BIOTRONIK - BIOFLOW-III Registry French Satellite
- Conditions
- Coronary Artery Diseases
- Interventions
- Device: Drug Eluting Stent (DES)
- Registration Number
- NCT02273648
- Lead Sponsor
- Biotronik France
- Brief Summary
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Symptomatic coronary artery disease
- 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 intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Orsiro Drug Eluting Stent (DES) Subjects requiring coronary revascularization with Drug Eluting Stents (DES) as well as Subjects presenting with 1. Diabetes (all types) at least 300 subjects should be included and analyzed in this segment 2. Small vessels (≤2.75 mm) approx. 150 subjects 3. Chronic total occlusion (CTO) approx. 50 subjects 4. Acute Myocardial Infarction (incl. STEMI and NSTEMI) approx. 100 subjects 5. Multivessels approx. 250 subjects 6. In stent restenosis approx. 100 subjects 7. Different type of DAPT interruption : \<3 months, between 3 and 6 months, after 6 months approx. 300 subjects subjects who stopped \<3 months
- Primary Outcome Measures
Name Time Method Target Lesion Failure (TLF) 12 months Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)
- Secondary Outcome Measures
Name Time Method Target Vessel Revascularization (TVR) 6, 12, 24, 36, 48 and 60 months Any repeat revascularization of the target vessel. (Vascular bypass or angioplasty)
Target Lesion Revascularization (TLR) 6, 12, 24, 36, 48 and 60 months Target Lesion Revascularization (Vascular bypass or angioplasty)
Clinical Procedural Success up to seven days Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device\* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.
Stent Thrombosis 6, 12, 24, 36, 48 and 60 months Definite, Probable and Possible Stent Thrombosis
Clinical Device Success up to 1 day Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy.
TLF 6, 24, 36, 48 and 60 months Defined as the composite of Cardiac death, Target vessel Q-wave or non-Q wave Myocardial Infarction (MI) (i.e., Q-wave MI that cannot be attributed to a non-target vessel), clinically driven Target Lesion Revascularization (TLR) and Emergent Coronary Artery Bypass Grafting (CABG).
Trial Locations
- Locations (50)
CH d'Aix en Provence
🇫🇷Aix-en-Provence, France
Clinique de l'Europe
🇫🇷Amiens, France
Centre Hospitalier d'Antibes
🇫🇷Antibes, France
Clinique Rhône Durance
🇫🇷Avignon, France
Hopital Henri Duffaut
🇫🇷Avignon, France
Clinique Keraudren
🇫🇷Brest, France
CHU de Clermont Ferrand, Hôpital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Clinique Louis Pasteur
🇫🇷Essey-les-Nancy, France
CHU Fort de France
🇫🇷Fort-de-France, France
Groupe Hospitalier Mutualiste
🇫🇷Grenoble, France
CH La Rochelle
🇫🇷La Rochelle, France
Montpellier le Millenaire
🇫🇷Montpellier, France
Clinique du Diaconat Fonderie
🇫🇷Mulhouse, France
Polyclinique les Fleurs
🇫🇷Ollioules, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Centre Hospitalier de Pau
🇫🇷Pau, France
CHU Reunion
🇫🇷Saint-Denis, France
Hôpital privé Claude Galien
🇫🇷Quincy, France
CHIV de Villeneuve St Georges
🇫🇷Villeneuve-Saint-Georges, France
CHU de la Timone
🇫🇷Marseille, France
Clinique Saint Hilaire
🇫🇷Rouen, France
CHU Point-à-Pitre
🇫🇷La Guadeloupe, France
Hôpital privé de l'Estuaire
🇫🇷Le Havre, France
Centre Hospitalier St Brieuc
🇫🇷St Brieuc, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
CH de Valence
🇫🇷Valence, France
Centre Hospitalier de Bastia
🇫🇷Bastia, France
HP St Martin, Service de Cardiologie
🇫🇷Caen, France
Clinique Pont de Chaume
🇫🇷Montauban, France
Clinique Ste Clotilde
🇫🇷Sainte-Clotilde, France
Clinique la fourcade
🇫🇷Bayonne, France
Clinique St Augustin, Service Cardiologie Interventionnelle
🇫🇷Bordeaux, France
Hôpital Louis Pasteur
🇫🇷Le Coudray, France
Hôpital Privé St Martin
🇫🇷Pessac, France
Centre Cardiologique du Nord (CCN)
🇫🇷St Denis, France
Lyon Saint Joseph Saint Luc
🇫🇷Lyon, France
Clinique Convert, Cardiologie Interventionnelle
🇫🇷Bourg-en-Bresse, France
CH Sud Francilien
🇫🇷Corbeil, France
Centre Hospitalier de la Roche-sur-Yon
🇫🇷La Roche-sur-Yon, France
CH de Versailles
🇫🇷Le Chesnay, France
CHRU de Lille
🇫🇷Lille, France
Hôpital Nord de Marseille, Service de Cardiologie
🇫🇷Marseille, France
Clinique les Fontaines
🇫🇷Melun, France
Centre Hospitalier Annecy
🇫🇷Metz Tessy, France
Clinique de l'Orangerie
🇫🇷Strasbourg, France
Clinique St Gatien
🇫🇷Tours, France
Clinique St Joseph
🇫🇷Trélazé, France
CHU de Nantes
🇫🇷Nantes, France
CHU Nimes
🇫🇷Nimes, France
CHU Toulouse Rangueil
🇫🇷Toulouse, France