Clinical trial NCT02273648: BIOTRONIK - BIOFLOW-III Registry French Satellite
Official title: BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III French Satellite
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Diseases
Keywords: national
multicenter
observational registry
Orsiro Drug Eluting Stent
Stenting Treatment of coronary artery disease
coronary revascularization
PCI
STEMI
NSTEMI
Ischemia
Angina
Acute Myocardial Infarction
Small Vessels
Chronic Total Occlusion
Lead sponsor: Biotronik France
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: TLF
timeFrame: 6, 24, 36, 48 and 60 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Stent Thrombosis
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Clinical Device Success
timeFrame: up to 1 day
measure: Clinical Procedural Success
timeFrame: up to seven days
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CH d'Aix en Provence
city: Amiens
country: France
facility: Clinique de l'Europe
city: Antibes
country: France
facility: Centre Hospitalier d'Antibes
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Avignon
country: France
facility: Hopital Henri Duffaut
city: Bastia
country: France
facility: Centre Hospitalier de Bastia
city: Bayonne
country: France
facility: Clinique la fourcade
city: Bordeaux
country: France
facility: Clinique St Augustin, Service Cardiologie Interventionnelle
city: Bourg-en-Bresse
country: France
facility: Clinique Convert, Cardiologie Interventionnelle
city: Brest
country: France
facility: Clinique Keraudren
city: Caen
country: France
facility: HP St Martin, Service de Cardiologie
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand, Hôpital Gabriel Montpied
city: Corbeil
country: France
facility: CH Sud Francilien
city: Essey-les-Nancy
country: France
facility: Clinique Louis Pasteur
city: Fort-de-France
country: France
facility: CHU Fort de France
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste
city: La Guadeloupe
country: France
facility: CHU Point-à-Pitre
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier de la Roche-sur-Yon
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Chesnay
country: France
facility: CH de Versailles
city: Le Coudray
country: France
facility: Hôpital Louis Pasteur
city: Le Havre
country: France
facility: Hôpital privé de l'Estuaire
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Lyon Saint Joseph Saint Luc
city: Marseille
country: France
facility: CHU de la Timone
city: Marseille
country: France
facility: Hôpital Nord de Marseille, Service de Cardiologie
city: Melun
country: France
facility: Clinique les Fontaines
city: Metz Tessy
country: France
facility: Centre Hospitalier Annecy
city: Montauban
country: France
facility: Clinique Pont de Chaume
city: Montpellier
country: France
facility: Montpellier le Millenaire
city: Mulhouse
country: France
facility: Clinique du Diaconat Fonderie
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nimes
country: France
facility: CHU Nimes
city: Ollioules
country: France
facility: Polyclinique les Fleurs
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Pessac
country: France
facility: Hôpital Privé St Martin
city: Quincy
country: France
facility: Hôpital privé Claude Galien
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint-Denis
country: France
facility: CHU Reunion
city: Sainte-Clotilde
country: France
facility: Clinique Ste Clotilde
city: St Brieuc
country: France
facility: Centre Hospitalier St Brieuc
city: St Denis
country: France
facility: Centre Cardiologique du Nord (CCN)
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Tours
country: France
facility: Clinique St Gatien
city: Trélazé
country: France
facility: Clinique St Joseph
city: Valence
country: France
facility: CH de Valence
city: Villeneuve-Saint-Georges
country: France
facility: CHIV de Villeneuve St Georges
Study officials:
affiliation: Biotronik France
name: Nicolas CANOT
role: STUDY_DIRECTOR
References: