Ischemic Heart DiseaseBIOFLOW-SVNCT03600961
BIOFLOW-SV Portugal Registry
An observational study of Ischemic Heart Disease, run by Biotronik AG at 4 sites in Portugal.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Orsiro Sirolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 173 participants
- Where
- 4 sitesPortugal
- Study dates
- 5 Jul 2018to 21 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This registry will include subjects requiring a treatment of coronary artery disease with an Orsiro DES
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Portugal4 sites
Hospital de Santa Cruz
Carnaxide, 2799-134
Hospital da Luz
Carnaxide
Hospital Espirito Santo Evora
Evora
Centro Hospitaler de Leiria E.P.E.
Leiria, 2410-197
About this study
Official title: 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
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Orsiro Sirolimus Eluting Coronary Stent System
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orsiro Sirolimus Eluting Coronary Stent SystemDevice
Percutaneous coronary intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 12 months
Secondary outcomes (6)
TLF for the overall cohort
TLF at 12 months post procedure for the overall cohort
Measured: at 12 months
Clinically driven Target Lesion Revascularization (TLR)
Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure
Measured: at 6 and 12 months
Clinically driven Target Vessel Revascularization (TVR)
Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure
Measured: at 6 and 12 months
Definite and probable stent thrombosis
Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start5 Jul 2018
- Primary completion30 Dec 2020
- Study completion21 Dec 2021
Why it stopped: Problem with enrollment due to Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Braga, MD, Principal investigator, Centro Hospitalar de Vila Nova de Gaia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600961
- Sponsor's protocol ID
- C1704
- Acronym
- BIOFLOW-SV
- Status last verified
- Feb 2024
- First submitted
- 17 Jul 2018
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03600961
- Acronym / sponsor ID
- BIOFLOW-SV / C1704
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Problem with enrollment due to Covid-19
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This registry will include subjects requiring a treatment of coronary artery disease with an Orsiro DES
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orsiro Sirolimus Eluting Coronary Stent SystemPercutaneous coronary intervention | Device | – |
Primary outcome
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)
6 secondary outcomes
TLF for the overall cohort
Time frame: at 12 months
Clinically driven Target Lesion Revascularization (TLR)
Time frame: at 6 and 12 months
Clinically driven Target Vessel Revascularization (TVR)
Time frame: at 6 and 12 months
Definite and probable stent thrombosis
Time frame: at 6 and 12 months
Procedure success
Time frame: 12 months
Device success
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Problem with enrollment due to Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Braga, MD principal investigator
Centro Hospitalar de Vila Nova de Gaia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Biotronik AG at 4 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problem with enrollment due to Covid-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure for the small vessel group (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.