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Coronary DiseaseBJDCB-BIFNCT03223974

Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions

A study testing Paclitaxel DCB and DES in people with Coronary Disease, run by Beijing Hospital 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

The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation lesions when compared with traditional single… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Disease
What is being tested?
Paclitaxel DCB and DES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
16 Nov 2017to 28 Feb 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient-related criteria：
  • Patients with stable angina, unstable angina, old myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy;
  • Aged between 18 and 80 years;
  • Consent to receive angiographic follow up at 9 months and clinical follow up at 30 days, 6, 9, 12 and 24 months.
  • Lesion-related criteria：
  • Target lesions of Medina (0,1,1), (1,0,1) or (1,1,1) primary coronary bifurcation lesions without previous intervention therapy;
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  • MB reference vessel diameter between 2.5 mm and 3.5 mm and length ≤30mm; SB reference vessel diameter between 2.0 mm and 3.0 mm and length ≤22 mm;
  • Pre-operative vessel diameter stenosis must ≥70% or ≥50% associated with local ischemia;
  • After lesion predilation, no dissection is seen, or type A/B dissection can be seen, residual stenosis ≤30% and TIMI(thrombolysis in myocardial infarction) grade 3 flow;
  • The distance between other lesions requiring intervention therapy and the target lesion must >10mm ;
  • Only one drug-eluting balloon or drug-eluting stent is used in treatment of MB and SB lesions.

Who cannot join

  • Patient-related criteria：
  • Myocardial infarction in the previous week;
  • Severe congestive heart failure[LVEF <30% or NYHA( New York Heart Association) III/IV)]
  • Severe valvular heart disease;
  • Pregnant or breastfeeding women;
  • Life expectancy no more than 1 year or factors causing difficulties in clinical follow up;
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  • Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents;
  • Intolerance to aspirin and/or clopidogrel;
  • Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy;
  • Leukopenia or thrombopenia;
  • A history of peptic ulcer or GI bleeding in the previously;
  • Stroke within 6 months prior to the operation;
  • A history of severe hepatic or renal failure.
  • Lesion-related criteria ：
  • Extensive thrombosis in the target vessel;
  • Percutaneous coronary intervention of the graft vessel;
  • Chronic total occlusions (pre-operative TIMI grade 0 flow);
  • Left main branch lesions and /or three-vessel lesions requiring treatment;
  • Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation lesions when compared with traditional single drug eluting stent(DES) strategy, so as to simplify the procedure for treatment of coronary bifurcation lesions and extending the clinical indications of paclitaxel DCB in China.

Read the detailed description

Paclitaxel DCB is designed to release anti-proliferative agents to the whole lesion rapidly and homogenously to inhibit excessive neointima proliferation and is associated with rapid healing of endothelium. As a result, DCB therapy reduces the risk of coronary thrombosis. Since only 1 to 3 months duration of dual anti-platelet therapy is required, the bleeding risk associated with prolonged dual anti-platelet therapy (DAPT) is reduced by DCB. Furthermore, there is no permanent residue of foreign bodies in the blood vessels after DCB procedure and this advantage completely eliminates adverse events associated with allergic reactions to metal, polymer and stent fracture. For side branch(SB) with a relatively small lumen in bifurcation lesions, DCB may neglect the lumen loss due to stent scaffolds and cause much less late lumen loss (LLL) than stent therapy does. For main branch(MB), no jailed SBs by the stent and the rate of SB stenosis or even occlusion will be greatly reduced.

Being tested
Paclitaxel DCB, DES
Keywords
Angioplasty, drug-coated balloon, bifurcation
Medical subject headings
Coronary Disease

What participants receive

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

  • Paclitaxel DCBDevice

    Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM, lasting for >30 seconds. If quantitative coronary angiography determines residual stenosis ≤ 30% , it is considered to be a successful operation.

  • DESDevice

    MB should be sufficiently predilated to facilitate the positioning of the stent and the stent residual stenosis should be ≤10% to be a successful operation.

Study groups in NCT03223974
Study groupRoleWhat they receive
Paclitaxel DCB for MB and/or SBExperimentalBalloon/vessel diameter ratio 0.8-1.0, 8-10 ATM(atmosphere), lasting for >30 seconds
Receives: Device: Paclitaxel DCB
DES in MBActive comparatorwith regular techniques
Receives: Device: DES

What is being measured

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

  1. QCA(quantitative coronary analysis) of efficacy of DCB

    late lumen loss, minimal lumen diameter

    Measured: Follow-up coronary angiography at 9 months after the procedure

Secondary outcomes (3)

  1. device-related ischemic events

    including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization

    Measured: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure

  2. patient-related ischemic events

    all myocardial infarction , any revascularization and all-cause death

    Measured: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation

  3. ARC（Academic Research Consortium） defined target vessel thrombus events

    definite, probable and possible target vessel thrombus

    Measured: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation

Timeline

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

  1. First posted21 Jul 2017
  2. Study start16 Nov 2017
  3. Primary completion30 Nov 2019
  4. Study completion28 Feb 2021

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
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223974
Sponsor's protocol ID
BJYY121-2016003
Acronym
BJDCB-BIF
Status last verified
Mar 2022
First submitted
15 Jul 2017
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Paclitaxel DCB and DES in people with Coronary Disease, run by Beijing Hospital 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 11 inclusion and 19 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 Mar 2022. 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?

QCA(quantitative coronary analysis) of efficacy of DCB (time frame: Follow-up coronary angiography at 9 months after the procedure). 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 NCT03223974.

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 Mar 2022.

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