BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
BIOFLOW-VIII
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
1 other identifier
observational
872
1 country
41
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedStudy Start
First participant enrolled
September 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2027
ExpectedJune 21, 2024
June 1, 2024
2.3 years
September 2, 2020
June 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (6)
Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up
6, 36, and 60 months
Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up
6, 12, 36, and 60 months
Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up
6, 12, 36, and 60 months
Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up
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
Immediately after the intervention/procedure/surgery
- +1 more secondary outcomes
Study Arms (1)
Orsiro Mission DES
All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik AGlead
- Biotronik Francecollaborator
Study Sites (41)
Clinique Esquirol Saint Hilaire
Agen, 47002, France
Clinique Axium
Aix-en-Provence, 13090, France
CH Antibes
Antibes, 06600, France
CH de Bastia
Bastia, 20604, France
GCS de cardiologie
Bayonne, 64109, France
Clinique Convert
Bourg-en-Bresse, 1000, France
Hôpital Privé Saint Martin
Caen, 14050, France
CHU de Cermont Ferrand
Clermont-Ferrand, 63000, France
CH Sud Francilien
Corbeil-Essonnes, 91100, France
CHU Henri Mondor
Créteil, 94000, France
Centre de cardiologie d'Evecquemont
Évecquemont, 78740, France
Clinique Mutualiste
Grenoble, 38000, France
CH d'Haguenau
Haguenau, 67504, France
Clinique Sainte Clotilde
La Réunion, 97490, France
Centre Hospitalier de La Rochelle
La Rochelle, 17000, France
Hôpital Louis Pasteur
Le Coudray, 28630, France
Hôpital Privé de l'Estuaire
Le Havre, 76620, France
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350, France
CH de Metz
Metz, 57038, France
Clinique Pont de Chaume
Montauban, 82000, France
Clinique du Millénaire
Montpellier, 34000, France
Clinique du Diaconat
Mulhouse, 68100, France
Hôpital Privé du Confluent
Nantes, 44277, France
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200, France
Polyclinique Les Fleurs
Ollioules, 83192, France
Hôpital Lariboisière
Paris, 75475, France
Hôpital Saint Joseph
Paris, 75674, France
CH de Pau
Pau, 64046, France
Clinique La Croix du Sud
Quint-Fonsegrives, 31130, France
Polyclinique Saint Laurent
Rennes, 35700, France
Centre Cardiologique du Nord
Saint-Denis, 93200, France
Clinique Rhéna / GERC
Strasbourg, 67000, France
Nouvel Hopital Civil
Strasbourg, 67100, France
CH de Toulon
Toulon, 83056, France
CH de Tourcoing
Tourcoing, 59200, France
CHRU de Tours
Tours, 37044, France
Clinique Saint Joseph
Trélazé, 49800, France
CH de Valence
Valence, 26000, France
Polyclinique Vauban
Valenciennes, 59300, France
CH de Vannes
Vannes, 56017, France
Médpôle Lyon Villeurbanne
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Barragan, MD
Polyclinique les Fleurs
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 18, 2020
Study Start
September 25, 2020
Primary Completion
January 18, 2023
Study Completion (Estimated)
February 19, 2027
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
The primary outcome data will be shared after publication of it.