Coronary Arterial Disease (CAD)NCT06669793
Biolimus-Coated Balloon in de Novo Large Vessel Coronary Lesions
A study testing biolimus-coated balloon and paclitaxel-coated balloon in people with Coronary Arterial Disease (CAD), run by Xuzhou Third People's Hospital.
Trial summary
Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- biolimus-coated balloon and paclitaxel-coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2024to 23 May 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiography inclusion criteria
- angiographically confirmed de novo coronary artery lesion;
- target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
- target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);
- either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;
- successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria
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- subjects at the age between ≥18 and ≤80 years old;
- patients with symptoms or evidence of myocardial ischaemia;
- subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation and at 30 days, 6 months, 9 months and 12 months after operation.
Who cannot join
- Radiography exclusion criteria
- in-stent lesions;
- For the left main disease, true bifurcation lesion, chronic total occlusive lesions;
- Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation;
- Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria
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- Any patient with myocardial infarction within one month;
- Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;
- Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
- Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
- Patients with severe renal failure(eGFR<30ml/minute) or such medical history, failure to comply with angiography conditions;
- Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
- Patients who plans to accept selective operation within 1 year;
- Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
- Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Trial Comparing the Biolimus-coated Balloon and Paclitaxel-coated Balloon in de Novo Large Vessel Coronary Lesions
Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Currently, even with the most advanced design concepts of drug-eluting stents (DES), the permanent foreign body and in-stent restenosis after implantation are still very detrimental to the clinical outcomes of patients. These problems have been mitigated to some extent by the advent of the drug-coated balloon (DCB), a special balloon coated with an antiproliferative drug that is uniformly delivered to the vessel wall during endovascular dilatation to inhibit endothelial proliferation.
This study is a prospective randomized study of a novel drug-coated balloon for the treatment of de novo coronary artery large vessel lesions. By comparing the clinical outcomes of the novel BA9 drug-coated balloon (BCB) with those of the paclitaxel-coated balloon (PCB) in the treatment of de novo coronary artery large vessel, we evaluated the safety and efficacy of the BCB for such lesions, and provided evidence for the later use of rapamycin-based drug-coated balloons in PCI.
They are randomly dividing them into BCB treatment group and PCB treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- biolimus-coated balloon, paclitaxel-coated balloon
- Keywords
- paclitaxel-coated balloon, biolimus-coated balloon, de novo lesions, large coronary artery vessel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biolimus-coated balloonDevice
Also called BA9 balloon
238 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Biolimus-coated balloon.
paclitaxel-coated balloonDevice
237 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of paclitaxel-coated balloon.
| Study group | Role | What they receive |
|---|---|---|
| biolimus-coated balloon group | Experimental | Not described Receives: Device: biolimus-coated balloon |
| paclitaxel-coated balloon group | Experimental | Not described Receives: Device: paclitaxel-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
include cardiac death, non-fatal myocardial infarction, and target lesion revascularization.
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 posted1 Nov 2024
- Study start10 Dec 2024 (estimated)
- Primary completion23 May 2027 (estimated)
- Study completion23 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669793
- Sponsor's protocol ID
- 2024-02-008-H01
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Biolimus-coated Balloon and Paclitaxel-coated Balloon in de Novo Large Vessel Coronary Lesions
- ClinicalTrials.gov ID
- NCT06669793
- Acronym / sponsor ID
- 2024-02-008-H01
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- paclitaxel-coated balloon, biolimus-coated balloon, de novo lesions, large coronary artery vessel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Xuzhou Third People's HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 23 May 2027 (estimated)
- Study completion
- 23 May 2028 (estimated)
- First posted
- 1 Nov 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.
Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Currently, even with the most advanced design concepts of drug-eluting stents (DES), the permanent foreign body and in-stent restenosis after implantation are still very detrimental to the clinical outcomes of patients. These problems have been mitigated to some extent by the advent of the drug-coated balloon (DCB), a special balloon coated with an antiproliferative drug that is uniformly delivered to the vessel wall during endovascular dilatation to inhibit endothelial proliferation.
This study is a prospective randomized study of a novel drug-coated balloon for the treatment of de novo coronary artery large vessel lesions. By comparing the clinical outcomes of the novel BA9 drug-coated balloon (BCB) with those of the paclitaxel-coated balloon (PCB) in the treatment of de novo coronary artery large vessel, we evaluated the safety and efficacy of the BCB for such lesions, and provided evidence for the later use of rapamycin-based drug-coated balloons in PCI.
They are randomly dividing them into BCB treatment group and PCB treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biolimus-coated balloon group | Experimental | Device: biolimus-coated balloon |
| paclitaxel-coated balloon group | Experimental | Device: paclitaxel-coated balloon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Radiography inclusion criteria
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Key exclusion criteria (15 listed)
- Radiography exclusion criteria
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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 |
|---|---|---|
| biolimus-coated balloonAlso: BA9 balloon238 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Biolimus-coated balloon. | Device | biolimus-coated balloon group |
| paclitaxel-coated balloon237 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of paclitaxel-coated balloon. | Device | paclitaxel-coated balloon group |
Primary outcome
major adverse cardiovascular events
Time frame: 12 months
include cardiac death, non-fatal myocardial infarction, and target lesion revascularization.
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 1 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing biolimus-coated balloon and paclitaxel-coated balloon in people with Coronary Arterial Disease (CAD), run by Xuzhou Third People's Hospital.
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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 yaojun zhang, Ph.D. (0516-85786383, mts0207@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (time frame: 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 1 Nov 2024.