BIOFLOW-SV All Comers Registry

NCT03600948 | Terminated DMC

• 1 other identifier: C1607
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 2

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.

Conditions

de Novo; Symptomatic Ischemic Heart Disease; Restenoses, Coronary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• TLF for the overall cohort

  at 12 months

• Clinically driven Target Lesion Revascularization (TLR)

  at 6 and 12 months

• Clinically driven Target Vessel Revascularization (TVR)

  at 6 and 12 months

• Definite and probable stent thrombosis

  at 6 and 12 months

• Procedure success

  12 months

Interventions

Orsiro Sirolimus Eluting Coronary Stent System DEVICE

Percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (2)

Moinhos de Vento Hospital

Porto Alegre, 90560-030, Brazil

Location

Hospital de Base

São José do Rio Preto, Brazil

Location

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Marco Weinstain, MD

  Moinhos de Vento Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: August 27, 2018
• Primary Completion: August 31, 2020
• Study Completion: October 6, 2021
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)