BIOFLOW-SV All Comers Registry

Restenoses, Coronary Clinical Trial

— BIOFLOW-SV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03600948
• Other study ID #: C1607
• Status: Terminated
• Start date: August 27, 2018
• Est. completion date: October 6, 2021

Study information

• Verified date: February 2024
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 261
• Est. completion date: October 6, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Restenosis
• de Novo
• Heart Diseases
• Myocardial Ischemia
• Restenoses, Coronary
• Symptomatic Ischemic Heart Disease

Intervention

Device:
• Orsiro Sirolimus Eluting Coronary Stent System
Percutaneous coronary intervention

Locations

Country	Name	City	State
Brazil	Moinhos de Vento Hospital	Porto Alegre
Brazil	Hospital de Base	São José do Rio Preto

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TLF for the overall cohort	TLF at 12 months post procedure for the overall cohort	at 12 months
Secondary	Clinically driven Target Lesion Revascularization (TLR)	Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure	at 6 and 12 months
Secondary	Clinically driven Target Vessel Revascularization (TVR)	Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure	at 6 and 12 months
Secondary	Definite and probable stent thrombosis	Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)	at 6 and 12 months
Secondary	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
Secondary	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