Coronary Artery DiseaseBioFreedomQCANCT03307213
BioFreedom QCA Study in CAD Patients
A study testing BioFreedom™ CoCr Biolimus A9™ stent and BioFreedom™ SS Biolimus A9™ stent in people with Coronary Artery Disease and Cardiac Death, run by Biosensors Europe SA at 2 sites in 2 countries.
Trial summary
This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to efficacy and shows a similar safety profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiac Death, Myocardial Infarction
- What is being tested?
- BioFreedom™ CoCr Biolimus A9™ stent and BioFreedom™ SS Biolimus A9™ stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Jun 2018to 31 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- "Real world, all comer" patients
- Age ≥18 years;
- Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
- Presence of one or more coronary artery stenosis >50% in a native coronary artery or a saphenous bypass graft from 2.50 to 3.5 mm in diameter that can be covered with one or multiple stents (angiographic inclusion);
- No limitation on the number of treated lesions, and vessels, and lesion length
Who cannot join
- Individual is pregnant, nursing or planning to be pregnant;
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus A9™ or contrast material
- Inability to provide informed consent;
- Note: Not all exclusion criteria are listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Biolimus A9™ CoCr Stent in a Randomised Trial in Patients With CAD
This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to efficacy and shows a similar safety profile.
Read the detailed description
The BioFreedom™ QCA trial is designed to evaluate the safety and efficacy of the BioFreedom™ CoCr DCS coronary stent system compared to the Biofreedom™ stainless steel DCS coronary stent system, in a randomized controlled trial on an all-comers patient population.
The primary objective is to measure non-inferiority of the BioFreedom™ CoCr stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary endpoint is to assess safety as measured by MACE and ST. Two hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed-up to 2 years to measure for late MACE and ST events.
- Being tested
- BioFreedom™ CoCr Biolimus A9™ stent, BioFreedom™ SS Biolimus A9™ stent
- Medical subject headings
- Coronary Artery Disease, Death, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFreedom™ CoCr Biolimus A9™ stentDevice
Stent implantation
BioFreedom™ SS Biolimus A9™ stentDevice
Stent implantation
| Study group | Role | What they receive |
|---|---|---|
| BioFreedom™CoCr | Experimental | Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm. Receives: Device: BioFreedom™ CoCr Biolimus A9™ stent |
| BioFreedom™ SS | Active comparator | Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm. Receives: Device: BioFreedom™ SS Biolimus A9™ stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late lumen loss (LLL) at 9 months
In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months
Measured: 9 months
Secondary outcomes (3)
Cardiac Death
Cardiac Death
Measured: 1, 9, 12 and 24 months
Myocardial infarction
Myocardial infarction
Measured: 1, 9, 12 and 24 months
MACE
MACE defined as cardiac death, myocardial infarction and clinically indicated
Measured: 1, 9, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start19 Jun 2018
- Primary completion30 Sep 2019
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manel Sabate, Dr., Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307213
- Sponsor's protocol ID
- 17EU02
- Acronym
- BioFreedomQCA
- Status last verified
- Dec 2019
- First submitted
- 6 Oct 2017
- Last updated
- 24 Dec 2019
- 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 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Biolimus A9™ CoCr Stent in a Randomised Trial in Patients With CAD
- ClinicalTrials.gov ID
- NCT03307213
- Acronym / sponsor ID
- BioFreedomQCA / 17EU02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 11 Oct 2017 (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.
This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to efficacy and shows a similar safety profile.
Detailed description
The BioFreedom™ QCA trial is designed to evaluate the safety and efficacy of the BioFreedom™ CoCr DCS coronary stent system compared to the Biofreedom™ stainless steel DCS coronary stent system, in a randomized controlled trial on an all-comers patient population.
The primary objective is to measure non-inferiority of the BioFreedom™ CoCr stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary endpoint is to assess safety as measured by MACE and ST. Two hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed-up to 2 years to measure for late MACE and ST events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.
| Arm | Type | Receives |
|---|---|---|
| BioFreedom™CoCr | Experimental | Device: BioFreedom™ CoCr Biolimus A9™ stentPatients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm. |
| BioFreedom™ SS | Active comparator | Device: BioFreedom™ SS Biolimus A9™ stentPatients with CAD will receive the BioFreedom™SS stent if randomised to this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- "Real world, all comer" patients
- Age ≥18 years;
- Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
- Presence of one or more coronary artery stenosis >50% in a native coronary artery or a saphenous bypass graft from 2.50 to 3.5 mm in diameter that can be covered with one or multiple stents (angiographic inclusion);
- No limitation on the number of treated lesions, and vessels, and lesion length
Key exclusion criteria (4 listed)
- Individual is pregnant, nursing or planning to be pregnant;
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus A9™ or contrast material
- Inability to provide informed consent;
- Note: Not all exclusion criteria are listed.
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 |
|---|---|---|
| BioFreedom™ CoCr Biolimus A9™ stentStent implantation | Device | BioFreedom™CoCr |
| BioFreedom™ SS Biolimus A9™ stentStent implantation | Device | BioFreedom™ SS |
Primary outcome
In-stent late lumen loss (LLL) at 9 months
Time frame: 9 months
In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months
3 secondary outcomes
Cardiac Death
Time frame: 1, 9, 12 and 24 months
Myocardial infarction
Time frame: 1, 9, 12 and 24 months
MACE
Time frame: 1, 9, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- 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.
Manel Sabate, Dr. principal investigator
Hospital Clinic of Barcelona
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFreedom™ CoCr Biolimus A9™ stent and BioFreedom™ SS Biolimus A9™ stent in people with Coronary Artery Disease and Cardiac Death, run by Biosensors Europe SA at 2 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Spain. 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?
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?
In-stent late lumen loss (LLL) at 9 months (time frame: 9 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 24 Dec 2019.