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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Device: Paclitaxel DCB; Device: DES

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QCA(quantitative coronary analysis) of efficacy of DCB	late lumen loss, minimal lumen diameter	Follow-up coronary angiography at 9 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device-related ischemic events	including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization	Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure
patient-related ischemic events	all myocardial infarction , any revascularization and all-cause death	Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation
ARC（Academic Research Consortium） defined target vessel thrombus events	definite, probable and possible target vessel thrombus	Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation

Collaborators and Investigators

• Sponsor: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: July 15, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: drug-coated balloon; Angioplasty; bifurcation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: BJYY121-2016003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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