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

N/AActive Not RecruitingNCT04555174

Biotronik AG872 enrolled

Overview

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).

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

872

Conditions

Coronary Artery Disease Myocardial Ischemia

Interventions

Orsiro Mission DESDEVICE

Percutaneous Coronary Intervention (PCI)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (41)

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Rate of Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up

Time frame: 6, 36, and 60 months

Rate of Target Vessel Revascularization (TVR) at 6, 12, 36, and 60 months follow-up

Time frame: 6, 12, 36, and 60 months

Rate of Target Lesion Revascularization (TLR) at 6, 12, 36, and 60 months follow-up

Time frame: 6, 12, 36, and 60 months

Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up

Time frame: 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

Time frame: 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

Time frame: From the intervention/procedure/surgery until hospital discharge, assessed up to 3 days

Data from ClinicalTrials.gov

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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

...and 31 more locations