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

NCT04175626 | Completed Results FDA Device

• 1 other identifier: BIOFLOW-VII
• Study Type: observational
• Target: 556
• Locations: 1 country
• Sites: 33

Brief 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

Keywords

Drug eluting coronary stents; Sirolimus; Bioabsorbable polymer; DES

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure

  TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).

  12-Months

Secondary Outcomes (12)

• All-cause Death

  at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year

• Protocol-defined Any-vessel Myocardial Infarction

  at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year

• Target Lesion Revascularization (TLR)

  at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year

• Target Vessel Revascularization (TVR)

  at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year

• Cardiac Death or Protocol-defined Any-vessel MI

  at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year

Study Arms (1)

Orsiro sirolimus coronary stent system

Intervention with a Orsiro DES.

Device: Orsiro DES

Interventions

Orsiro DES DEVICE

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.

Also known as: Orsiro sirolimus coronary stent system

Orsiro sirolimus coronary stent system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with coronary artery disease (CAD), including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ≤ 36 mm.

You may qualify if:

• Subject is ≥18 years of age.
• Subject was an acceptable candidate for treatment with a drug eluting stent at the qualifying index procedure, in accordance with the applicable guidelines on percutaneous coronary interventions and manufacturer's Instructions for Use.
• Subject received at least one Orsiro stent during an index procedure occurring within 24 hours prior to informed consent, as assessed by the end time of procedure. If more than one stent was implanted during the index procedure, all stents were Orsiro stents.
• Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.
• Subject is willing to comply with study follow-up requirements.
• Subject has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. Legally authorized representatives are not allowed to consent on a subject's behalf.
• Each target lesion/vessel must have met all of the following angiographic criteria from the index procedure for the subject to be eligible for the trial:
• Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel).
• Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
• Target lesion must be in major coronary artery or branch (target vessel).
• Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate). If the target lesion is \< 70% stenosed, there should be clinical evidence of ischemia.
• Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \> 1.
• Target lesion must be ≤ 36 mm in length by operator visual estimate.
• Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
• Target lesion must have been treated with a maximum of two overlapping stents.

You may not qualify if:

• Subject had clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure.
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
• Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), silicon carbide, PLLA, sirolimus.
• Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure or any PCI planned within the next 1 year.
• Presence of an untreated clinically significant stenosis post-procedure whether treatment is planned or not.
• Planned surgery within 6 months of index procedure unless DAPT can be maintained throughout the peri-surgical period.
• History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
• Subject has documented LVEF \< 30% prior to consent.
• Subject is dialysis-dependent.
• Subject has impaired renal function (blood creatinine \> 2.5 mg/dL or 221 μmol/L prior to the index procedure).
• Subject has leukopenia (i.e. \< 3,000 white blood cells/mm3), thrombocytopenia (i.e. \< 100,000 platelets/mm3) or thrombocytosis (i.e. \> 700,000 platelet/mm3).
• Any significant concurrent medical diagnosis that would potentially impact DAPT effectiveness or increase thrombotic risk.
• Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
• Subject has life expectancy of \< 1 year.
• Subject is participating in an investigational (medical device or drug) clinical study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the follow-up requirements of this study or does not involve a drug that may confound the interpretation of any relevant clinical events of interest (e.g. investigational DAPT therapy).

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (33)

Cardiology Associates of Mobile

Fairhope, Alabama, 36532, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

St. Joseph Hospital Orange

Orange, California, 92868, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Ascension St. Vincent Medical Group

Indianapolis, Indiana, 46920, United States

Location

Ascension Via Christi Hospitals

Wichita, Kansas, 67226, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Northern Light Cardiology

Bangor, Maine, 04401, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Mercy Health - St Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Penn State Health Holy Spirit Medical Center

Camp Hill, Pennsylvania, 17011, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

UT Health Science Center

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Charleston Area Medical Center Memorial Hospital

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Crystal Miller
• Organization: Biotronik, Inc

crystal.miller@biotronik.com

1 800-547-0394

Study Officials

• David Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: January 24, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 8, 2026
• Last Updated: February 27, 2026
• Results First Posted: April 26, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning no later than 12 months and ending no earlier than 3 years following initial publication of clinical study results.
• Access Criteria: Researchers who provide a methodologically sound proposal for analysis that is not pre-planned or already approved with another researcher. Proposals must be approved by BIOTRONIK and Study Principal Investigator. Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR 97035; 1-800-547-0394). To gain access, data requesters will need to sign a data use/access agreement.

Locations

US (33)