BIOFLOW-III Belgium Satellite Registry
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ClinicalTrials.gov Identifier: NCT01831336 |
Recruitment Status
:
Completed
First Posted
: April 15, 2013
Last Update Posted
: September 28, 2017
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Condition or disease |
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Coronary Artery Disease Myocardial Ischemia |
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil 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%-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%-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 immobilised 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 a 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. This observational registry 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 Type : | Observational |
Actual Enrollment : | 332 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 Belgium |
Actual Study Start Date : | February 2013 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |
Group/Cohort |
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Orsiro DES |
- Target Lesion Failure (TLF) [ Time Frame: 12 months ]Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
- Target Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ]Any repeat revascularization of the target vessel.
- Target Lesion Revascularization (TLR) [ Time Frame: 6 and 12 months ]Any repeat revascularization of the target lesion.
- Stent Thrombosis [ Time Frame: 6 and 12 months ]Definite, Probable and Possible Stent Thrombosis
- Clinical Device Success [ Time Frame: At time of intervention ]Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents) 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. Standard predilation catheters and post-dilation catheters (if applicable) may be used.
- Clinical Procedural Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ]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.
- Target Lesion Failure (TLF) [ Time Frame: 6 months ]Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not reached yet.

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 ClinicalTrials.gov identifier (NCT number): NCT01831336
Belgium | |
Brussels Heart Center | |
Brussels, Belgium | |
UCL St. Luc | |
Bruxelles, Belgium, 1200 | |
CHU Charleroi | |
Charleroi, Belgium | |
Grand Hopital de Charleroi Saint Joseph | |
Gilly, Belgium | |
CHR de la Citadelle | |
Liège, Belgium | |
CHU Liège | |
Liège, Belgium | |
Brussels Heart Center St Pierre | |
Ottignies, Belgium | |
UCL de Mont Godine | |
Yvoir, Belgium |
Principal Investigator: | Victor Legrand, Prof. Dr. | CHU Liege (Hospitalo-Facultaire Universitaire de Liège) |
Responsible Party: | Biotronik Belgium NV |
ClinicalTrials.gov Identifier: | NCT01831336 History of Changes |
Other Study ID Numbers: |
G1215 |
First Posted: | April 15, 2013 Key Record Dates |
Last Update Posted: | September 28, 2017 |
Last Verified: | September 2017 |
Keywords provided by Biotronik Belgium NV:
International Multicenter Observational registry Orsiro Drug Eluting Stent (DES) Stenting Treatment of Coronary Artery Disease Coronary revascularization Percutaneous Coronary Intervention STEMI |
NSTEMI Ischemia Angina Subgroups Acute Myocardial Infarction Diabetes Small Vessels Chronic Total Occlusion (CTO) |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |