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

NCT03223974 | Completed

• 1 other identifier: BJYY121-2016003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Keywords

Angioplasty; drug-coated balloon; bifurcation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• device-related ischemic events

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

• patient-related ischemic events

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

• ARC（Academic Research Consortium） defined target vessel thrombus events

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

Study Arms (2)

Paclitaxel DCB for MB and/or SB

EXPERIMENTAL

Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM(atmosphere), lasting for \>30 seconds

Device: Paclitaxel DCB

DES in MB

ACTIVE COMPARATOR

with regular techniques

Device: DES

Interventions

Paclitaxel DCB DEVICE

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.

Paclitaxel DCB for MB and/or SB

DES DEVICE

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.

DES in MB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Xue Yu, MD

  Beijing Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: July 15, 2017
• First Posted: July 21, 2017
• Study Start: November 16, 2017
• Primary Completion: November 30, 2019
• Study Completion: February 28, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)