Coronary Artery DiseaseBIOFLOW-VIIINCT04555174
BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Biotronik AG at 41 sites in France.
Trial summary
The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- Orsiro Mission DES
- Type of treatment
- Medical device
- How many people
- 872 participants
- Where
- 41 sitesFrance
- Study dates
- 25 Sep 2020to 19 Feb 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Orsiro Mission is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40 mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.
Who may be able to join
- Symptomatic coronary artery disease intended to be treated with an Orsiro Mission DES (silent ischemia is permitted)
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is ≥ 18 years of age
Who cannot join
- Subject did not sign informed consent for data release
- Pregnancy
- Known allergy (which cannot be pre-treated) to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt- chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), silicon carbide, PLLA, mTOR inhibiting drugs such as sirolimus, or contrast media
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
France41 sites
Clinique Esquirol Saint Hilaire
Agen, 47002
Clinique Axium
Aix-en-Provence, 13090
CH Antibes
Antibes, 06600
CH de Bastia
Bastia, 20604
GCS de cardiologie
Bayonne, 64109
Clinique Convert
Bourg-en-Bresse, 1000
Hôpital Privé Saint Martin
Caen, 14050
CHU de Cermont Ferrand
Clermont-Ferrand, 63000
CH Sud Francilien
Corbeil-Essonnes, 91100
CHU Henri Mondor
Créteil, 94000
Centre de cardiologie d'Evecquemont
Évecquemont, 78740
Clinique Mutualiste
Grenoble, 38000
CH d'Haguenau
Haguenau, 67504
Clinique Sainte Clotilde
La Réunion, 97490
Centre Hospitalier de La Rochelle
La Rochelle, 17000
Hôpital Louis Pasteur
Le Coudray, 28630
Hôpital Privé de l'Estuaire
Le Havre, 76620
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
CH de Metz
Metz, 57038
Clinique Pont de Chaume
Montauban, 82000
Clinique du Millénaire
Montpellier, 34000
Clinique du Diaconat
Mulhouse, 68100
Hôpital Privé du Confluent
Nantes, 44277
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
Polyclinique Les Fleurs
Ollioules, 83192
Hôpital Lariboisière
Paris, 75475
Hôpital Saint Joseph
Paris, 75674
CH de Pau
Pau, 64046
Clinique La Croix du Sud
Quint-Fonsegrives, 31130
Polyclinique Saint Laurent
Rennes, 35700
Centre Cardiologique du Nord
Saint-Denis, 93200
Clinique Rhéna / GERC
Strasbourg, 67000
Nouvel Hopital Civil
Strasbourg, 67100
CH de Toulon
Toulon, 83056
CH de Tourcoing
Tourcoing, 59200
CHRU de Tours
Tours, 37044
Clinique Saint Joseph
Trélazé, 49800
CH de Valence
Valence, 26000
Polyclinique Vauban
Valenciennes, 59300
CH de Vannes
Vannes, 56017
Médpôle Lyon Villeurbanne
Villeurbanne, 69100
About this study
Official title: BIOTRONIK - SaFety and Performance Registry for an aLl-comers Subject Population With the Limus Eluting Orsiro Mission Stent System Within Daily Clinical Practice: BIOFLOW-VIII
The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Read the detailed description
BIOFLOW-VIII is a national, prospective, non-randomized, multi-center, open-label registry to confirm both, the acute performance as well as the mid- and long-term safety and clinical performance of the Orsiro Mission stent in an all-comers patient population within daily clinical practice.
A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone.
