BIOTRONIK - BIOFLOW-III Registry French Satellite

December 12, 2017 updated by: Biotronik France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • CH d'Aix en Provence
      • Amiens, France
        • Clinique de l'Europe
      • Antibes, France
        • Centre Hospitalier d'Antibes
      • Avignon, France
        • Clinique Rhône Durance
      • Avignon, France
        • Hôpital Henri Duffaut
      • Bastia, France
        • Centre Hospitalier de Bastia
      • Bayonne, France
        • Clinique La Fourcade
      • Bordeaux, France
        • Clinique St Augustin, Service Cardiologie Interventionnelle
      • Bourg-en-Bresse, France
        • Clinique Convert, Cardiologie Interventionnelle
      • Brest, France
        • Clinique Keraudren
      • Caen, France
        • HP St Martin, Service de Cardiologie
      • Clermont-Ferrand, France
        • CHU de Clermont Ferrand, Hôpital Gabriel Montpied
      • Corbeil, France
        • Ch Sud Francilien
      • Essey-les-Nancy, France
        • Clinique Louis Pasteur
      • Fort-de-France, France, 97490
        • CHU Fort de France
      • Grenoble, France
        • Groupe Hospitalier Mutualiste
      • La Guadeloupe, France
        • CHU Point-à-Pitre
      • La Roche-sur-Yon, France
        • Centre Hospitalier de la Roche-sur-Yon
      • La Rochelle, France
        • CH La Rochelle
      • Le Chesnay, France
        • CH de Versailles
      • Le Coudray, France
        • Hôpital Louis Pasteur
      • Le Havre, France
        • Hopital Prive de l'Estuaire
      • Lille, France
        • CHRU de Lille
      • Lyon, France
        • Lyon Saint Joseph Saint Luc
      • Marseille, France
        • CHU de la Timone
      • Marseille, France
        • Hôpital Nord de Marseille, Service de Cardiologie
      • Melun, France
        • Clinique les Fontaines
      • Metz Tessy, France
        • Centre Hospitalier Annecy
      • Montauban, France
        • Clinique Pont de Chaume
      • Montpellier, France
        • Montpellier le Millenaire
      • Mulhouse, France
        • Clinique du Diaconat Fonderie
      • Nantes, France
        • CHU de Nantes
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Nimes, France
        • CHU Nimes
      • Ollioules, France
        • Polyclinique Les Fleurs
      • Pau, France
        • Centre Hospitalier De Pau
      • Pessac, France
        • Hôpital Privé St Martin
      • Quincy, France
        • Hôpital privé Claude Galien
      • Rouen, France
        • Clinique Saint Hilaire
      • Saint-Denis, France
        • Chu Reunion
      • Sainte-Clotilde, France, 97492
        • Clinique Ste Clotilde
      • St Brieuc, France
        • Centre Hospitalier St Brieuc
      • St Denis, France
        • Centre Cardiologique du Nord (CCN)
      • Strasbourg, France
        • Nouvel Hôpital Civil
      • Strasbourg, France
        • Clinique de l'Orangerie
      • Toulouse, France
        • CHU TOULOUSE Rangueil
      • Tours, France
        • Clinique St Gatien
      • Trélazé, France
        • Clinique St Joseph
      • Valence, France
        • CH de Valence
      • Villeneuve-Saint-Georges, France
        • CHIV de Villeneuve St Georges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: Drug Eluting Stent (DES)
Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 12 months
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik France

Investigators

  • Study Director: Nicolas CANOT, Biotronik France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2014

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (ESTIMATE)

October 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G1401 French Satellite

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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