- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03600961
BIOFLOW-SV Portugal Registry (BIOFLOW-SV)
February 14, 2024 updated by: Biotronik AG
BIOTRONIK - SaFety and Performance Registry for an Allcomers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels - Portugal Registry
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
Intervention / Treatment
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)
173
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephanie Sauter, Dr.
- Phone Number: +41 44 864 55 75
- Email: stephanie.sauter@biotronik.com
Study Locations
-
-
-
Carnaxide, Portugal, 2799-134
- Hospital de Santa Cruz
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Carnaxide, Portugal
- Hospital Da Luz
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Leiria, Portugal, 2410-197
- Centro Hospitaler de Leiria E.P.E.
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Évora, Portugal
- Hospital Espirito Santo Evora
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Lesion Failure for the small vessel group
Time Frame: 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)
|
at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TLF for the overall cohort
Time Frame: at 12 months
|
TLF at 12 months post procedure for the overall cohort
|
at 12 months
|
Clinically driven Target Lesion Revascularization (TLR)
Time Frame: at 6 and 12 months
|
Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure
|
at 6 and 12 months
|
Clinically driven Target Vessel Revascularization (TVR)
Time Frame: at 6 and 12 months
|
Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure
|
at 6 and 12 months
|
Definite and probable stent thrombosis
Time Frame: at 6 and 12 months
|
Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)
|
at 6 and 12 months
|
Procedure success
Time Frame: 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
|
12 months
|
Device success
Time Frame: 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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pedro Braga, MD, Centro Hospitalar de Vila Nova de Gaia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2018
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
December 21, 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 (Actual)
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
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- 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
- C1704
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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