BIOTRONIK - BIOFLOW-III Registry French Satellite
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
1 other identifier
observational
1,000
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Longer than P75 for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedStudy Start
First participant enrolled
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedDecember 14, 2017
September 1, 2017
2.8 years
October 22, 2014
December 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Lesion Failure (TLF)
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)
12 months
Secondary Outcomes (6)
TLF
6, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR)
6, 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
6, 12, 24, 36, 48 and 60 months
Stent Thrombosis
6, 12, 24, 36, 48 and 60 months
Clinical Device Success
up to 1 day
- +1 more secondary outcomes
Study Arms (1)
Orsiro
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
Interventions
Eligibility Criteria
All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik Francelead
Study Sites (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
Centre Hospitalier de Bastia
Bastia, France
Clinique la fourcade
Bayonne, France
Clinique St Augustin, Service Cardiologie Interventionnelle
Bordeaux, France
Clinique Convert, Cardiologie Interventionnelle
Bourg-en-Bresse, France
Clinique Keraudren
Brest, France
HP St Martin, Service de Cardiologie
Caen, France
CHU de Clermont Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand, France
CH Sud Francilien
Corbeil, France
Clinique Louis Pasteur
Essey-lès-Nancy, France
CHU Fort de France
Fort-de-France, 97490, France
Groupe Hospitalier Mutualiste
Grenoble, France
CHU Point-à-Pitre
La Guadeloupe, France
Centre Hospitalier de la Roche-sur-Yon
La Roche-sur-Yon, France
CH La Rochelle
La Rochelle, France
CH de Versailles
Le Chesnay, France
Hôpital Louis Pasteur
Le Coudray, France
Hôpital privé de l'Estuaire
Le Havre, France
CHRU de Lille
Lille, France
Lyon Saint Joseph Saint Luc
Lyon, France
CHU de la Timone
Marseille, France
Hôpital Nord de Marseille, Service de Cardiologie
Marseille, France
Clinique les Fontaines
Melun, France
Centre Hospitalier Annecy
Metz-Tessy, France
Clinique Pont de Chaume
Montauban, France
Montpellier le Millenaire
Montpellier, France
Clinique du Diaconat Fonderie
Mulhouse, France
CHU de Nantes
Nantes, France
Nouvelles Cliniques Nantaises
Nantes, France
CHU Nimes
Nîmes, France
Polyclinique les Fleurs
Ollioules, France
Centre Hospitalier de Pau
Pau, France
Hôpital Privé St Martin
Pessac, France
Hôpital privé Claude Galien
Quincy, France
Clinique Saint Hilaire
Rouen, France
Centre Hospitalier St Brieuc
Saint-Brieuc, France
Centre Cardiologique du Nord (CCN)
Saint-Denis, France
CHU Reunion
Saint-Denis, France
Clinique Ste Clotilde
Sainte-Clotilde, 97492, France
Clinique de l'Orangerie
Strasbourg, France
Nouvel Hôpital Civil
Strasbourg, France
CHU Toulouse Rangueil
Toulouse, France
Clinique St Gatien
Tours, France
Clinique St Joseph
Trélazé, France
CH de Valence
Valence, France
CHIV de Villeneuve St Georges
Villeneuve-Saint-Georges, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicolas CANOT
Biotronik France
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
October 24, 2014
Study Start
November 19, 2014
Primary Completion
September 1, 2017
Study Completion
September 1, 2021
Last Updated
December 14, 2017
Record last verified: 2017-09