Coronary Artery DiseasesNCT02273648
BIOTRONIK - BIOFLOW-III Registry French Satellite
An observational study of Coronary Artery Diseases, run by Biotronik France at 50 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Diseases
- What is being tested?
- Drug Eluting Stent (DES)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 50 sitesFrance
- Study dates
- 19 Nov 2014to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
France50 sites
CH d'Aix en Provence
Aix-en-Provence
Clinique de l'Europe
Amiens
Centre Hospitalier d'Antibes
Antibes
Clinique Rhône Durance
Avignon
Hopital Henri Duffaut
Avignon
Centre Hospitalier de Bastia
Bastia
Clinique la fourcade
Bayonne
Clinique St Augustin, Service Cardiologie Interventionnelle
Bordeaux
Clinique Convert, Cardiologie Interventionnelle
Bourg-en-Bresse
Clinique Keraudren
Brest
HP St Martin, Service de Cardiologie
Caen
CHU de Clermont Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand
CH Sud Francilien
Corbeil
Clinique Louis Pasteur
Essey-lès-Nancy
CHU Fort de France
Fort-de-France, 97490
Groupe Hospitalier Mutualiste
Grenoble
CHU Point-à-Pitre
La Guadeloupe
Centre Hospitalier de la Roche-sur-Yon
La Roche-sur-Yon
CH La Rochelle
La Rochelle
CH de Versailles
Le Chesnay
Hôpital Louis Pasteur
Le Coudray
Hôpital privé de l'Estuaire
Le Havre
CHRU de Lille
Lille
Lyon Saint Joseph Saint Luc
Lyon
CHU de la Timone
Marseille
Hôpital Nord de Marseille, Service de Cardiologie
Marseille
Clinique les Fontaines
Melun
Centre Hospitalier Annecy
Metz-Tessy
Clinique Pont de Chaume
Montauban
Montpellier le Millenaire
Montpellier
Clinique du Diaconat Fonderie
Mulhouse
CHU de Nantes
Nantes
Nouvelles Cliniques Nantaises
Nantes
CHU Nimes
Nîmes
Polyclinique les Fleurs
Ollioules
Centre Hospitalier de Pau
Pau
Hôpital Privé St Martin
Pessac
Hôpital privé Claude Galien
Quincy
Clinique Saint Hilaire
Rouen
Centre Hospitalier St Brieuc
Saint-Brieuc
Centre Cardiologique du Nord (CCN)
Saint-Denis
CHU Reunion
Saint-Denis
Clinique Ste Clotilde
Sainte-Clotilde, 97492
Clinique de l'Orangerie
Strasbourg
Nouvel Hôpital Civil
Strasbourg
CHU Toulouse Rangueil
Toulouse
Clinique St Gatien
Tours
Clinique St Joseph
Trélazé
CH de Valence
Valence
CHIV de Villeneuve St Georges
Villeneuve-Saint-Georges
About this study
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
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.
- Conditions
- Coronary Artery Diseases
- Being tested
- Drug Eluting Stent (DES)
- 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
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Ischemia, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting Stent (DES)Device
Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Drug Eluting Stent (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (6)
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).
Measured: 6, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR)
Any repeat revascularization of the target vessel. (Vascular bypass or angioplasty)
Measured: 6, 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
Target Lesion Revascularization (Vascular bypass or angioplasty)
Measured: 6, 12, 24, 36, 48 and 60 months
Stent Thrombosis
Definite, Probable and Possible Stent Thrombosis
Measured: 6, 12, 24, 36, 48 and 60 months
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.
Measured: up to 1 day
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.
Measured: up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start19 Nov 2014
- Primary completionSep 2017
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas CANOT, Study director, Biotronik France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273648
- Sponsor's protocol ID
- G1401 French Satellite
- Status last verified
- Sep 2017
- First submitted
- 22 Oct 2014
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02273648
- Acronym / sponsor ID
- G1401 French Satellite
- Conditions
- Coronary Artery Diseases
- Keywords
- national, multicenter, observational registry, Orsiro Drug Eluting Stent, Stenting Treatment of coronary artery disease, coronary revascularization, PCI, STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Biotronik FranceIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orsiro | – | Device: Drug Eluting Stent (DES)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Eluting Stent (DES)Percutaneous Coronary Intervention | Device | Orsiro |
Primary outcome
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)
6 secondary outcomes
TLF
Time frame: 6, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR)
Time frame: 6, 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
Time frame: 6, 12, 24, 36, 48 and 60 months
Stent Thrombosis
Time frame: 6, 12, 24, 36, 48 and 60 months
Clinical Device Success
Time frame: up to 1 day
Clinical Procedural Success
Time frame: up to seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas CANOT study director
Biotronik France
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Diseases, run by Biotronik France at 50 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.