BIOFLOW-SV All Comers Registry

Biotronik

Status: Terminated

Conditions: Symptomatic Ischemic Heart Disease; Restenoses, Coronary; de Novo

Treatments: Device: Orsiro Sirolimus Eluting Coronary Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT03600948

C1607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.