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BIOTRONIK - BIOFLOW-III Registry French Satellite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02273648
Recruitment Status : Active, not recruiting
First Posted : October 24, 2014
Last Update Posted : December 14, 2017
Information provided by (Responsible Party):
Biotronik France

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.

Condition or disease Intervention/treatment
Coronary Artery Diseases Device: Drug Eluting Stent (DES)

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : November 19, 2014
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment

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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. Target Lesion Revascularization (TLR) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    Target Lesion Revascularization (Vascular bypass or angioplasty)

  4. Stent Thrombosis [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    Definite, Probable and Possible Stent Thrombosis

  5. 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.

  6. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02273648

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Sponsors and Collaborators
Biotronik France
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Study Director: Nicolas CANOT Biotronik France

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Responsible Party: Biotronik France Identifier: NCT02273648    
Other Study ID Numbers: G1401 French Satellite
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: September 2017
Keywords provided by Biotronik France:
observational registry
Orsiro Drug Eluting Stent
Stenting Treatment of coronary artery disease
coronary revascularization
Acute Myocardial Infarction
Small Vessels
Chronic Total Occlusion
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases