BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
- Conditions
- Coronary Artery DiseaseMyocardial Ischemia
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 872
- 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
- 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
- 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
CH Sud Francilien
🇫🇷Corbeil-Essonnes, France
CHU Henri Mondor
🇫🇷Créteil, France
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