Coronary Artery DiseaseBraveNCT03769623

A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease

A study testing Biolimus and Powerline in people with Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: Biolimus and Powerline
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 206 participants
Where: 1 siteChina
Study dates: 25 Jun 2019to 6 Apr 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

General exclusion criteria
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;
Patients with cardiogenic shock;
Patients with left ventricular ejection fraction of less than 35%;
Female patients planned for or in pregnancy (or lactation) or male patients planned for impregnation;

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Patients with the expected lifetime of no more than 1 year or potential factors of difficulty in clinical follow-up;
Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint, or reaching the time limit of primary endpoint but less than 3 months;
Patients who plans to accept selective operation within 12 months;
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;
Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months;
Patients with bleeding tendency or coagulation disorders;
Patients who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
Patients with other diseases (for instance, malignant tumor, organ grafting or candidate) or addiction history (such as alcohol, cocaine and heroin);
Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.
Radiography exclusion criteria
Evidence for extensive thrombus within target vessel;
Chronic total occlusion (TIMI Level 0 blood flow before operation);
For the left main disease and/or triple vessel disease and bypass lesion needed to be treated simultaneously, branch vessel diameter shall be ≥ 2.5mm bifurcation lesion;
Lesions within a distance of 3mm from circumflex branch, anterior descending branch and right coronary artery orifice;
After treating other vascular lesions at the same period, there are more than two lesions within the same target vessel needed to be treated;
There are more than 2 non-target lesions needed to be intervened or non-target lesion is not intervened before target lesion;
There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass it;
Target lesion is in-stent restenosis;
After predilation of target lesion, residual stenosis is ≥30% or TIMI blood flow is < Level 3, and/or there is NHBL Level C or above dissection.

Trial locations and contacts

1 site in 1 country.

China1 site

General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016

Other trials in China

About this study

This study is a prospective, multicenter, randomized, blind, parallel and superiority test study. It is planned to select 206 cases of subjects with small coronary artery vessel disease who meet the inclusion/exclusion criteria. They are randomly divide them into Biolimus release coronary balloon catheter treatment group and plain old balloon angioplasty catheter (Powerline) 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. Follow-up with angiography is conducted at 9 months. The late lumen loss in diseased segment at 9 months after operation is the primary endpoint.

Read the detailed description

The study was a prospective, multicenter, randomized, blind, parallel positive control, and superiority test study, 206 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were randomly assigned to the treatment group of Biolimus and Powerline at 1:1. All subjects underwent clinical follow-up at 30 days, 6 months, 9 months, and 12 months after surgery, and angiographic follow-up at 9 months. The primary endpoint was late lumen loss at 9 months.

The study will enroll 206 subjects. The sample size determination process is as follows:

Sample size is calculated according to the primary endpoint, late lumen loss (LLL) in diseased segment at 9 months after operation. Through literature review, a Meta analysis combined 11 randomized and control study shows that the late lumen loss level of control group (POBA) in the treatment of small vessel disease is 0.54mm. Another Meta analysis shows that LLL after PTCA operation is 0.57±0.57mm. Clinical investigators and statisticians, according to literature and clinical practice, suppose that the LLL level of test group (DCB) in this study can be lowered to 0.32mm and the combined standard deviation of LLL of the two groups is estimated to be 0.50mm conservatively.

The calculation formula of sample size for parallel design and superiority test is used. In case of taking 0.025 at singles side for inspection level, taking 80% for power (1-β), and taking 0 for superiority cut-off, conduct random grouping according to the ratio of 1:1, the require sample size of each group is calculated to be 82 cases. Considering the maximum failure rate 20% in angiography follow-up (as well as the early withdrawal and random damage caused by other reasons), the planned total sample size of both groups is 206 cases finally, including 103 cases for test group (DCB) and 103 cases for control group.

Conditions: Coronary Artery Disease
Being tested: Biolimus, Powerline
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BiolimusDevice
103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus
PowerlineDevice
103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline

Study groups in NCT03769623
Study group	Role	What they receive
Biolimus	Experimental	BA9 Drug-eluting Coronary Artery Balloon Catheter Receives: Device: Biolimus
Powerline	Active comparator	Balloon dilated catheter Receives: Device: Powerline

What is being measured

The primary outcome is the main question the study is designed to answer.

The late lumen loss
The late lumen loss in the lesion segment 9 months after surgery
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 20196 Apr 2021

First posted7 Dec 2018
Study start25 Jun 2019
Primary completion20 Feb 2021
Study completion6 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Diameter: 2.0mm, 2.25mm, 2.5mm, 2.75mm Length: 10mm, 15mm, 20mm, 25mm, 30mm
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769623
Sponsor's protocol ID: BIO-RISE CHINA
Acronym: Brave
Status last verified: Aug 2021
First submitted: 5 Dec 2018
Last updated: 22 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Xu K, Fu G, Tong Q, Liu B, Han X, Zhang J, Ma G, Yang Q, Li H, Zhou Y, Jing Q, Li Y, Han Y. Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1219-1226. doi: 10.1016/j.jcin.2022.03.024. Epub 2022 May 25.
PubMed 35738744

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease
ClinicalTrials.gov ID: NCT03769623
Acronym / sponsor ID: Brave / BIO-RISE CHINA
Conditions: Coronary Artery Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: JW Medical Systems LtdIndustry (pharma, biotech, devices)
Study start: 25 Jun 2019 (actual)
Primary completion: 20 Feb 2021 (actual)
Study completion: 6 Apr 2021 (actual)
First posted: 7 Dec 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.

Detailed description

The study will enroll 206 subjects. The sample size determination process is as follows:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Diameter: 2.0mm, 2.25mm, 2.5mm, 2.75mm Length: 10mm, 15mm, 20mm, 25mm, 30mm

Arm	Type	Receives
Biolimus	Experimental	Device: BiolimusBA9 Drug-eluting Coronary Artery Balloon Catheter
Powerline	Active comparator	Device: PowerlineBalloon dilated catheter

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (27 listed)

General exclusion criteria
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;
Patients with cardiogenic shock;
Patients with left ventricular ejection fraction of less than 35%;

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
Biolimus103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus	Device	Biolimus
Powerline103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline	Device	Powerline

Primary outcome

The late lumen loss
Time frame: 9 months
The late lumen loss in the lesion segment 9 months after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Derived from this study: PubMed 35738744Xu K, Fu G, Tong Q, Liu B, Han X, Zhang J, Ma G, Yang Q, Li H, Zhou Y, Jing Q, Li Y, Han Y. Biolimus-Coated Balloon in Small-Vessel Coronary Artery Disease: The BIO-RISE CHINA Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1219-1226. doi: 10.1016/j.jcin.2022.03.024. Epub 2022 May 25.

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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.

Yaling Han principal investigator

The General Hospital of Northern Theater Command

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biolimus and Powerline in people with Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.

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 0 inclusion and 27 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: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The late lumen loss (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769623, which also lists 1 linked publication.

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 22 Sep 2021.