de Novo, Restenoses, Coronary, Symptomatic Ischemic Heart Disease
Conditions
Brief summary
Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm.
Detailed description
Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.
Interventions
Percutaneous coronary intervention
Sponsors
Biotronik AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects ≥18 years of Age * Subject must sign a Patient Informed Consent (PIC) * Subject must agree to undergo all required follow-up visits, either at the hospital or by phone. * Subject with coronary artery disease requiring treatment with Orsiro Sirolimus eluting stent system
Exclusion criteria
* Pregnant and/or breast feeding females at the time of enrolment * Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated * Currently participating in another study that has not yet reached the primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure for the small vessel group | 12 months | Primary endpoint will be Target Lesion Failure (TLF) at 12 months for the small vessels group, defined as a composite of cardiac death, target vessel Myocardial Infarction (MI) or clinically driven Target Lesion Revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically driven Target Lesion Revascularization (TLR) | at 6 and 12 months | Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure |
| Clinically driven Target Vessel Revascularization (TVR) | at 6 and 12 months | Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure |
| TLF for the overall cohort | at 12 months | TLF at 12 months post procedure for the overall cohort |
| Procedure success | 12 months | defined as achievement of a final diameter stenosis of \<30% by investigator's visual estimate (using any percutaneous method) without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay |
| Device success | 12 months | defined as a final residual diameter stenosis of \<30% by investigator's visual estimate, using the assigned device only, successful delivery of the stent to the target lesion site in the coronary artery, appropriate stent deployment, and successful removal of the device. Post-dilatation is allowed to achieve device success |
| Definite and probable stent thrombosis | at 6 and 12 months | Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition) |
Countries
Brazil
Outcome results
None listed