Coronary Artery Disease, Myocardial Ischemia
Conditions
Keywords
Observational registry, All-comers open-label registry, Percutaneous Coronary Intervention (PCI), Coronary revascularization, Orsiro Mission Drug Eluting Stent (DES), Stenting
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.
Interventions
DEVICEOrsiro Mission DES
Percutaneous Coronary Intervention (PCI)
Sponsors
Biotronik France
Biotronik AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Target Lesion Failure (TLF) at 6, 36 and 60 months follow-up | 6, 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 |
| Rate of Definite Stent Thrombosis at 6, 12, 36, and 60 months follow-up | 6, 12, 36, and 60 months |
Countries
France
Outcome results
None listed