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

Active, not recruiting

• Conditions: Coronary Artery Disease; Myocardial Ischemia
• Interventions: Device: Orsiro Mission DES

• Registration Number: NCT04555174
• Lead Sponsor: Biotronik AG

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.

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-18
• Study Start: 2020-09-25
• Primary Completion: 2023-01-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Study Completion: 2027-02-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 872

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orsiro Mission DES	Orsiro Mission DES	All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months.

Primary Outcome Measures

Name	Time	Method
Rate of Target Lesion Failure (TLF) at 12 months follow-up	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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (41)

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

Clinique Mutualiste; 🇫🇷 Grenoble, France

CHU Henri Mondor; 🇫🇷 Créteil, France

CH Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

CH d'Haguenau; 🇫🇷 Haguenau, France

Centre Hospitalier de La Rochelle; 🇫🇷 La Rochelle, France

Clinique Sainte Clotilde; 🇫🇷 La Réunion, France

Hôpital Louis Pasteur; 🇫🇷 Le Coudray, France

Hôpital Privé de l'Estuaire; 🇫🇷 Le Havre, France

Hôpital Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France

Clinique du Millénaire; 🇫🇷 Montpellier, France

CH de Metz; 🇫🇷 Metz, France

Clinique Pont de Chaume; 🇫🇷 Montauban, France

Clinique du Diaconat; 🇫🇷 Mulhouse, France

Clinique Ambroise Paré; 🇫🇷 Neuilly-Sur-Seine, France

Polyclinique Les Fleurs; 🇫🇷 Ollioules, France

Hôpital Lariboisière; 🇫🇷 Paris, France

CH de Pau; 🇫🇷 Pau, 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

CH de Valence; 🇫🇷 Valence, France

Clinique Saint Joseph; 🇫🇷 Trélazé, France

CH de Vannes; 🇫🇷 Vannes, France

Polyclinique Vauban; 🇫🇷 Valenciennes, France

Médpôle Lyon Villeurbanne; 🇫🇷 Villeurbanne, France

Centre de cardiologie d'Evecquemont; 🇫🇷 Évecquemont, France

Hôpital Privé du Confluent; 🇫🇷 Nantes, France

Clinique La Croix du Sud; 🇫🇷 Quint-Fonsegrives, France

Hôpital Saint Joseph; 🇫🇷 Paris, France