BIOFLOW-SV Portugal Registry

Terminated

• Conditions: Ischemic Heart Disease

• Registration Number: NCT03600961
• Lead Sponsor: Biotronik AG

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 Timeline

• Study Start: 2018-07-05
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Subject is ≥18 years of age
• Subject must sign a Patient Informed Consent (PIC) or a Patient Data Release Form (PDRF)
• Subject must agree to undergo all required follow-up visits

Exclusion Criteria

• Pregnant and/or breast feeding females at the time of enrolment

• Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure for the small vessel group	at 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 Outcome Measures

Name	Time	Method
TLF for the overall cohort	at 12 months	TLF at 12 months post procedure for the overall cohort
Definite and probable stent thrombosis	at 6 and 12 months	Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)
Procedure success	12 months	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
Device success	12 months	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
Clinically driven Target Vessel Revascularization (TVR)	at 6 and 12 months	Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure
Clinically driven Target Lesion Revascularization (TLR)	at 6 and 12 months	Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure

Trial Locations

Locations (4)

Hospital de Santa Cruz; 🇵🇹 Carnaxide, Portugal

Hospital Espirito Santo Evora; 🇵🇹 Évora, Portugal

Hospital da Luz; 🇵🇹 Carnaxide, Portugal

Centro Hospitaler de Leiria E.P.E.; 🇵🇹 Leiria, Portugal