BIOFLOW-SV All Comers Registry (BIOFLOW-SV)

BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels

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.

Study Overview

• Status: Terminated
• Conditions: Restenoses, Coronary; de Novo; Symptomatic Ischemic Heart Disease
• Intervention / Treatment: Device: Orsiro Sirolimus Eluting Coronary Stent System

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 Type: Observational
• Enrollment (Actual): 261

Contacts and Locations

Study Locations

• Brazil
  • Porto Alegre, Brazil, 90560-030
    • Moinhos de Vento Hospital
  • São José do Rio Preto, Brazil
    • Hospital de Base

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This registry will include subjects requiring a treatment of coronary artery disease with an Orsiro DES.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLF for the overall cohort	TLF at 12 months post procedure for the overall cohort	at 12 months
Clinically driven Target Lesion Revascularization (TLR)	Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure	at 6 and 12 months
Clinically driven Target Vessel Revascularization (TVR)	Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure	at 6 and 12 months
Definite and probable stent thrombosis	Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)	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	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	12 months

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Marco Weinstain, MD, Moinhos de Vento Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): October 6, 2021

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Stenosis; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Restenosis; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: C1607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No