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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Ischemia; Coronary Artery Disease
• Intervention / Treatment: Device: Orsiro Mission 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 Type: Observational
• Enrollment (Actual): 872

Contacts and Locations

• Study Contact: Name: Kathrin Meinhardt, MSc; Phone Number: +41754427453; Email: kathrin.meinhardt@biotronik.com
• Study Contact Backup: Name: Mathilde Violland; Phone Number: +33789831147; Email: mathilde.violland@biotronik.com

Study Locations

• France
  • Agen, France, 47002
    • Clinique Esquirol Saint Hilaire
  • Aix-En-Provence, France, 13090
    • Clinique Axium
  • Antibes, France, 06600
    • CH Antibes
  • Bastia, France, 20604
    • CH de Bastia
  • Bayonne, France, 64109
    • GCS de cardiologie
  • Bourg-en-Bresse, France, 1000
    • Clinique Convert
  • Caen, France, 14050
    • Hôpital Privé saint Martin
  • Clermont Ferrand, France, 63000
    • CHU de Cermont Ferrand
  • Corbeil-Essonnes, France, 91100
    • CH SUd Francilien
  • Créteil, France, 94000
    • CHU Henri Mondor
  • Grenoble, France, 38000
    • Clinique Mutualiste
  • Haguenau, France, 67504
    • CH d'Haguenau
  • La Rochelle, France, 17000
    • Centre Hospitalier de La Rochelle
  • La Réunion, France, 97490
    • Clinique Sainte Clotilde
  • Le Coudray, France, 28630
    • Hôpital Louis Pasteur
  • Le Havre, France, 76620
    • Hôpital Privé de l'Estuaire
  • Le Plessis Robinson, France, 92350
    • Hopital Marie Lannelongue
  • Metz, France, 57038
    • CH de METZ
  • Montauban, France, 82000
    • Clinique Pont de Chaume
  • Montpellier, France, 34000
    • Clinique du Millenaire
  • Mulhouse, France, 68100
    • Clinique du Diaconat
  • Nantes, France, 44277
    • Hôpital Privé du Confluent
  • Neuilly-Sur-Seine, France, 92200
    • Clinique Ambroise Pare
  • Ollioules, France, 83192
    • Polyclinique les Fleurs
  • Paris, France, 75475
    • Hopital Lariboisiere
  • Paris, France, 75674
    • Hopital Saint Joseph
  • Pau, France, 64046
    • CH de Pau
  • Quint-Fonsegrives, France, 31130
    • Clinique La Croix du Sud
  • Rennes, France, 35700
    • Polyclinique Saint Laurent
  • Saint-Denis, France, 93200
    • Centre Cardiologique du Nord
  • Strasbourg, France, 67000
    • Clinique Rhéna / GERC
  • Strasbourg, France, 67100
    • Nouvel Hopital Civil
  • Toulon, France, 83056
    • CH de Toulon
  • Tourcoing, France, 59200
    • CH de Tourcoing
  • Tours, France, 37044
    • Chru de Tours
  • Trélazé, France, 49800
    • Clinique Saint Joseph
  • Valence, France, 26000
    • CH de Valence
  • Valenciennes, France, 59300
    • Polyclinique Vauban
  • Vannes, France, 56017
    • CH de Vannes
  • Villeurbanne, France, 69100
    • Médpôle Lyon Villeurbanne
  • Évecquemont, France, 78740
    • Centre de cardiologie d'Evecquemont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Orsiro Mission DES; All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months.	Device: Orsiro Mission DES; Percutaneous Coronary Intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Target Lesion Failure (TLF) at 12 months follow-up	TLF according to Academic Research Consortium-2 (ARC-2) definition: Composite of Cardiac Death, target-vessel Myocardial Infarction and clinically-driven Target Lesion Revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Biotronik AG
• Collaborators: Biotronik France

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): January 18, 2023
• Study Completion (Anticipated): February 19, 2027

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention (PCI); Observational registry; Stenting; Coronary revascularization; All-comers open-label registry; Orsiro Mission Drug Eluting Stent (DES)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: C1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The primary outcome data will be shared after publication of it.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No