Coronary Artery DiseaseBIOFLOW-VIINCT04175626
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
An observational study of Coronary Artery Disease and Atherosclerosis, Coronary, run by Biotronik, Inc. at 33 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia
- What is being tested?
- Orsiro DES
- Type of treatment
- Medical device
- How many people
- 556 participants
- Where
- 33 sitesUnited States
- Study dates
- 24 Jan 2020to 8 Jan 2026
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
- Subjects will be excluded from the trial if any of the target lesions/vessels met any of the following angiographic criteria during the index procedure:
- Target lesion was located within or treated through a saphenous vein graft or arterial graft.
- Target lesion was a restenotic lesion that was previously treated with a bare metal or drug-eluting stent (in-stent restenosis).
- Target lesion had any of the following characteristics:
- Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
- Involves a side branch of > 2.0 mm in diameter.
- Target vessel/lesion was excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
- Target vessel had angiographic evidence of thrombus.
- Target lesion was totally occluded (100% stenosis).
- Target vessel was treated with brachytherapy any time prior to the index procedure.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
AnMed Health
Anderson, South Carolina, 29621
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Atlanta, Georgia, 30309
Seton Medical Center Austin
Austin, Texas, 78705
Austin Heart
Austin, Texas, 78756
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Northern Light Cardiology
Bangor, Maine, 04401
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Maimonides Medical Center
Brooklyn, New York, 11219
Penn State Health Holy Spirit Medical Center
Camp Hill, Pennsylvania, 17011
Charleston Area Medical Center Memorial Hospital
Charleston, West Virginia, 25304
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Illinois
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
John Muir Medical Center
Concord, California, 94520
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226
Cardiology Associates of Mobile
Fairhope, Alabama, 36532
UT Health Science Center
Houston, Texas, 77030
Ascension St. Vincent Medical Group
Indianapolis, Indiana, 46920
University of Kentucky
Lexington, Kentucky, 40536
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
Saint Michael's Medical Center
Newark, New Jersey, 07102
St. Joseph Hospital Orange
Orange, California, 92868
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Baystate Medical Center
Springfield, Massachusetts, 01199
AdventHealth Tampa
Tampa, Florida, 33613
Mercy Health - St Vincent Medical Center
Toledo, Ohio, 43608
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Ascension Via Christi Hospitals
Wichita, Kansas, 67226
About this study
Official title: 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
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).
Read the 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
- Being tested
- Orsiro DES
- Keywords
- Drug eluting coronary stents, Sirolimus, Bioabsorbable polymer, DES
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orsiro DESDevice
Also called Orsiro sirolimus coronary stent system
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.
| Study group | Role | What they receive |
|---|---|---|
| Orsiro sirolimus coronary stent system | Intervention with a Orsiro DES. Receives: Device: Orsiro DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12-Months
Secondary outcomes (12)
All-cause Death
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Protocol-defined Any-vessel Myocardial Infarction
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Lesion Revascularization (TLR)
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Vessel Revascularization (TVR)
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Cardiac Death or Protocol-defined Any-vessel MI
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Measured: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Stent Thrombosis
Measured: at 24 Hours, at 1 Month, at 1 Year
Number of Lesions With Device Success
Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only.
Measured: at Hospital Discharge an average of 1 day
Number of Lesions With Lesion Success
Defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method.
Measured: at Hospital Discharge an average of 1 day
Number of Participants With Procedure Success
Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).
Measured: at Hospital Discharge an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start24 Jan 2020
- Primary completion12 Jan 2022
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kandzari, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175626
- Sponsor's protocol ID
- BIOFLOW-VII
- Acronym
- BIOFLOW-VII
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2019
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Applicable de-identified individual participant data will be made available to achieve aims in approved proposals, including but not limited to sub-analysis or meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04175626
- Acronym / sponsor ID
- BIOFLOW-VII / BIOFLOW-VII
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orsiro sirolimus coronary stent system | – | Device: Orsiro DESIntervention with a Orsiro DES. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orsiro DESAlso: Orsiro sirolimus coronary stent systemOrsiro 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 | Orsiro sirolimus coronary stent system |
Primary outcome
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure
Time frame: 12-Months
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 secondary outcomes
All-cause Death
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Protocol-defined Any-vessel Myocardial Infarction
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Lesion Revascularization (TLR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Vessel Revascularization (TVR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Cardiac Death or Protocol-defined Any-vessel MI
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Stent Thrombosis
Time frame: at 24 Hours, at 1 Month, at 1 Year
Number of Lesions With Device Success
Time frame: at Hospital Discharge an average of 1 day
Number of Lesions With Lesion Success
Time frame: at Hospital Discharge an average of 1 day
Number of Participants With Procedure Success
Time frame: at Hospital Discharge an average of 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Applicable de-identified individual participant data will be made available to achieve aims in approved proposals, including but not limited to sub-analysis or meta-analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kandzari, MD principal investigator
Piedmont Heart Institute
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, Coronary, run by Biotronik, Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure (time frame: 12-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.