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NCT05750771Completed

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

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

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
218 (actual)
First submitted
20 Feb 2023
Start date
20 Feb 2023
Primary completion date
1 Aug 2025
Lead sponsor
Henan Institute of Cardiovascular Epidemiology
NCT number
NCT05750771

What you commit to

  • Study type: Interventional
  • Participants enrolled: 218
  • From 20 Feb 2023 to the primary completion date, 1 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 2\. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.

Other

  • 1\. inability to provide written informed consent.
  • 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

Who the study is looking for

  • 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

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fuwai Central China Cardiovascular Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.