Coronary Artery DiseaseNCT06657326
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
A study testing BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent and BioFreedom™ stainless steel Biolimus A9™-coated stent in people with Coronary Artery Disease and Chronic Stable Angina, run by Biosensors Europe SA at 6 sites in Malaysia.
Trial summary
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina
- What is being tested?
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent and BioFreedom™ stainless steel Biolimus A9™-coated stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 6 sitesMalaysia
- Study dates
- 18 Dec 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis >70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).
- Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
Who cannot join
- Pregnant and breastfeeding women
- Age <18 years old
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Patients expected not to comply with 1 month DAPT
- Active bleeding at the time of inclusion
- Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only)
Show all 20Show fewer
- Number of target lesions >2
- Patient requires a stent of diameter <2.25mm
- Patient requires a stent of diameter >4.0mm
- Isolated ostial lesions within 3 mm of the origin of LAD or LCx (left main lesions involving the ostia of the LAD and/or LCx are eligible)
- Patient has known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary)
- Patient with chronic total occlusion(s) as target lesion(s)
- Severe calcification that might prevent sufficient expansion of the DES, unless pre-treated with a plaque modification device such as cutting balloon, scoring balloon or intravascular lithotripsy.
- Note: Use of rotational or orbital atherectomy is also permitted.
- Cardiogenic shock
- Compliance with long-term single anti-platelet therapy unlikely
- Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
- Any PCI during the previous 12 months
- Participation in another clinical study (12 months after index procedure)
- Patients with a life expectancy of <12 months
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Malaysia6 sites, 6 recruiting
- Recruiting
Hospital Raja Permaisuri Bainun
Ipoh, Perak
Nor Hanim Bt. Mohd Amin, Dr., norhanim.mohdamin@yahoo.com
- Recruiting
Hospital Sultanah Aminah
Johor Bahru, Johor
Gurudevan a/l Mahadevan, Dr., mguru3579@yahoo.com
- Recruiting
Hospital Serdang
Kajang, Selangor
Kamaraj a/l Selvaraj, Dr., kamarajdoc@gmail.com
- Recruiting
Hospital Queen Elizabeth II
Kota Kinabalu, Sabah
Liew Houng Bang, Dr., hbliew22@gmail.com
- Recruiting
Pusat Jantung Hospital Umum Sarawak
Kota Kinabalu, Sarawak
Ong Tiong Kiam, Dr., ongtk@outlook.com
- Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, Pahang
Anwar Irawan Bin Ruhani, Dr., anwarruhani@gmail.com
About this study
Official title: Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.
Read the detailed description
The LEADERS FREE IV trial is conducted to evaluate of the efficacy (QCA) and safety of the BioFreedom™ Ultra Drug Coated Stent in patients with High Bleeding Risk (HBR) and coronary artery disease undergoing Percutaneous Coronary Intervention.
It is a prospective, multi-center, single blind (to patient), randomized, comparator trial, designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia.
The primary objective is to confirm non-inferiority of the BioFreedom™ Ultra stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary objective is to assess safety as measured by TLF and ST. 444 patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed up to 5 years to measure for late TLF and ST events.
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia, Acute Coronary Syndrome
- Being tested
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Angina, Unstable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stentDevice
Stent implantation
BioFreedom™ stainless steel Biolimus A9™-coated stentDevice
Stent implantation
| Study group | Role | What they receive |
|---|---|---|
| BioFreedom™ Ultra DCS | Experimental | Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ Ultra stent if randomized to this arm (1:1 ratio) Receives: Device: BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent |
| BioFreedom™ DCS | Active comparator | Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ stent if randomized to this arm (1:1 ratio) Receives: Device: BioFreedom™ stainless steel Biolimus A9™-coated 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 (1)
All clinical events at protocol defined timepoints
- Cardiovascular Death
- Myocardial infarction (according to the Fourth Universal Definition)
- TLF (defined as cardiovascular death, target vessel related MI and clinically driven (cd) target lesion revascularization (TLR))
- All-cause mortality
- Clinically driven TVR
- Stent Thrombosis, per ARC-2 definition of definite/probable
- Device success
- Procedure success
- Lesion success
- Bleeding per BARC criteria
- BARC 3 to 5
- All BARC
- By vascular access site (Femoral/Radial)
Measured: 1,6,9,12 months, 2 ,3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start18 Dec 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2030 (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
- Patient will be randomized to one of the treatment arms to receive either the BioFreedom™ Ultra DCS or BioFreedom™ DCS
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kamaraj a/l Selvaraj, Dr., Principal investigator, Hospital Serdang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657326
- Sponsor's protocol ID
- 24-AP-01
- Status last verified
- Jun 2025
- First submitted
- 23 Oct 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data relating to the study might be made available to third parties provided the data are treated confidential and that the patient's privacy is guaranteed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. 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™ Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06657326
- Acronym / sponsor ID
- 24-AP-01
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Oct 2024 (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™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.
Detailed description
The LEADERS FREE IV trial is conducted to evaluate of the efficacy (QCA) and safety of the BioFreedom™ Ultra Drug Coated Stent in patients with High Bleeding Risk (HBR) and coronary artery disease undergoing Percutaneous Coronary Intervention.
It is a prospective, multi-center, single blind (to patient), randomized, comparator trial, designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia.
The primary objective is to confirm non-inferiority of the BioFreedom™ Ultra stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary objective is to assess safety as measured by TLF and ST. 444 patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed up to 5 years to measure for late TLF and ST events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patient will be randomized to one of the treatment arms to receive either the BioFreedom™ Ultra DCS or BioFreedom™ DCS
| Arm | Type | Receives |
|---|---|---|
| BioFreedom™ Ultra DCS | Experimental | Device: BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stentCoronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ Ultra stent if randomized to this arm (1:1 ratio) |
| BioFreedom™ DCS | Active comparator | Device: BioFreedom™ stainless steel Biolimus A9™-coated stentCoronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ stent if randomized to this arm (1:1 ratio) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis >70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).
- Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
Key exclusion criteria (20 listed)
- Pregnant and breastfeeding women
- Age <18 years old
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Patients expected not to comply with 1 month DAPT
- Active bleeding at the time of inclusion
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™ Ultra cobalt-chromium Biolimus A9™-coated stentStent implantation | Device | BioFreedom™ Ultra DCS |
| BioFreedom™ stainless steel Biolimus A9™-coated stentStent implantation | Device | BioFreedom™ DCS |
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
1 secondary outcome
All clinical events at protocol defined timepoints
Time frame: 1,6,9,12 months, 2 ,3, 4, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No. Data relating to the study might be made available to third parties provided the data are treated confidential and that the patient's privacy is guaranteed.
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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.
Kamaraj a/l Selvaraj, Dr. principal investigator
Hospital Serdang
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent and BioFreedom™ stainless steel Biolimus A9™-coated stent in people with Coronary Artery Disease and Chronic Stable Angina, run by Biosensors Europe SA at 6 sites in Malaysia.
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 2 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kar Imm Ang, MSc. (+65 6213 0142, ki.ang@biosensors.com), or a site near the patient. 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 5 Jun 2025.