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

Coronary Artery Disease Clinical Trial

— BIOFLOW-VIII  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04555174
• Other study ID #: C1902
• Status: Active, not recruiting
• Start date: September 25, 2020
• Est. completion date: February 19, 2027

Study information

• Verified date: June 2024
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 872
• Est. completion date: February 19, 2027
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• Orsiro Mission DES
Percutaneous Coronary Intervention (PCI)

Locations

Country	Name	City	State
France	Clinique Esquirol Saint Hilaire	Agen
France	Clinique Axium	Aix-En-Provence
France	CH Antibes	Antibes
France	CH de Bastia	Bastia
France	GCS de cardiologie	Bayonne
France	Clinique Convert	Bourg-en-Bresse
France	Hôpital Privé Saint Martin	Caen
France	CHU de Cermont Ferrand	Clermont Ferrand
France	CH Sud Francilien	Corbeil-Essonnes
France	CHU Henri Mondor	Créteil
France	Centre de cardiologie d'Evecquemont	Évecquemont
France	Clinique Mutualiste	Grenoble
France	CH d'Haguenau	Haguenau
France	Clinique Sainte Clotilde	La Réunion
France	Centre Hospitalier de La Rochelle	La Rochelle
France	Hôpital Louis Pasteur	Le Coudray
France	Hôpital Privé de l'Estuaire	Le Havre
France	Hôpital Marie Lannelongue	Le Plessis Robinson
France	CH de Metz	Metz
France	Clinique Pont de Chaume	Montauban
France	Clinique du Millénaire	Montpellier
France	Clinique du Diaconat	Mulhouse
France	Hôpital Privé du Confluent	Nantes
France	Clinique Ambroise Paré	Neuilly-Sur-Seine
France	Polyclinique Les Fleurs	Ollioules
France	Hôpital Lariboisière	Paris
France	Hôpital Saint Joseph	Paris
France	CH de Pau	Pau
France	Clinique La Croix du Sud	Quint-Fonsegrives
France	Polyclinique Saint Laurent	Rennes
France	Centre Cardiologique du Nord	Saint-Denis
France	Clinique Rhéna / GERC	Strasbourg
France	Nouvel Hopital Civil	Strasbourg
France	CH de Toulon	Toulon
France	CH de Tourcoing	Tourcoing
France	CHRU de Tours	Tours
France	Clinique Saint Joseph	Trélazé
France	CH de Valence	Valence
France	Polyclinique Vauban	Valenciennes
France	CH de Vannes	Vannes
France	Médpôle Lyon Villeurbanne	Villeurbanne

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik AG	Biotronik France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up		6, 36, and 60 months
Secondary	Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up		6, 12, 36, and 60 months
Secondary	Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up		6, 12, 36, and 60 months
Secondary	Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up		6, 12, 36, and 60 months
Secondary	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
Secondary	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		From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days