Clinical trial NCT04555174: BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
Collaborators: name: Biotronik France
First posted: 2020-09-18
Enrollment: 872
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Target Lesion Failure (TLF) at 12 months follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up
timeFrame: 6, 36, and 60 months
measure: Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up
timeFrame: 6, 12, 36, and 60 months
measure: Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up
timeFrame: 6, 12, 36, and 60 months
measure: Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up
timeFrame: 6, 12, 36, and 60 months
measure: Percent of participants with Clinical Device Success defined as attainment of < 30% residual stenosis of the target lesion using Orsiro Mission only
timeFrame: Immediately after the intervention/procedure/surgery
measure: 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
timeFrame: From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Esquirol Saint Hilaire
city: Aix-En-Provence
country: France
facility: Clinique Axium
city: Antibes
country: France
facility: CH Antibes
city: Bastia
country: France
facility: CH de Bastia
city: Bayonne
country: France
facility: GCS de cardiologie
city: Bourg-en-Bresse
country: France
facility: Clinique Convert
city: Caen
country: France
facility: Hôpital Privé Saint Martin
city: Clermont Ferrand
country: France
facility: CHU de Cermont Ferrand
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: Clinique Mutualiste
city: Haguenau
country: France
facility: CH d'Haguenau
city: La Rochelle
country: France
facility: Centre Hospitalier de La Rochelle
city: La Réunion
country: France
facility: Clinique Sainte Clotilde
city: Le Coudray
country: France
facility: Hôpital Louis Pasteur
city: Le Havre
country: France
facility: Hôpital Privé de l'Estuaire
city: Le Plessis Robinson
country: France
facility: Hôpital Marie Lannelongue
city: Metz
country: France
facility: CH de Metz
city: Montauban
country: France
facility: Clinique Pont de Chaume
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Mulhouse
country: France
facility: Clinique du Diaconat
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Neuilly-Sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Pau
country: France
facility: CH de Pau
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix du Sud
city: Rennes
country: France
facility: Polyclinique Saint Laurent
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Strasbourg
country: France
facility: Clinique Rhéna / GERC
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Toulon
country: France
facility: CH de Toulon
city: Tourcoing
country: France
facility: CH de Tourcoing
city: Tours
country: France
facility: CHRU de Tours
city: Trélazé
country: France
facility: Clinique Saint Joseph
city: Valence
country: France
facility: CH de Valence
city: Valenciennes
country: France
facility: Polyclinique Vauban
city: Vannes
country: France
facility: CH de Vannes
city: Villeurbanne
country: France
facility: Médpôle Lyon Villeurbanne
city: Évecquemont
country: France
facility: Centre de cardiologie d'Evecquemont
Study officials:
affiliation: Polyclinique les Fleurs
name: Paul Barragan, MD
role: PRINCIPAL_INVESTIGATOR
References: