CompletedNot Applicable

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

China218 participantsStarted 2023-02-20

Plain-language summary

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.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

LLL

Timeframe: 12 months

Trial details

NCT IDNCT05750771

SponsorHenan Institute of Cardiovascular Epidemiology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

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