BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Biotronik AG
- Enrollment
- 261
- Locations
- 2
- Primary Endpoint
- Target Lesion Failure for the small vessel group
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Target Lesion Failure for the small vessel group
Time Frame: 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 Outcomes
- Clinically driven Target Lesion Revascularization (TLR)(at 6 and 12 months)
- Clinically driven Target Vessel Revascularization (TVR)(at 6 and 12 months)
- TLF for the overall cohort(at 12 months)
- Procedure success(12 months)
- Device success(12 months)
- Definite and probable stent thrombosis(at 6 and 12 months)