Trials / Completed
CompletedNCT04175626
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 556 (actual)
- Sponsor
- Biotronik, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
BIOFLOW-VII is a prospective, multicenter, single-arm study. Subjects with coronary artery disease (CAD) who undergo an on-label percutaneous coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened post-index procedure per the protocol inclusion and exclusion criteria. Following the index procedure and study enrollment, subjects will be followed for 5 years. The follow-up schedule will include an intermediate study visit at 1 month, a primary endpoint study visit at 12 months, and long-term study visits at 2, 3, 4, and 5 years.
Conditions
- Coronary Artery Disease
- Atherosclerosis, Coronary
- Myocardial Ischemia
- Ischemic Heart Disease
- Acute Coronary Syndrome
- Angina Pectoris
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-01-24
- Primary completion
- 2022-01-12
- Completion
- 2026-01-08
- First posted
- 2019-11-25
- Last updated
- 2026-02-27
- Results posted
- 2024-04-26
Locations
33 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04175626. Inclusion in this directory is not an endorsement.