A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Being tested
- Orsiro Mission DES
- Keywords
- Observational registry, All-comers open-label registry, Percutaneous Coronary Intervention (PCI), Coronary revascularization, Orsiro Mission Drug Eluting Stent (DES), Stenting
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orsiro Mission DESDevice
Percutaneous Coronary Intervention (PCI)
| Study group | Role | What they receive |
|---|---|---|
| Orsiro Mission DES | All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months. Receives: Device: Orsiro Mission DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Target Lesion Failure (TLF) at 12 months follow-up
TLF according to Academic Research Consortium-2 (ARC-2) definition: Composite of Cardiovascular Death, target-vessel Myocardial Infarction and clinically-driven Target Lesion Revascularization
Measured: 12 months
Secondary outcomes (6)
Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up
Measured: 6, 36, and 60 months
Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up
Measured: 6, 12, 36, and 60 months
Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up
Measured: 6, 12, 36, and 60 months
Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up
Measured: 6, 12, 36, and 60 months
Percent of participants with Clinical Device Success defined as attainment of < 30% residual stenosis of the target lesion using Orsiro Mission only
Measured: Immediately after the intervention/procedure/surgery
Percent of participants with Clinical Procedural Success defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method without occurrence of in-hospital death, myocardial infarction or target lesion revascularization
Measured: From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start25 Sep 2020
- Primary completion18 Jan 2023
- Study completion19 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 872 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik France
- Responsible party
- Sponsor
- Investigators
- Paul Barragan, MD, Principal investigator, Polyclinique les Fleurs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555174
- Sponsor's protocol ID
- C1902
- Acronym
- BIOFLOW-VIII
- Status last verified
- Jun 2024
- First submitted
- 2 Sep 2020
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary outcome data will be shared after publication of it.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK - SaFety and Performance Registry for an aLl-comers Subject Population With the Limus Eluting Orsiro Mission Stent System Within Daily Clinical Practice: BIOFLOW-VIII
- ClinicalTrials.gov ID
- NCT04555174
- Acronym / sponsor ID
- BIOFLOW-VIII / C1902
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Keywords
- Observational registry, All-comers open-label registry, Percutaneous Coronary Intervention (PCI), Coronary revascularization, Orsiro Mission Drug Eluting Stent (DES), Stenting
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 872 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Collaborators
- Biotronik France
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 19 Feb 2027 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Detailed description
BIOFLOW-VIII is a national, prospective, non-randomized, multi-center, open-label registry to confirm both, the acute performance as well as the mid- and long-term safety and clinical performance of the Orsiro Mission stent in an all-comers patient population within daily clinical practice.
A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone.
A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orsiro Mission DES | – | Device: Orsiro Mission DESAll subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orsiro Mission is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40 mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.
Key inclusion criteria (4 listed)
- Symptomatic coronary artery disease intended to be treated with an Orsiro Mission DES (silent ischemia is permitted)
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is ≥ 18 years of age
Key exclusion criteria (3 listed)
- Subject did not sign informed consent for data release
- Pregnancy
- Known allergy (which cannot be pre-treated) to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt- chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), silicon carbide, PLLA, mTOR inhibiting drugs such as sirolimus, or contrast media
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 Mission DESPercutaneous Coronary Intervention (PCI) | Device | Orsiro Mission DES |
Primary outcome
Rate of Target Lesion Failure (TLF) at 12 months follow-up
Time frame: 12 months
TLF according to Academic Research Consortium-2 (ARC-2) definition: Composite of Cardiovascular Death, target-vessel Myocardial Infarction and clinically-driven Target Lesion Revascularization
6 secondary outcomes
Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up
Time frame: 6, 36, and 60 months
Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up
Time frame: 6, 12, 36, and 60 months
Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up
Time frame: 6, 12, 36, and 60 months
Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up
Time frame: 6, 12, 36, and 60 months
Percent of participants with Clinical Device Success defined as attainment of < 30% residual stenosis of the target lesion using Orsiro Mission only
Time frame: Immediately after the intervention/procedure/surgery
Percent of participants with Clinical Procedural Success defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method without occurrence of in-hospital death, myocardial infarction or target lesion revascularization
Time frame: From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No. The primary outcome data will be shared after publication of it.
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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.
Paul Barragan, MD principal investigator
Polyclinique les Fleurs
41 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 Myocardial Ischemia, run by Biotronik AG at 41 sites in France.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in France. 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?
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?
Rate of Target Lesion Failure (TLF) at 12 months follow-up (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 21 Jun 2024.