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Coronary Artery DiseaseDCB-BIFNCT04242134

Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions

A study testing Drug-coating balloon in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Drug-coating balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
784 participants
Where
1 siteChina
Study dates
8 Sep 2020to 30 Jun 2026
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

  • Subject must be age ≥18 years.
  • Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
  • Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed.
  • Subject is willing to comply with all protocol-required follow-up evaluations.
  • Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).
  • Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation.
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  • Target lesion must have visually estimated stenosis ≥50%.
  • Target lesion length of side branch must be <10 mm by visual estimation.
  • Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel.

Who cannot join

  • Patient with STEMI (within 1-week from the onset of chest pain to admission).
  • Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications.
  • Patient is intolerable to dual anti-platelet therapy.
  • Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
  • Patient is pregnant or nursing.
  • Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
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  • Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
  • Restenotic lesion.
  • Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized.
  • Severe calcification needing rotational atherectomy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

Other trials in China

About this study

Official title: Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions

This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.

Read the detailed description

This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments.

All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.

Being tested
Drug-coating balloon
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.

  • Drug-coating balloonDevice

    Also called DCB

    Provisional stenting technique with DCB

Study groups in NCT04242134
Study groupRoleWhat they receive
PS-DCBExperimentalFor PS-DCB group 1. NC balloon dilating ostial side branch (SB) (1:1 ratio). 2. DCB dilating SB. Specifically, the DCB, which had to be 2-3 mm longer on each side than the predilatation balloon, was inflated at nominal pressure for 30~ 60 s. The ratio of the DCB diameter to the nominal diameter of the SB was recommended to be between 0.8 and 1.0. DCB should be delivered to the lesion within 2 min after entering human body. 3. Kissing inflation using 2 noncomplian balloons. 4. Stenting side branch with T and protrusion (TAP) technique if any of the following issues was observed after kissing balloon inflation: >type C dissection or thrombolysis in myocardial infarction (TIMI) flow <3. 5. Final kissing inflation and proximal optimal technique (POT).
Receives: Device: Drug-coating balloon
PS-NCBActive comparatorFor PS-NCB group 1. NC balloon dilating ostial SB (1:1 ratio). 2. Kissing inflation using 2 NC balloons. 3. Stenting side branch with TAP technique if any of the following issues was observed after kissing balloon inflation: >type C dissection or thrombolysis in myocardial infarction (TIMI) flow <3. 4. Final kissing inflation and proximal optimal technique (POT).
Receives: Device: Drug-coating balloon

What is being measured

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

  1. Rate of major adverse cardiac event

    MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.

    Measured: 12 months after angioplasty

Secondary outcomes (4)

  1. Rate of all-cause death or cardiac death

    In general, all deaths are considered cardiac unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.

    Measured: 12 months after angioplasty

  2. Rate of periprocedural MI, Spontaneous MI, or target vessel MI

    According to the DCB-BIF trial definition.

    Measured: 12 months after angioplasty

  3. Rate of clinically-driven TLR or TVR

    Clinically driven revascularization includes repeat PCI or coronary artery bypass graft (CABG) for recurrent or persistent symptomatic ischemia and can be defined according to the relationship to the index PCI (target lesion).

    Measured: 12 months after angioplasty

  4. Rate of thrombosis

    The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.

    Measured: 12 months after angioplasty

Timeline

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

  1. First posted27 Jan 2020
  2. Study start8 Sep 2020
  3. Primary completion27 Jun 2024
  4. Study completion30 Jun 2026 (estimated)

Resources

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 undergo 1:1 randomization to either PS-DCB which will be the treatment group or PS-NCB which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee, Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
784 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04242134
Sponsor's protocol ID
NFH20191128
Acronym
DCB-BIF
Status last verified
Dec 2025
First submitted
20 Jan 2020
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gao XF, Ge Z, Kan J, Kong XQ, Wang Y, Qiu CG, Tresukosol D, He YQ, Wu Q, Li JF, Yuan HT, Shen C, Chen X, Munawar M, Hanif B, Santoso T, Shin ES, Sheiban I, Ye F, Zhang JJ, Chen SL; DCB-BIF investigators. Rationale and design for comparison of non-compliant balloon with drug-coating balloon angioplasty for side branch after provisional stenting for patients with true coronary bifurcation lesions: a prospective, multicentre and randomised DCB-BIF trial. BMJ Open. 2022 Mar 11;12(3):e052788. doi: 10.1136/bmjopen-2021-052788.

    PubMed 35277400

Questions about this trial

What is this clinical trial studying?

A study testing Drug-coating balloon in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. 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?

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?

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?

Rate of major adverse cardiac event (time frame: 12 months after angioplasty). 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 NCT04242134, 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 15 Dec 2025.

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