 2024 — Jul 2024 [monthly]

Active Not Recruiting
May 2024 — Jun 2024 [monthly]

Active Not Recruiting
Apr 2022 — May 2024 [monthly]

Active Not Recruiting
May 2021 — Apr 2022 [monthly]

Active Not Recruiting
Mar 2021 — May 2021 [monthly]

Active Not Recruiting
Jan 2021 — Mar 2021 [monthly]

Active Not Recruiting

Status: Recruiting → Active Not Recruiting
Dec 2020 — Jan 2021 [monthly]

Recruiting
Nov 2020 — Dec 2020 [monthly]

Recruiting
Oct 2020 — Nov 2020 [monthly]

Recruiting
Sep 2020 — Oct 2020 [monthly]

Recruiting
Aug 2020 — Sep 2020 [monthly]

Recruiting
Jul 2020 — Aug 2020 [monthly]

Recruiting
Jun 2020 — Jul 2020 [monthly]

Recruiting
May 2020 — Jun 2020 [monthly]

Recruiting
Apr 2020 — May 2020 [monthly]

Recruiting
Mar 2020 — Apr 2020 [monthly]

Recruiting
Feb 2020 — Mar 2020 [monthly]

Recruiting

Status: Not Yet Recruiting → Recruiting
Dec 2019 — Feb 2020 [monthly]

Not Yet Recruiting

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Biotronik, Inc.

Data source: Biotronik, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anderson, United States , Ann Arbor, United States , Atlanta, United States , Austin, United States , Baltimore, United States , Bangor, United States , Boston, United States , Brooklyn, United States , Camp Hill, United States , Charleston, United States and 19 more locations