BIOFLOW-SV All Comers Registry

Biotronik AG261 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

261

Conditions

de Novo Symptomatic Ischemic Heart Disease Restenoses, Coronary

Interventions

Orsiro Sirolimus Eluting Coronary Stent SystemDEVICE

Percutaneous coronary intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Moinhos de Vento Hospital

Porto Alegre, Brazil

Hospital de Base

São José do Rio Preto, Brazil

Outcomes

Primary Outcomes

Target Lesion Failure for the small vessel group

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)

Time frame: 12 months

Secondary Outcomes

TLF for the overall cohort

TLF at 12 months post procedure for the overall cohort

Time frame: at 12 months

Clinically driven Target Lesion Revascularization (TLR)

Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure

Time frame: at 6 and 12 months

Clinically driven Target Vessel Revascularization (TVR)

Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure

Time frame: at 6 and 12 months

Definite and probable stent thrombosis

Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)

Time frame: at 6 and 12 months

Procedure success

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

Time frame: 12 months

Device success

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

Data from ClinicalTrials.gov

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