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Coronary Artery DiseaseBIOFLOW-48NCT06779630

Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

A study testing Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in people with Coronary Artery Disease, run by Teleflex at 23 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) >36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
23 sitesin 6 countries
Study dates
18 Jul 2025to Sep 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Subject is ≥ 18 years of age
  • Subject is able to understand the nature of the study and provide written informed consent.
  • For sites outside of the United States: Note: For subjects presenting with STEMI and not in a position to read, interpret and sign the informed consent form, oral informed consent is required.
  • Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
  • Subject is an acceptable candidate for CABG.
  • Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
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  • Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
  • Subject is willing and able to comply with study follow-up requirements.
  • Angiographic inclusion criteria:
  • Subject has only one target lesion in a native coronary artery to be treated with the investigational device.
  • Note: One additional non-target lesion may be treated with a non-investigational treatment (e.g. stent, balloon angioplasty, atherectomy) with the exception of brachytherapy, if it is located in a different coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis < 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)
  • Note: Multiple focal stenoses will be considered as a single lesion if they are amenable to treatment with a single study device.
  • Target lesion must be > 36 mm and ≤ 44 mm in length by operator visual estimate and must be amenable to treatment with a single study device.
  • Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
  • For sites in United States: Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
  • For sites outside of the United States: Target lesion can be de novo, restenotic or in-stent restenotic, and must be located in a native coronary artery.
  • Target lesion must have angiographic evidence of ≥ 50% and < 100% stenosis (by operator visual estimate which may be assisted by QCA / IVUS / OCT). Target lesion stenosis < 70% should have clinical justification for treatment as per local standards.
  • Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow > 1.
  • For sites outside of the United States: Note: For STEMI, TIMI flow > 1 prior to stent implantation (after opening the vessel with a guide wire or a balloon).

Who cannot join

  • For sites in United States only: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
  • Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
  • Subject is hemodynamically unstable.
  • 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), acrylic, fluoropolymers, silicon carbide, PLLA or sirolimus.
  • Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within <72 hours prior to the index procedure.
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  • Future planned PCI (including staged procedure) or CABG after the index procedure.
  • Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy 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.
  • Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
  • Subject will refuse blood transfusions.
  • Subject has a left ventricular ejection fraction (LVEF) < 30% within 6 months prior to or during the index procedure that was documented by any method.
  • Subject is dialysis dependent or has impaired renal function (i.e., serum creatinine > 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure).
  • Subject has a documented white blood cell count < 3,000 white blood cells/mm3 or a documented platelet count < 100,000 platelets/mm3 or > 700,000 platelets/mm3.
  • Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).
  • Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission.
  • Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines.
  • Subject has life expectancy of < 1 year.
  • Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.
  • In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
  • Angiographic exclusion criteria:
  • Target lesion is excluded if it meets any of the following criteria:
  • Lesion is located within or treated through a saphenous vein graft or arterial graft.
  • Lesion location is within the left main coronary artery.
  • Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries.
  • Involves a side branch of > 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
  • Lesion is totally occluded (100% stenosis).
  • For sites in United States only: Lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).
  • Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
  • Site sites in the United States: Target vessel has angiographic evidence of thrombus.
  • For sites outside of the United States: Target vessel has angiographic evidence of unresolved large thrombus burden despite of thrombus aspiration.
  • Note: Thrombus aspiration is left at the discretion of the implanting physician.
  • Target vessel was treated with brachytherapy any time prior to the index procedure.
  • Unsuccessful target lesion pre-dilatation, defined as residual stenosis > 50% (by visual estimation) and/or angiographic complications (e.g., distal embolization, side branch closure, dissection greater than National Heart, Lung, Blood Institute type C), and/or, for sites outside of the United States, coronary aneurysms.
  • Non-target lesion is excluded if it meets any of the following criteria:
  • Any of the target lesion angiographic exclusion criteria except for 1c
  • Lesion is located within the target vessel.
  • Lesion is > 36 mm by operator visual estimate.
  • Lesion requires additional, unplanned stents to treat a complication.
  • Lesion treatment is not deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis < 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)

Trial locations and contacts

23 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

BIOFLOW-48 Project Manager contact

1-866-246-6990

bioflow-48@teleflex.com

23 sites in 6 countries

United States10 sites, 10 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

    Recruiting

  • John Muir Medical Center

    Concord, California, 94520

    Recruiting

  • Baylor Scott & White The Heart Hospital - Dallas

    Dallas, Texas, 75226

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Recruiting

  • Ascension Texas Cardiovascular

    Kyle, Texas, 78640

    Recruiting

  • North Shore University Hospital

    Manhasset, New York, 11030

    Recruiting

  • Columbia University Irving Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

