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NCT04555174Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 21 Jun 2024

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
872 (actual)
First submitted
2 Sept 2020
Start date
25 Sept 2020
Primary completion date
18 Jan 2023
Lead sponsor
Biotronik AG
NCT number
NCT04555174

What you commit to

  • Study type: Observational
  • Participants enrolled: 872
  • From 25 Sept 2020 to the primary completion date, 18 Jan 2023
  • 41 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Subject did not sign informed consent for data release
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinique Esquirol Saint Hilaire
Coordinator of this site? Confirm its status
AgenFranceUnknown status
Clinique Axium
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Aix-en-ProvenceFranceUnknown status
CH Antibes
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AntibesFranceUnknown status
CH de Bastia
Coordinator of this site? Confirm its status
BastiaFranceUnknown status
GCS de cardiologie
Coordinator of this site? Confirm its status
BayonneFranceUnknown status
Clinique Convert
Coordinator of this site? Confirm its status
Bourg-en-BresseFranceUnknown status
Hôpital Privé Saint Martin
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CaenFranceUnknown status
CHU de Cermont Ferrand
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Clermont-FerrandFranceUnknown status
CH Sud Francilien
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Corbeil-EssonnesFranceUnknown status
CHU Henri Mondor
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CréteilFranceUnknown status
Centre de cardiologie d'Evecquemont
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ÉvecquemontFranceUnknown status
Clinique Mutualiste
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GrenobleFranceUnknown status
CH d'Haguenau
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HaguenauFranceUnknown status
Clinique Sainte Clotilde
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La RéunionFranceUnknown status
Centre Hospitalier de La Rochelle
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La RochelleFranceUnknown status
Hopital Louis Pasteur
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Le CoudrayFranceUnknown status
Hopital Prive de L Estuaire
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Le HavreFranceUnknown status
Hôpital Marie Lannelongue
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Le Plessis-RobinsonFranceUnknown status
CH de METZ
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MetzFranceUnknown status
Clinique Pont de Chaume
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MontaubanFranceUnknown status
Clinique du Millenaire
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MontpellierFranceUnknown status
Clinique du Diaconat
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MulhouseFranceUnknown status
Hôpital Privé du Confluent
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NantesFranceUnknown status
Clinique Ambroise Pare
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Neuilly-sur-SeineFranceUnknown status
Polyclinique Les Fleurs
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OllioulesFranceUnknown status
Hopital Saint Joseph
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ParisFranceUnknown status
Hôpital Lariboisière
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ParisFranceUnknown status
CH de Pau
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PauFranceUnknown status
Clinique La Croix Du Sud
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Quint-FonsegrivesFranceUnknown status
Polyclinique Saint Laurent
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RennesFranceUnknown status
Centre Cardiologique du Nord
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Saint-DenisFranceUnknown status
Nouvel Hôpital Civil
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StrasbourgFranceUnknown status
Clinique Rhéna / GERC
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StrasbourgFranceUnknown status
CH de Toulon
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ToulonFranceUnknown status
CH De Tourcoing
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TourcoingFranceUnknown status
CHRU de Tours
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ToursFranceUnknown status
Clinique Saint Joseph
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TrélazéFranceUnknown status
CH de Valence
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ValenceFranceUnknown status
Polyclinique Vauban
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ValenciennesFranceUnknown status
CH de Vannes
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VannesFranceUnknown status
Médpôle Lyon Villeurbanne
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VilleurbanneFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.