Coronary Artery Diseases Clinical Trial
Official title:
Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent Within Daily Clinical Practice III-Italy
Verified date | September 2017 |
Source | Biotronik Italia S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).
Status | Completed |
Enrollment | 609 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Symptomatic coronary artery disease - Subject 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 - Pregnancy - Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media - Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained - Currently participating in another study and primary endpoint not reached yet |
Country | Name | City | State |
---|---|---|---|
Italy | Cardiologia Ospedaliera Policlinico Bari | Bari | |
Italy | Cardiologia Universitaria Policlinico Bari | Bari | |
Italy | Clinical Santa Maria | Bari | |
Italy | Ospedale Di Venere | Bari | |
Italy | Policlinico Conzorciale di Bari | Bari | |
Italy | P.O. Cardarelli | Campobasso | |
Italy | Azienda Ospedaliera Pugliese-Ciaccio | Catanzaro | |
Italy | Ospedale F. Veneziale | Isernia | |
Italy | A.O. Ospedale Civile Legnano | Legnano | |
Italy | AO Ospedale Civile Legnano, Fornaroli, Magenta | Magenta | |
Italy | Centro Cardiologico Monzino | Milano | |
Italy | Istituto Clinico Città Studi, Milano | Milano | |
Italy | Clinica Mediterranea | Napoli | |
Italy | Ospedale San Salvatore AORMN | Pesaro | |
Italy | European Hospital | Roma | |
Italy | Ospedale Sant'Anna | San Fermo della Battaglia | Como |
Italy | Casa Sollievo della Sofferenza | San Giovanni Rotondo | |
Italy | Clinical Villa Verde | Taranto |
Lead Sponsor | Collaborator |
---|---|
Biotronik Italia S.p.A. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 12 months | |
Secondary | 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). | 6 and 18 months | |
Secondary | Target Vessel Revascularization (TVR) | Any repeat revascularization of the target vessel. | 6, 12 and 18 months | |
Secondary | Target Lesion Revascularization (TLR) | Defined as any repeat revascularization of the target lesion | 6, 12 and 18 months | |
Secondary | Stent Thrombosis | Definite, Probable and Possible Stent Thrombosis | 6, 12 and 18 months | |
Secondary | 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. | Up to discharge | |
Secondary | Clinical procedural 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 using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event during the hospital stay to a maximum of the first seven days post index procedure. | up to seven days |
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