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BIOTRONIK - BIOFLOW-III Registry French Satellite

NCT ID: NCT02273648

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-19

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Coronary Artery Diseases

Keywords

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Drug Eluting Stent (DES)

Intervention Type DEVICE

Percutaneous Coronary Intervention

Interventions

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Drug Eluting Stent (DES)

Percutaneous Coronary Intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas CANOT

Role: STUDY_DIRECTOR

Biotronik France

Locations

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CH d'Aix en Provence

Aix-en-Provence, , France

Site Status

Clinique de l'Europe

Amiens, , France

Site Status

Centre Hospitalier d'Antibes

Antibes, , France

Site Status

Clinique Rhône Durance

Avignon, , France

Site Status

Hopital Henri Duffaut

Avignon, , France

Site Status

Centre Hospitalier de Bastia

Bastia, , France

Site Status

Clinique la fourcade

Bayonne, , France

Site Status

Clinique St Augustin, Service Cardiologie Interventionnelle

Bordeaux, , France

Site Status

Clinique Convert, Cardiologie Interventionnelle

Bourg-en-Bresse, , France

Site Status

Clinique Keraudren

Brest, , France

Site Status

HP St Martin, Service de Cardiologie

Caen, , France

Site Status

CHU de Clermont Ferrand, Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

CH Sud Francilien

Corbeil, , France

Site Status

Clinique Louis Pasteur

Essey-lès-Nancy, , France

Site Status

CHU Fort de France

Fort-de-France, , France

Site Status

Groupe Hospitalier Mutualiste

Grenoble, , France

Site Status

CHU Point-à-Pitre

La Guadeloupe, , France

Site Status

Centre Hospitalier de la Roche-sur-Yon

La Roche-sur-Yon, , France

Site Status

CH La Rochelle

La Rochelle, , France

Site Status

CH de Versailles

Le Chesnay, , France

Site Status

Hôpital Louis Pasteur

Le Coudray, , France

Site Status

Hôpital privé de l'Estuaire

Le Havre, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

Lyon Saint Joseph Saint Luc

Lyon, , France

Site Status

CHU de la Timone

Marseille, , France

Site Status

Hôpital Nord de Marseille, Service de Cardiologie

Marseille, , France

Site Status

Clinique les Fontaines

Melun, , France

Site Status

Centre Hospitalier Annecy

Metz-Tessy, , France

Site Status

Clinique Pont de Chaume

Montauban, , France

Site Status

Montpellier le Millenaire

Montpellier, , France

Site Status

Clinique du Diaconat Fonderie

Mulhouse, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Nouvelles Cliniques Nantaises

Nantes, , France

Site Status

CHU Nimes

Nîmes, , France

Site Status

Polyclinique les Fleurs

Ollioules, , France

Site Status

Centre Hospitalier de Pau

Pau, , France

Site Status

Hôpital Privé St Martin

Pessac, , France

Site Status

Hôpital privé Claude Galien

Quincy, , France

Site Status

Clinique Saint Hilaire

Rouen, , France

Site Status

Centre Hospitalier St Brieuc

Saint-Brieuc, , France

Site Status

Centre Cardiologique du Nord (CCN)

Saint-Denis, , France

Site Status

CHU Reunion

Saint-Denis, , France

Site Status

Clinique Ste Clotilde

Sainte-Clotilde, , France

Site Status

Clinique de l'Orangerie

Strasbourg, , France

Site Status

Nouvel Hôpital Civil

Strasbourg, , France

Site Status

CHU Toulouse Rangueil

Toulouse, , France

Site Status

Clinique St Gatien

Tours, , France

Site Status

Clinique St Joseph

Trélazé, , France

Site Status

CH de Valence

Valence, , France

Site Status

CHIV de Villeneuve St Georges

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

Other Identifiers

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G1401 French Satellite

Identifier Type: -

Identifier Source: org_study_id