BIOTRONIK - BIOFLOW-III Registry French Satellite

Coronary Artery Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02273648
• Other study ID #: G1401 French Satellite
• Status: Active, not recruiting
• Phase: N/A
• First received: October 22, 2014
• Last updated: December 12, 2017
• Start date: November 19, 2014
• Est. completion date: September 2021

Study information

• Verified date: September 2017
• Source: Biotronik France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: September 2021
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Drug Eluting Stent (DES)
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
France	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-les-Nancy
France	CHU Fort de France	Fort-de-France
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	Nimes
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	CHU Reunion	Saint-Denis
France	Clinique Ste Clotilde	Sainte-Clotilde
France	Centre Hospitalier St Brieuc	St Brieuc
France	Centre Cardiologique du Nord (CCN)	St Denis
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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TLF	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).	6, 24, 36, 48 and 60 months
Secondary	Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel. (Vascular bypass or angioplasty)	6, 12, 24, 36, 48 and 60 months
Secondary	Target Lesion Revascularization (TLR)	Target Lesion Revascularization (Vascular bypass or angioplasty)	6, 12, 24, 36, 48 and 60 months
Secondary	Stent Thrombosis	Definite, Probable and Possible Stent Thrombosis	6, 12, 24, 36, 48 and 60 months
Secondary	Clinical Device Success	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.	up to 1 day
Secondary	Clinical Procedural Success	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.	up to seven days