    Recruiting

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

    Recruiting

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

    Recruiting

Other trials in United States

France4 sites

  • Clinique Louis Pasteur

    Essey-lès-Nancy, Grand Est, 54270

    Active, not recruiting

  • Hospices Civils de Lyon - CHU de Lyon

    Lyon, Auvergne-Rhône-Alpes, 69002

    Active, not recruiting

  • Hôpital Cochin - Groupe AP-HP

    Paris, Île-de-France Region, 75014

    Active, not recruiting

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, 06700

    Active, not recruiting

Other trials in France

Germany4 sites

  • Segeberger Kliniken GmbH

    Bad Segeberg, Schleswig-Holstein, 23795

    Active, not recruiting

  • Klinikum Fürth

    Fürth, Bavaria, 90766

    Active, not recruiting

  • Universitätsklinikum Mannheim, I. Medizinische Klinik

    Mannheim, Baden-Wurttemberg, 68167

    Active, not recruiting

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

    Withdrawn

Other trials in Germany

Austria2 sites

  • Klinische Abteilung für Kardiologie, Medizinische Universität Graz

    Graz, Styria, 8036

    Active, not recruiting

  • Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien

    Vienna, State of Vienna, 1090

    Active, not recruiting

Other trials in Austria

Switzerland2 sites

  • University hospital Basel

    Basel, Canton of Basel-City, 4031

    Active, not recruiting

  • Istituto Cardiocentro Ticino

    Lugano, Canton Ticino, 6900

    Active, not recruiting

Other trials in Switzerland

Poland1 site

  • Miedziowe Centrum Zdrowia SA

    Lubin, Lower Silesian Voivodeship, 59-301

    Active, not recruiting

Other trials in Poland

About this study

Official title: A Prospective Multicenter Single Arm Study to Assess the Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System for the Treatment of Subjects With Atherosclerotic Lesion(s)

The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) >36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.

Patients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure. Patients enrolled outside of the United States will be followed through 5 years post index procedure with additional follow-up visits at 3 and 5 years post index procedure.

Being tested
Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System
Keywords
Orsiro Mission, Sirolimus-Eluting, Coronary Stent System, coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent SystemDevice

    Orsiro Mission is composed of 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 groups in NCT06779630
Study groupRoleWhat they receive
Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent SystemExperimentalNot described
Receives: Device: Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Lesion Failure (TLF) rate at 12 months post-index procedure

    The primary endpoint will be target lesion failure (TLF) rate at 12 months post-index procedure. TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).

    Measured: 12 months

Secondary outcomes (11)

  1. Device success

    Device success, defined as attainment of < 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only.

    Measured: Hospital Discharge (6-24 hours post-index procedure)

  2. Procedure success

    Procedure success, defined as attainment of < 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only without occurrence of in-hospital major adverse cardiac events (MACE).

    Measured: Hospital Discharge (6-24 hours post-index procedure)

  3. All-cause death

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  4. Any myocardial infarction (MI)

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  5. Cardiac death or myocardial infarction (MI)

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  6. Major cardiac adverse events (MACE) and individual MACE components

    MACE is defined as a composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically driven target lesion revascularization (TLR).

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  7. Target lesion failure (TLF) and individual TLF components

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

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  8. Target vessel failure (TVF) and individual TVF components

    TVF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), and clinically driven target vessel revascularization (CD-TVR).

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  9. Target lesion revascularization (TLR)

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  10. Target vessel revascularization (TVR)

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

  11. Stent thrombosis

    Stent thrombosis will be assessed according to Academic Research Consortium - 2 (ARC-2) definitions.

    Measured: 1, 6, 12 months and 2, 3, and 5 years post-index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start18 Jul 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06779630
Sponsor's protocol ID
G240288
Acronym
BIOFLOW-48
Status last verified
Jan 2026
First submitted
14 Jan 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No IPD sharing is planned at this time. This study evaluates an investigational device under an FDA IDE. The sponsor may consider sharing de-identified IPD under controlled access following completion of primary endpoint analysis and regulatory review. Summary results will be reported in scientific publications and public registries.

Questions about this trial

What is this clinical trial studying?

A study testing Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in people with Coronary Artery Disease, run by Teleflex at 23 sites in 6 countries.

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 19 inclusion and 40 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, France, Germany, Austria, Switzerland and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BIOFLOW-48 Project Manager (1-866-246-6990, bioflow-48@teleflex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) rate 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?

On the ClinicalTrials.gov record for NCT06779630.

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 5 Nov 2026.

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