BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry (BIOFLOW-VIII)

June 19, 2024 updated by: Biotronik AG

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
872

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Agen, France, 47002
        • Clinique Esquirol Saint Hilaire
      • Aix-En-Provence, France, 13090
        • Clinique Axium
      • Antibes, France, 06600
        • CH Antibes
      • Bastia, France, 20604
        • CH de Bastia
      • Bayonne, France, 64109
        • GCS de cardiologie
      • Bourg-en-Bresse, France, 1000
        • Clinique Convert
      • Caen, France, 14050
        • Hôpital Privé Saint Martin
      • Clermont Ferrand, France, 63000
        • CHU de Cermont Ferrand
      • Corbeil-Essonnes, France, 91100
        • Ch Sud Francilien
      • Créteil, France, 94000
        • CHU Henri Mondor
      • Grenoble, France, 38000
        • Clinique Mutualiste
      • Haguenau, France, 67504
        • CH d'Haguenau
      • La Rochelle, France, 17000
        • Centre Hospitalier de La Rochelle
      • La Réunion, France, 97490
        • Clinique sainte Clotilde
      • Le Coudray, France, 28630
        • Hopital Louis Pasteur
      • Le Havre, France, 76620
        • Hôpital Privé de l'Estuaire
      • Le Plessis Robinson, France, 92350
        • Hopital Marie Lannelongue
      • Metz, France, 57038
        • CH de METZ
      • Montauban, France, 82000
        • Clinique Pont de Chaume
      • Montpellier, France, 34000
        • Clinique du Millénaire
      • Mulhouse, France, 68100
        • Clinique du Diaconat
      • Nantes, France, 44277
        • Hôpital Privé du Confluent
      • Neuilly-Sur-Seine, France, 92200
        • Clinique Ambroise Pare
      • Ollioules, France, 83192
        • Polyclinique Les Fleurs
      • Paris, France, 75475
        • Hôpital Lariboisière
      • Paris, France, 75674
        • Hopital Saint Joseph
      • Pau, France, 64046
        • CH de Pau
      • Quint-Fonsegrives, France, 31130
        • Clinique La Croix Du Sud
      • Rennes, France, 35700
        • Polyclinique Saint Laurent
      • Saint-Denis, France, 93200
        • Centre Cardiologique du Nord
      • Strasbourg, France, 67000
        • Clinique Rhéna / GERC
      • Strasbourg, France, 67100
        • Nouvel Hopital Civil
      • Toulon, France, 83056
        • CH de Toulon
      • Tourcoing, France, 59200
        • CH de Tourcoing
      • Tours, France, 37044
        • CHRU de Tours
      • Trélazé, France, 49800
        • Clinique Saint Joseph
      • Valence, France, 26000
        • CH de Valence
      • Valenciennes, France, 59300
        • Polyclinique Vauban
      • Vannes, France, 56017
        • CH de Vannes
      • Villeurbanne, France, 69100
        • Médpôle Lyon Villeurbanne
      • Évecquemont, France, 78740
        • Centre de cardiologie d'Evecquemont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Orsiro Mission DES
All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months.
Device: Orsiro Mission DES
Percutaneous Coronary Intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up
Time Frame: 6, 36, and 60 months
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
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
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
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
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
From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biotronik France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Barragan, MD, Polyclinique Les Fleurs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The primary outcome data will be shared after publication of it.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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