Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD

April 1, 2026 updated by: Henan Institute of Cardiovascular Epidemiology

Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease

The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.

And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Fuwai Central China Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. older than 60 years of age.
  • 2. meeting the indications for coronary intervention.
  • 3. IVUS examination suggests severe calcified lesions (calcification angle > 270° at the target lesion) ;
  • 4. Target lesion vessel diameter > 2.75 mm

Exclusion Criteria:

  • 1. inability to provide written informed consent.
  • 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
  • 3. the subject is participating in another uncompleted clinical trial
  • 4. life expectancy <1 year.
  • 5. non-in situ vascular lesions.
  • 6. cardiogenic shock.
  • 7. Patients with hemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCB Group
Implantation of drug-coated balloons in patients with satisfactory pretreatment
Device: DCB
Drug-coated balloon with paclitaxel as drug coating
Experimental: DES Group
Implantation of drug-eluting stents in patients with satisfactory pretreatment
Device: DES
Second-generation drug-eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LLL
Time Frame: 12 months
Late lumen loss (LLL) of the target lesion segment
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge
Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction
Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Institute of Cardiovascular Epidemiology

Investigators

  • Study Chair: Muwei Li, MD, Fuwai central China cardiovascular hospotial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanICE202303

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe