Coronary Artery Diseases
Conditions
Keywords
International, Multicenter, Observational registry, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of coronary artery disease, Coronary revascularization, Percutaneous Coronary Intervention (PCI), STEMI, NSTEMI, Ischemia, Angina, Acute Myocardial Infarction (AMI), Small Vessels, Chronic Total Occlusion (CTO)
Brief summary
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).
Detailed description
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 neontimal 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. Results will contribute to the collection of clinical evidence for the clinical Performance.
Interventions
None listed
Sponsors
Biotronik Italia S.p.A.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 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
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Revascularization (TVR) | 6, 12 and 18 months | Any repeat revascularization of the target vessel. |
| Target Lesion Revascularization (TLR) | 6, 12 and 18 months | Defined as any repeat revascularization of the target lesion |
| TLF | 6 and 18 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). |
| Clinical device success | Up to discharge | 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. |
| Clinical procedural success | up to seven days | 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. |
| Stent Thrombosis | 6, 12 and 18 months | Definite, Probable and Possible Stent Thrombosis |
Countries
Italy
Outcome results
None listed