Drug-coated Balloons in Big de Novo Coronary Disease (DCB-LVD)

A Prospective, Multicentric, Randomized Controlled Clinical Trial of Drug-coated Balloons in the Treatment of Big de Novo Coronary Artery Disease

A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.

Study Overview

• Status: Recruiting
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: drug-coated balloon

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years old;
• Asymptomatic myocardial ischemia, stable or unstable angina;
• The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation;
• Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months;
• The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm.

Exclusion Criteria:

• Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months;
• Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol;
• Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants;
• Life expectancy is less than 12 months;
• eGFR≤30ml/min/1.73m2 or blood purification treatment;
• LVEF≤40% or NYHA cardiac function class≥III;
• Clinical conditions of severe hepatic insufficiency and coagulation disorder
• Pregnant or breastfeeding women;
• Participating in another clinical trial and have not completed the primary endpoint observation of the trial;
• Reference lumen diameter > 4.0mm;
• Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion;
• The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy;
• Chronic total occlusive disease;
• Left main stem disease;
• Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions;
• Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DCB treatment; drug-coated balloon in PCI	Device: drug-coated balloon; drug-coated balloon in big de novo coronary disease; Other Names: drug-eluted stent
OTHER: DES treatment; drug-eluted stent in PCI	Device: drug-coated balloon; drug-coated balloon in big de novo coronary disease; Other Names: drug-eluted stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late lumen loss，LLL	late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI	12 months after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target lesion failure，TLF	Cardiac death, target vessel-related myocardial infarction, ischemia-driven target lesion revascularization or target vessel revascularization	12 months after PCI

Collaborators and Investigators

• Sponsor: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (ACTUAL): September 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: drug-coated balloon; de novo coronary disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BJH-DCB-LVD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Published papers

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.: No