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

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ClinicalTrials.gov Identifier: NCT03223974
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Xue Yu, Beijing Hospital

Brief 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 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.

Condition or disease Intervention/treatment Phase
Coronary Disease Device: Paclitaxel DCB Device: DES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Paclitaxel DCB for MB and/or SB
Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM(atmosphere), lasting for >30 seconds
Device: Paclitaxel DCB
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.

Active Comparator: DES in MB
with regular techniques
Device: DES
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.




Primary Outcome Measures :
  1. QCA(quantitative coronary analysis) of efficacy of DCB [ Time Frame: Follow-up coronary angiography at 9 months after the procedure ]
    late lumen loss, minimal lumen diameter


Secondary Outcome Measures :
  1. device-related ischemic events [ Time Frame: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure ]
    including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization

  2. patient-related ischemic events [ Time Frame: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation ]
    all myocardial infarction , any revascularization and all-cause death

  3. ARC(Academic Research Consortium) defined target vessel thrombus events [ Time Frame: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation ]
    definite, probable and possible target vessel thrombus



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
    • 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.

Exclusion Criteria:

  • 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;
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223974


Contacts
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Contact: Xue Yu, MD 00861085132266 ext 2535 yuxuemd@aliyun.com
Contact: Fusui Ji, MD 00861085132266 ext 2535 jifusuivip@126.com

Locations
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China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xin Wang, Dr.    00861058115037    bjyygcp@126.com   
Sponsors and Collaborators
Beijing Hospital
Investigators
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Study Chair: Xue Yu, MD Beijing Hospital

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Responsible Party: Xue Yu, Project manager, Beijing Hospital
ClinicalTrials.gov Identifier: NCT03223974     History of Changes
Other Study ID Numbers: 2016BJYYEC-067-01
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Xue Yu, Beijing Hospital:
Angioplasty
drug-coated balloon
bifurcation

Additional relevant MeSH terms:
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Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action