Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biotronik France | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orsiro Mission DES | All subjects will be implanted with the Limus Eluting Orsiro Mission Stent System and followed up until 60 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orsiro Mission DES | Device | Percutaneous Coronary Intervention (PCI) |
|
| 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 Cardiovascular Death, target-vessel Myocardial Infarction and clinically-driven Target Lesion Revascularization | 12 months |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Barragan, MD | Polyclinique les Fleurs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Esquirol Saint Hilaire | Agen | 47002 | France | |||
| Clinique Axium |
The primary outcome data will be shared after publication of it.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Aix-en-Provence |
| 13090 |
| France |
| CH Antibes | Antibes | 06600 | France |
| CH de Bastia | Bastia | 20604 | France |
| GCS de cardiologie | Bayonne | 64109 | France |
| Clinique Convert | Bourg-en-Bresse | 1000 | France |
| Hôpital Privé Saint Martin | Caen | 14050 | France |
| CHU de Cermont Ferrand | Clermont-Ferrand | 63000 | France |
| CH Sud Francilien | Corbeil-Essonnes | 91100 | France |
| CHU Henri Mondor | Créteil | 94000 | France |
| Centre de cardiologie d'Evecquemont | Évecquemont | 78740 | France |
| Clinique Mutualiste | Grenoble | 38000 | France |
| CH d'Haguenau | Haguenau | 67504 | France |
| Clinique Sainte Clotilde | La Réunion | 97490 | France |
| Centre Hospitalier de La Rochelle | La Rochelle | 17000 | France |
| Hôpital Louis Pasteur | Le Coudray | 28630 | France |
| Hôpital Privé de l'Estuaire | Le Havre | 76620 | France |
| Hôpital Marie Lannelongue | Le Plessis-Robinson | 92350 | France |
| CH de Metz | Metz | 57038 | France |
| Clinique Pont de Chaume | Montauban | 82000 | France |
| Clinique du Millénaire | Montpellier | 34000 | France |
| Clinique du Diaconat | Mulhouse | 68100 | France |
| Hôpital Privé du Confluent | Nantes | 44277 | France |
| Clinique Ambroise Paré | Neuilly-sur-Seine | 92200 | France |
| Polyclinique Les Fleurs | Ollioules | 83192 | France |
| Hôpital Lariboisière | Paris | 75475 | France |
| Hôpital Saint Joseph | Paris | 75674 | France |
| CH de Pau | Pau | 64046 | France |
| Clinique La Croix du Sud | Quint-Fonsegrives | 31130 | France |
| Polyclinique Saint Laurent | Rennes | 35700 | France |
| Centre Cardiologique du Nord | Saint-Denis | 93200 | France |
| Clinique Rhéna / GERC | Strasbourg | 67000 | France |
| Nouvel Hopital Civil | Strasbourg | 67100 | France |
| CH de Toulon | Toulon | 83056 | France |
| CH de Tourcoing | Tourcoing | 59200 | France |
| CHRU de Tours | Tours | 37044 | France |
| Clinique Saint Joseph | Trélazé | 49800 | France |
| CH de Valence | Valence | 26000 | France |
| Polyclinique Vauban | Valenciennes | 59300 | France |
| CH de Vannes | Vannes | 56017 | France |
| Médpôle Lyon Villeurbanne | Villeurbanne | 69100 | France |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided